Dosage & administration
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Rinvoq prescribing information
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis
Avoid use of RINVOQ/RINVOQ LQ in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating RINVOQ/RINVOQ LQ in patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
- with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ/RINVOQ LQ. Interrupt RINVOQ/RINVOQ LQ if a patient develops a serious or opportunistic infection.
A patient who develops a new infection during treatment with RINVOQ/RINVOQ LQ should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and RINVOQ/RINVOQ LQ should be interrupted if the patient is not responding to antimicrobial therapy. RINVOQ/RINVOQ LQ may be resumed once the infection is controlled.
Evaluate and test patients for latent and active tuberculosis (TB) infection prior to administration of RINVOQ/RINVOQ LQ. Patients with latent TB should be treated with standard antimycobacterial therapy before initiating RINVOQ/RINVOQ LQ. RINVOQ/RINVOQ LQ should not be given to patients with active TB. Consider anti-TB therapy prior to initiation of RINVOQ/RINVOQ LQ in patients with previously untreated latent TB or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
During RINVOQ/RINVOQ LQ use, monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) and hepatitis B virus reactivation, were reported in clinical trials with RINVOQ
Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ/RINVOQ LQ. Patients who were positive for hepatitis C antibody and hepatitis C virus RNA, were excluded from clinical trials. Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical trials. However, cases of hepatitis B reactivation were still reported in patients enrolled in the Phase 3 trials of RINVOQ. If hepatitis B virus DNA is detected while receiving RINVOQ/RINVOQ LQ, a liver specialist should be consulted.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 3833 adult patients with rheumatoid arthritis were treated with RINVOQ 15 mg or upadacitinib 30 mg tablets once daily in the Phase 3 clinical trials of whom 2806 were exposed for at least one year.
Patients could advance or switch to RINVOQ 15 mg from placebo, or be rescued to RINVOQ from active comparator or placebo from as early as Week 12 depending on the trial design.
A total of 2630 patients received at least 1 dose of RINVOQ 15 mg, of whom 1860 were exposed for at least one year. In trials RA-I, RA-II, RA-III and RA-V, 1213 patients received at least 1 dose of RINVOQ 15 mg, of which 986 patients were exposed for at least one year, and 1203 patients received at least 1 dose of upadacitinib 30 mg, of which 946 were exposed for at least one year.
Adverse Reaction | Placebo | RINVOQ 15 mg |
| N = 1042 (%) | N = 1035 (%) | |
| Upper respiratory tract infection (URTI)* | 9.5 | 13.5 |
| Nausea | 2.2 | 3.5 |
| Cough | 1.0 | 2.2 |
| Pyrexia | 0 | 1.2 |
| *URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection | ||
Other adverse reactions reported in less than 1% of patients in the RINVOQ 15 mg group and at a higher rate than in the placebo group through Week 12 included pneumonia, herpes zoster, herpes simplex (includes oral herpes), and oral candidiasis.
Four integrated datasets are presented in the Specific Adverse Reaction section:
Placebo-controlled Trials: Trials RA-III, RA-IV, and RA-V were integrated to represent safety through 12/14 weeks for placebo (n=1042) and RINVOQ 15 mg (n=1035). Trials RA-III and RA-V were integrated to represent safety through 12 weeks for placebo (n=390), RINVOQ 15 mg (n=385), and upadacitinib 30 mg (n=384). Trial RA-IV did not include the 30 mg dose and, therefore, safety data for upadacitinib 30 mg can only be compared with placebo and RINVOQ 15 mg rates from pooling trials RA-III and RA-V.
MTX-controlled Trials: Trials RA-I and RA-II were integrated to represent safety through 12/14 weeks for MTX (n=530), RINVOQ 15 mg (n=534), and upadacitinib 30 mg (n=529).
12-Month Exposure Dataset: Trials RA-I, II, III, and V were integrated to represent the long-term safety of RINVOQ 15 mg (n=1213) and upadacitinib 30 mg (n=1203).
Exposure adjusted incidence rates were adjusted by trial for all the adverse events reported in this section.
Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, infections were reported in 218 patients (95.7 per 100 patient-years) treated with placebo and 284 patients (127.8 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, infections were reported in 99 patients (136.5 per 100 patient-years) treated with placebo, 118 patients (164.5 per 100 patient-years) treated with RINVOQ 15 mg, and 126 patients (180.3 per 100 patient-years) treated with upadacitinib 30 mg.
MTX-controlled Trials: Infections were reported in 127 patients (119.5 per 100 patient-years) treated with MTX monotherapy, 104 patients (91.8 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 128 patients (115.1 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.
12-Month Exposure Dataset: Infections were reported in 615 patients (83.8 per 100 patient-years) treated with RINVOQ 15 mg and 674 patients (99.7 per 100 patient-years) treated with upadacitinib 30 mg.
Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, serious infections were reported in 6 patients (2.3 per 100 patient-years) treated with placebo, and 12 patients (4.6 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, serious infections were reported in 1 patient (1.2 per 100 patient-years) treated with placebo, 2 patients (2.3 per 100 patient-years) treated with RINVOQ 15 mg, and 7 patients (8.2 per 100 patient-years) treated with upadacitinib 30 mg.
MTX-controlled Trials: Serious infections were reported in 2 patients (1.6 per 100 patient-years) treated with MTX monotherapy, 3 patients (2.4 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 8 patients (6.4 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.
12-Month Exposure Dataset: Serious infections were reported in 38 patients (3.5 per 100 patient-years) treated with RINVOQ 15 mg and 59 patients (5.6 per 100 patient-years) treated with upadacitinib 30 mg.
The most frequently reported serious infections were pneumonia and cellulitis.
Placebo-controlled Trials and MTX-controlled Trials: In the placebo-controlled period, there were no active cases of tuberculosis reported in the placebo, RINVOQ 15 mg, and upadacitinib 30 mg groups. In the MTX-controlled period, there were no active cases of tuberculosis reported in the MTX monotherapy, RINVOQ 15 mg monotherapy, and upadacitinib 30 mg monotherapy groups.
12-Month Exposure Dataset: Active tuberculosis was reported for 2 patients treated with RINVOQ 15 mg and 1 patient treated with upadacitinib 30 mg. Cases of extra-pulmonary tuberculosis were reported.
Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, opportunistic infections were reported in 3 patients (1.2 per 100 patient-years) treated with placebo, and 5 patients (1.9 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, opportunistic infections were reported in 1 patient (1.2 per 100 patient-years) treated with placebo, 2 patients (2.3 per 100 patient-years) treated with RINVOQ 15 mg, and 6 patients (7.1 per 100 patient-years) treated with upadacitinib 30 mg.
MTX-controlled Trials: Opportunistic infections were reported in 1 patient (0.8 per 100 patient-years) treated with MTX monotherapy, 0 patients treated with RINVOQ 15 mg monotherapy, and 4 patients (3.2 per 100 patient-years) treated with upadacitinib 30 mg monotherapy.
12-Month Exposure Dataset: Opportunistic infections were reported in 7 patients (0.6 per 100 patient-years) treated with RINVOQ 15 mg and 15 patients (1.4 per 100 patient-years) treated with upadacitinib 30 mg.
Placebo-controlled Trials: In RA-III, RA-IV, and RA-V, malignancies excluding NMSC were reported in 1 patient (0.4 per 100 patient-years) treated with placebo, and 1 patient (0.4 per 100 patient-years) treated with RINVOQ 15 mg. In RA-III and RA-V, malignancies excluding NMSC were reported in 0 patients treated with placebo, 1 patient (1.1 per 100 patient-years) treated with RINVOQ 15 mg, and 3 patients (3.5 per 100 patient-years) treated with upadacitinib 30 mg.
MTX-controlled Trials: Malignancies excluding NMSC were reported in 1 patient (0.8 per 100 patient-years) treated with MTX monotherapy, 3 patients (2.4 per 100 patient-years) treated with RINVOQ 15 mg monotherapy, and 0 patients treated with upadacitinib 30 mg monotherapy.
12-Month Exposure Dataset: Malignancies excluding NMSC were reported in 13 patients (1.2 per 100 patient-years) treated with RINVOQ 15 mg and 14 patients (1.3 per 100 patient-years) treated with upadacitinib 30 mg.
Placebo-controlled Trials: There were no gastrointestinal perforations (based on medical review) reported in patients treated with placebo, RINVOQ 15 mg, and upadacitinib 30 mg.
MTX-controlled Trials: There were no cases of gastrointestinal perforations reported in the MTX and RINVOQ 15 mg group through 12/14 weeks. Two cases of gastrointestinal perforations were observed in the upadacitinib 30 mg group.
12-Month Exposure Dataset: Gastrointestinal perforations were reported in 1 patient treated with RINVOQ 15 mg and 4 patients treated with upadacitinib 30 mg.
Placebo-controlled Trials: In RA-IV, venous thrombosis (pulmonary embolism or deep vein thrombosis) was observed in 1 patient treated with placebo and 1 patient treated with RINVOQ 15 mg. In RA-V, venous thrombosis was observed in 1 patient treated with RINVOQ 15 mg. There were no observed cases of venous thrombosis reported in RA-III. No cases of arterial thrombosis were observed through 12/14 weeks.
MTX-controlled Trials: In RA-II, venous thrombosis was observed in 0 patients treated with MTX monotherapy, 1 patient treated with RINVOQ 15 mg monotherapy and 0 patients treated with upadacitinib 30 mg monotherapy through Week 14. In RA-II, no cases of arterial thrombosis were observed through 12/14 weeks. In RA-I, venous thrombosis was observed in 1 patient treated with MTX, 0 patients treated with RINVOQ 15 mg and 1 patient treated with upadacitinib 30 mg through Week 24. In RA-I, arterial thrombosis was observed in 1 patient treated with upadacitinib 30 mg through Week 24.
12-Month Exposure Dataset: Venous thrombosis events were reported in 5 patients (0.5 per 100 patient-years) treated with RINVOQ 15 mg and 4 patients (0.4 per 100 patient-years) treated with upadacitinib 30 mg. Arterial thrombosis events were reported in 0 patients treated with RINVOQ 15 mg and 2 patients (0.2 per 100 patient-years) treated with upadacitinib 30 mg.
In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with RINVOQ 15 mg, and in 1.5% and 0.7% of patients treated with placebo, respectively. In RA-III and RA-V, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 1.0% of patients treated with RINVOQ 15 mg, 1.0% and 0% of patients treated with upadacitinib 30 mg and in 1.3% and 1.0% of patients treated with placebo, respectively.
In MTX-controlled trials, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with RINVOQ 15 mg, 1.7% and 1.3% of patients treated with upadacitinib 30 mg and in 1.9% and 0.9% of patients treated with MTX, respectively.
Upadacitinib treatment was associated with dose-related increases in total cholesterol, triglycerides and LDL cholesterol. Upadacitinib was also associated with increases in HDL cholesterol. Elevations in LDL and HDL cholesterol peaked by Week 8 and remained stable thereafter. In controlled trials, for up to 12/14 weeks, changes from baseline in lipid parameters in patients treated with RINVOQ 15 mg and upadacitinib 30 mg, respectively, are summarized below:
- Mean LDL cholesterol increased by 14.81 mg/dL and 17.17 mg/dL.
- Mean HDL cholesterol increased by 8.16 mg/dL and 9.01 mg/dL.
- The mean LDL/HDL ratio remained stable.
- Mean triglycerides increased by 13.55 mg/dL and 14.44 mg/dL.
In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related increases in creatine phosphokinase (CPK) values were observed. CPK elevations > 5 x ULN were reported in 1.0%, and 0.3% of patients over 12/14 weeks in the RINVOQ 15 mg and placebo groups, respectively. Most elevations >5 x ULN were transient and did not require treatment discontinuation. In RA-III and RA-V, CPK elevations > 5 x ULN were observed in 0.3% of patients treated with placebo, 1.6% of patients treated with RINVOQ 15 mg, and none in patients treated with upadacitinib 30 mg.
In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related decreases in neutrophil counts, below 1000 cells/mm3in at least one measurement occurred in 1.1% and <0.1% of patients in the RINVOQ 15 mg and placebo groups, respectively. In RA-III and RA-V, decreases in neutrophil counts below 1000 cells/mm3in at least one measurement occurred in 0.3% of patients treated with placebo, 1.3% of patients treated with RINVOQ 15 mg, and 2.4% of patients treated with upadacitinib 30 mg. In clinical trials, treatment was interrupted in response to ANC less than 1000 cells/mm3.
In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, dose-related decreases in lymphocyte counts below 500 cells/mm3in at least one measurement occurred in 0.9% and 0.7% of patients in the RINVOQ 15 mg and placebo groups, respectively. In RA-III and RA-V, decreases in lymphocyte counts below 500 cells/mm3in at least one measurement occurred in 0.5% of patients treated with placebo, 0.5% of patients treated with RINVOQ 15 mg, and 2.4% of patients treated with upadacitinib 30 mg.
In placebo-controlled trials (RA-III, RA-IV, and RA-V) with background DMARDs, for up to 12/14 weeks, hemoglobin decreases below 8 g/dL in at least one measurement occurred in <0.1% of patients in both the RINVOQ 15 mg and placebo groups. In RA-III and RA-V, hemoglobin decreases below 8 g/dL in at least one measurement were observed in 0.3% of patients treated with placebo, and none in patients treated with RINVOQ 15 mg and upadacitinib 30 mg.
A total of 1827 adult patients with psoriatic arthritis were treated with RINVOQ 15 mg or upadacitinib 30 mg tablets once daily in clinical trials, representing 1639.2 patient-years of exposure, of whom 722 were exposed to upadacitinib for at least one year. In the two Phase 3 trials, 907 patients received at least 1 dose of RINVOQ 15 mg, of whom 359 were exposed for at least one year.
Two placebo-controlled trials were integrated (640 patients on RINVOQ 15 mg once daily and 635 patients on placebo) to evaluate the safety of RINVOQ 15 mg in comparison to placebo for up to 24 weeks after treatment initiation.
Overall, the safety profile observed in patients with active psoriatic arthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis. During the 24-week placebo-controlled period, the frequencies of herpes zoster and herpes simplex were ≥1% (1.1% and 1.4%, respectively) with RINVOQ 15 mg and 0.8% and 1.3%, respectively with placebo. A higher incidence of acne and bronchitis was also observed in patients treated with RINVOQ 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively).
Three Phase 3 (AD-1, AD-2, and AD-3) and one Phase 2b (AD-4) randomized, double-blind, placebo-controlled, multicenter trials evaluated the safety of RINVOQ in patients with moderate-to-severe atopic dermatitis. The majority of patients were White (68%) and male (57%). The mean age was 34 years (ranged from 12 to 75 years) and 13% of the patients were 12 to less than 18 years. In these 4 trials, 2612 patients were treated with RINVOQ 15 mg tablets or 30 mg tablets orally once daily, with or without concomitant topical corticosteroids (TCS).
In the Phase 3 clinical trials (AD-1, AD-2, and AD-3), a total of 1239 patients received RINVOQ 15 mg, of whom 791 were exposed for at least one year and 1246 patients received RINVOQ 30 mg, of whom 826 were exposed for at least one year.
Trials AD-1, AD-2, and AD-4 compared the safety of RINVOQ monotherapy to placebo through Week 16. Trial AD-3 compared the safety of RINVOQ + TCS to placebo + TCS through Week 16.
In RINVOQ trials with and without TCS (Trials AD-1, 2, 3 and 4) through Week 16, the proportion of patients who discontinued treatment because of adverse reactions in the RINVOQ 15 mg, 30 mg and placebo groups were 2.3%, 2.9% and 3.8%, respectively. Table 5 summarizes the adverse reactions that occurred at a rate of at least 1% in the RINVOQ 15 mg or 30 mg groups during the first 16 weeks of treatment.
Adverse Reaction | Placebo | RINVOQ 15 mg | RINVOQ 30 mg |
| N = 902 (%) | N = 899 (%) | N = 906 (%) | |
| Upper respiratory tract infection (URTI)* | 17 | 23 | 25 |
| Acne** | 2 | 10 | 16 |
| Herpes simplex*** | 2 | 4 | 8 |
| Headache | 4 | 6 | 6 |
| Increased blood creatine phosphokinase | 2 | 5 | 6 |
| Cough | 1 | 3 | 3 |
| Hypersensitivity**** | 2 | 2 | 3 |
| Folliculitis | 1 | 2 | 3 |
| Nausea | 1 | 3 | 3 |
| Abdominal pain***** | 1 | 3 | 2 |
| Pyrexia | 1 | 2 | 2 |
| Increased Weight | 1 | 2 | 2 |
| Herpes zoster****** | 1 | 2 | 2 |
| Influenza | <1 | 2 | 2 |
| Fatigue | 1 | 1 | 2 |
| Neutropenia | <1 | 1 | 2 |
| Myalgia | 1 | 1 | 2 |
| Influenza like illness | 1 | 1 | 2 |
| * Includes: laryngitis, laryngitis viral, nasopharyngitis, oropharyngeal pain, pharyngeal abscess, pharyngitis, pharyngitis streptococcal, pharyngotonsillitis, respiratory tract infection, respiratory tract infection viral, rhinitis, rhinolaryngitis, sinusitis, tonsillitis, tonsillitis bacterial, upper respiratory tract infection, viral pharyngitis, viral upper respiratory tract infection ** Includes: acne and dermatitis acneiform *** Includes: genital herpes, genital herpes simplex, herpes dermatitis, herpes ophthalmic, herpes simplex, nasal herpes, ophthalmic herpes simplex, herpes virus infection, oral herpes **** Includes anaphylactic reaction, anaphylactic shock, angioedema, dermatitis exfoliative generalized, drug hypersensitivity, eyelid oedema, face oedema, hypersensitivity, periorbital swelling, pharyngeal swelling, swelling face, toxic skin eruption, type I hypersensitivity, urticaria ***** Includes abdominal pain and abdominal pain upper ****** Includes herpes zoster and varicella | |||
Other adverse reactions reported in less than 1% of patients in the RINVOQ 15 mg and/or 30 mg group and at a higher rate than in the placebo group through Week 16 included anemia, oral candidiasis, pneumonia, non-melanoma skin cancer, and the adverse event of retinal detachment.
The safety profile of RINVOQ through Week 52 was generally consistent with the safety profile observed at Week 16.
Overall, the safety profile observed in patients with AD treated with RINVOQ was similar to the safety profile in patients with RA. Other specific adverse reactions that were reported in patients with AD included eczema herpeticum/Kaposi’s varicelliform eruption.
Placebo-controlled Period (16 weeks): Eczema herpeticum was reported in 4 patients (1.6 per 100 patient-years) treated with placebo, 6 patients (2.2 per 100 patient-years) treated with RINVOQ 15 mg and 7 patients (2.6 per 100 patient-years) treated with RINVOQ 30 mg.
12-Month Exposure (Weeks 0 to 52): Eczema herpeticum was reported in 18 patients (1.6 per 100 patient-years) treated with RINVOQ 15 mg and 17 patients (1.5 per 100 patient-years) treated with RINVOQ 30 mg.
RINVOQ was studied up to 8 weeks in patients with moderately to severely active ulcerative colitis in two randomized, double-blind, placebo-controlled induction studies (UC-1, UC-2) and a randomized, double-blind, placebo controlled, dose-finding study (UC-4; NCT02819635). Long term safety up to 52-weeks was evaluated in patients who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (UC-3) and a long-term extension study
In the two induction studies (UC-1, UC-2) and a dose finding study (UC-4), 1097 patients were enrolled of whom 719 patients received RINVOQ 45 mg tablets once daily.
In the maintenance study (UC-3), 746 patients were enrolled of whom 250 patients received RINVOQ 15 mg tablets once daily and 251 patients received RINVOQ 30 mg tablets once daily.
Adverse reactions reported in ≥2% of patients in any treatment arm in the induction and maintenance studies are shown in Tables 6 and 7, respectively.
Adverse Reaction | Placebo | RINVOQ 45 mg Once Daily |
| N = 378 (%) | N = 719 (%) | |
| Upper respiratory tract infection* | 7 | 9 |
| Acne* | 1 | 6 |
| Increased blood creatine phosphokinase | 1 | 5 |
| Neutropenia* | <1 | 5 |
| Rash* | 1 | 4 |
| Elevated liver enzymes** | 2 | 3 |
| Lymphopenia* | 1 | 3 |
| Folliculitis | 1 | 2 |
| Herpes simplex* | <1 | 2 |
| * Composed of several similar terms ** Elevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury and cholestasis. | ||
Other adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 8 included herpes zoster and pneumonia.
Adverse Reaction | Placebo | RINVOQ 15 mg Once Daily | RINVOQ 30 mg Once Daily |
| N = 245 (%) | N = 250 (%) | N = 251 (%) | |
| Upper respiratory tract infection* | 18 | 17 | 20 |
| Increased blood creatine phosphokinase | 2 | 6 | 8 |
| Pyrexia | 3 | 3 | 6 |
| Neutropenia* | 2 | 3 | 6 |
| Elevated liver enzymes** | 1 | 6 | 4 |
| Rash* | 4 | 5 | 5 |
| Herpes zoster | 0 | 5 | 6 |
| Folliculitis | 2 | 2 | 4 |
| Hypercholesterolemia* | 1 | 2 | 4 |
| Influenza | 1 | 3 | 3 |
| Herpes simplex* | 1 | 2 | 3 |
| Lymphopenia* | 2 | 3 | 2 |
| Hyperlipidemia* | 0 | 2 | 2 |
| 1Patients who were responders to 8 weeks induction therapy with RINVOQ 45 mg once daily * Composed of several similar terms ** Elevated liver enzymes composed of elevated ALT, AST, GGT, ALP, liver transaminases, hepatic enzymes, bilirubin, drug-induced liver injury, and cholestasis. | |||
The adverse reaction of non-melanoma skin cancer was reported in 1% of patients in the RINVOQ 30 mg group and none of the patients in the RINVOQ 15 mg or placebo group through Week 52.
The safety profile of RINVOQ in the long-term extension study was similar to the safety profile observed in the placebo-controlled induction and maintenance periods.
Overall, the safety profile observed in patients with ulcerative colitis treated with RINVOQ was generally similar to the safety profile in patients with RA and AD.
Induction Studies: In UC-1, UC-2, and UC-4, serious infections were reported in 5 patients (8.4 per 100 patient-years) treated with placebo and 9 patients (8.4 per 100 patient-years) treated with RINVOQ 45 mg through 8 weeks.
Placebo-controlled Maintenance Study: In UC-3, serious infections were reported in 8 patients (5.9 events per 100 patient-years) treated with placebo, 9 patients (5.0 events per 100 patient-years) treated with RINVOQ 15 mg, and 8 patients (3.7 events per 100 patient-years) treated with RINVOQ 30 mg through 52 weeks.
In studies UC-1, UC-2, and UC-4, elevations of ALT to ≥ 3 x ULN in at least one measurement were observed in 1.5% of patients treated with RINVOQ 45 mg, and 0% of patients treated with placebo for 8 weeks. AST elevations to ≥ 3 x ULN occurred in 1.5% of patients treated with RINVOQ 45 mg, and 0.3% of patients treated with placebo. Elevations of ALT to ≥ 5 x ULN occurred in 0.4% of patients treated with RINVOQ 45 mg and 0% of patients treated with placebo.
In UC-3, elevations of ALT to ≥ 3 x ULN in at least one measurement were observed in 4.4% of patients treated with RINVOQ 30 mg, 2% of patients treated with RINVOQ 15 mg, and 1.2% of patients treated with placebo for 52 weeks. Elevations of AST to ≥ 3 x ULN in at least one measurement were observed in 2% of patients treated with RINVOQ 30 mg, 1.6% of patients treated with RINVOQ 15 mg and 0.4% of patients treated with placebo. Elevations of ALT to ≥ 5 x ULN were observed in 1.2% of patients treated with 30 mg, 0.4% of patients treated with 15 mg, and 0.4% of patients treated with placebo.
Overall, laboratory abnormalities observed in patients with ulcerative colitis treated with RINVOQ were similar to those described in patients with RA.
RINVOQ was studied up to 12 weeks in patients with moderately to severely active CD in two randomized, double-blind, placebo-controlled induction studies (CD-1, CD-2). Long term safety up to 52 weeks was evaluated in patients who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance study (CD-3), with additional data provided from a long-term extension (LTE) period
In the two induction studies (CD-1, CD-2), 1021 patients were enrolled, of whom 674 patients received RINVOQ 45 mg tablets once daily during the placebo-controlled period.
In the maintenance study (CD-3), 673 patients were enrolled, of whom 221 patients received RINVOQ 15 mg tablets once daily and 229 patients received RINVOQ 30 mg tablets once daily during the randomized, placebo-controlled period.
Overall, the safety profile observed in patients with Crohn’s disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
Adverse reactions reported in ≥2% of patients treated with RINVOQ and at a higher rate than placebo in the induction and maintenance studies are shown in Tables 8 and 9, respectively.
Adverse Reaction | Placebo | RINVOQ 45 mg Once Daily |
| N = 347 (%) | N = 674 (%) | |
| Upper respiratory tract infection* | 8 | 13 |
| Anemia* | 6 | 7 |
| Acne* | 2 | 6 |
| Pyrexia | 3 | 4 |
| Increased blood creatine phosphokinase | 1 | 3 |
| Influenza | 1 | 3 |
| Herpes simplex* | 1 | 3 |
| Leukopenia* | 1 | 2 |
| Neutropenia* | <1 | 2 |
| Herpes zoster | 0 | 2 |
| * Composed of several similar terms | ||
Adverse reactions reported in less than 2% of patients in the RINVOQ 45 mg group and at a higher rate than in the placebo group through Week 12 included folliculitis, hypercholesterolemia, bronchitis, pneumonia, oral candidiasis, and hyperlipidemia.
Adverse Reaction | Placebo | RINVOQ 15 mg Once Daily | RINVOQ 30 mg Once Daily |
| N = 223 (%) | N = 221 (%) | N = 229 (%) | |
| Upper respiratory tract infection* | 11 | 14 | 12 |
| Pyrexia | 2 | 3 | 7 |
| Herpes zoster* | 2 | 3 | 5 |
| Headache* | 1 | 3 | 5 |
| Acne* | 3 | 2 | 5 |
| Gastroenteritis* | 2 | 3 | 3 |
| Fatigue | 2 | 3 | 3 |
| Increased blood creatine phosphokinase | 1 | 2 | 3 |
| Elevated liver enzymes2 | <1 | 2 | 3 |
| Leukopenia* | <1 | 1 | 2 |
| Neutropenia* | <1 | 1 | 2 |
| Bronchitis* | 0 | 1 | 2 |
| Pneumonia* | 1 | 4 | 1 |
| Cough | 2 | 3 | 1 |
| 1Patients who were responders to 12 weeks induction therapy with RINVOQ 45 mg once daily. 2Elevated liver enzymes includes alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, transaminases increased, blood bilirubin increased. * Composed of several similar terms | |||
Adverse reactions reported in less than 2% of patients in the RINVOQ 15 mg or 30 mg group and at a higher rate than in the placebo group through Week 52 included hyperlipidemia, oral candidiasis, and hypercholesterolemia.
The safety profile of RINVOQ in the long-term extension study was similar to the safety profile observed in the placebo-controlled induction and maintenance periods.
Induction Studies: In CD-1 and CD-2, serious infections were reported in 6 patients (8 per 100 patient-years) treated with placebo and 13 patients (9 per 100 patient-years) treated with RINVOQ 45 mg through 12 weeks of the placebo-controlled period.
Maintenance Study/LTE: In the long-term placebo-controlled period, serious infections were reported in 10 patients (7 per 100 patient-years) treated with placebo, 7 patients (4 per 100 patient-years) treated with RINVOQ 15 mg, and 13 patients (6 per 100 patient-years) treated with RINVOQ 30 mg.
Induction Studies: During the induction studies in all patients treated with RINVOQ 45 mg (N=938), gastrointestinal perforation was reported in 4 patients (2 per 100 patient-years). In the placebo-controlled induction period, in CD-1 and CD-2, gastrointestinal perforation was reported in no patients treated with placebo (N=347) and 1 patient (1 per 100 patient-years) treated with RINVOQ 45 mg (N=674) through 12 weeks.
Maintenance Study/LTE: In the long-term placebo-controlled period, gastrointestinal perforation was reported in 1 patient (1 per 100 patient-years) treated with placebo, 1 patient (<1 per 100 patient-years) treated with RINVOQ 15 mg, and 1 patient (<1 per 100 patient-years) treated with RINVOQ 30 mg.
Patients who received placebo or RINVOQ 15 mg for maintenance therapy and lost response were treated with rescue RINVOQ 30 mg (N=336). Among these patients, gastrointestinal perforation was reported in 3 patients (1 per 100 patient-years) through long-term treatment.
A total of 596 patients with ankylosing spondylitis were treated with RINVOQ 15 mg tablets in the two clinical trials representing 577.3 patient-years of exposure, of whom 220 were exposed to RINVOQ 15 mg for at least one year.
Overall, the safety profile observed in patients with active ankylosing spondylitis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis. During the 14-week placebo-controlled period in Trial AS-I, the frequency of headache was 5.4% with RINVOQ 15 mg and 2.1% with placebo. During the 14-week placebo-controlled period in Trial AS-II, the frequency of headache was 3.3% with RINVOQ 15 mg and 1.4% with placebo.
A total of 187 patients with non-radiographic axial spondyloarthritis were treated with RINVOQ 15 mg tablets in the clinical trial representing 116.6 patient-years of exposure, of whom 31 were exposed to RINVOQ 15 mg for at least one year.
Overall, the safety profile observed in patients with active non-radiographic axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
A total of 83 pediatric patients with juvenile idiopathic arthritis (JIA) with active polyarthritis were treated with RINVOQ/RINVOQ LQ in the clinical trial, representing 123.7 patient-years of exposure, of whom 48 were exposed to RINVOQ/RINVOQ LQ for at least one year.
Overall, the safety profile observed in pediatric patients with JIA with active polyarthritis treated with RINVOQ/RINVOQ LQ was consistent with the known safety profile of RINVOQ.
In the Phase 3 study, 209 patients with giant cell arteritis received at least 1 dose of RINVOQ 15 mg, of whom 122 were exposed for at least one year during the 52-week placebo-controlled period. The safety profile observed in patients with giant cell arteritis was generally consistent with the known safety profile for RINVOQ.
Adverse Reaction | Placebo | RINVOQ 15 mg |
| N = 112 (%) | N = 209 (%) | |
| Upper respiratory tract infection (URTI)a | 20.5 | 21.5 |
| Headache | 11.6 | 16.3 |
| Fatigue | 5.4 | 9.1 |
| Peripheral edemab | 2.7 | 8.6 |
| Coughc | 3.6 | 7.2 |
| Anemiad | 2.7 | 6.7 |
| Rashe | 2.7 | 5.7 |
| Herpes zosterf | 2.7 | 5.3 |
| Nausea | 3.6 | 5.3 |
| aIncludes acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, viral pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection, upper respiratory tract infection bIncludes edema and edema peripheral cIncludes cough and productive cough dIncludes anemia, iron deficiency anemia, blood iron decreased, hemoglobin decreased, mean cell volume increased eIncludes rash, rash erythematous, rash macular, rash maculo-papular, rash vesicular fIncludes herpes zoster, herpes zoster oticus, ophthalmic herpes zoster | ||
In the 52-week placebo-controlled period, opportunistic infections were reported in 1 patient (1.1 per 100 patient-years) treated with placebo and 4 patients (2.3 per 100 patient-years) treated with RINVOQ 15 mg.
In the 52-week placebo-controlled period, venous thromboembolic events (pulmonary embolism or deep vein thrombosis) were observed in 4 patients (4.3 per 100 patient-years) treated with placebo and 7 patients (3.9 per 100 patient-years) treated with RINVOQ 15 mg. Events of arterial thrombosis were observed in 2 patients (1.1 per 100 patient-years) treated with RINVOQ 15 mg and 0 patients treated with placebo.
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ/RINVOQ LQuse and during therapy. Treatment for latent infection should be considered prior to RINVOQ/RINVOQ LQuse.
- Invasive fungal infections, including cryptococcosis and pneumocystosis.
- Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis
Avoid use of RINVOQ/RINVOQ LQ in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating RINVOQ/RINVOQ LQ in patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
- with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ/RINVOQ LQ. Interrupt RINVOQ/RINVOQ LQ if a patient develops a serious or opportunistic infection.
A patient who develops a new infection during treatment with RINVOQ/RINVOQ LQ should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and RINVOQ/RINVOQ LQ should be interrupted if the patient is not responding to antimicrobial therapy. RINVOQ/RINVOQ LQ may be resumed once the infection is controlled.
Evaluate and test patients for latent and active tuberculosis (TB) infection prior to administration of RINVOQ/RINVOQ LQ. Patients with latent TB should be treated with standard antimycobacterial therapy before initiating RINVOQ/RINVOQ LQ. RINVOQ/RINVOQ LQ should not be given to patients with active TB. Consider anti-TB therapy prior to initiation of RINVOQ/RINVOQ LQ in patients with previously untreated latent TB or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Consultation with a physician with expertise in the treatment of TB is recommended to aid in the decision about whether initiating anti-TB therapy is appropriate for an individual patient.
During RINVOQ/RINVOQ LQ use, monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster) and hepatitis B virus reactivation, were reported in clinical trials with RINVOQ
Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ/RINVOQ LQ. Patients who were positive for hepatitis C antibody and hepatitis C virus RNA, were excluded from clinical trials. Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical trials. However, cases of hepatitis B reactivation were still reported in patients enrolled in the Phase 3 trials of RINVOQ. If hepatitis B virus DNA is detected while receiving RINVOQ/RINVOQ LQ, a liver specialist should be consulted.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ/RINVOQ LQ.
Malignancies, including lymphomas, were observed in clinical trials of RINVOQ
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding NMSC) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. In this study, current or past smokers had an additional increased risk of overall malignancies.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ/RINVOQ LQ, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.
NMSCs have been reported in patients treated with RINVOQ. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE) defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with RINVOQ/RINVOQ LQ, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue RINVOQ/RINVOQ LQ in patients that have experienced a myocardial infarction or stroke.
In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.
If symptoms of thrombosis occur, patients should discontinue RINVOQ/RINVOQ LQ and be evaluated promptly and treated appropriately. Avoid RINVOQ/RINVOQ LQ in patients that may be at increased risk of thrombosis.
| Boxed Warning | 4/2025 |
Indications and Usage (1.9 Giant Cell Arteritis RINVOQ is indicated for the treatment of adults with giant cell arteritis.
| 4/2025 |
Indications and Usage (1.4 Ulcerative Colitis RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.
1.5 Crohn’s Disease RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.
| 10/2025 |
Dosage and Administration (2.11 Recommended Dosage in Giant Cell Arteritis The recommended dosage of RINVOQ is 15 mg once daily in combination with a tapering course of corticosteroids. RINVOQ 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids. 2.1 2 Recommended Dosage in Patients with Renal Impairment or Hepatic Impairment Renal Impairment Rheumatoid Arthritis , Psoriatic Arthritis , Ankylosing Spondylitis , Non-radiographic Axial Spondyloarthritis , pJIA , and Giant Cell Arteritis :
Atopic Dermatitis:
Ulcerative Colitis:
Crohn’s Disease:
Hepatic Impairment RINVOQ/RINVOQ LQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] .Rheumatoid Arthritis , Psoriatic Arthritis , Atopic Dermatitis , Ankylosing Spondylitis , Non-radiographic Axial Spondyloarthritis , pJIA , and Giant Cell Arteritis : No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). Ulcerative Colitis: For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
Crohn’s Disease: For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
2.000000000000000e+00 1 3 Dosage Modifications Due to Drug Interactions Rheumatoid Arthritis, Psoriatic Arthritis, Ankylos ing Spondylitis , Non-radiographic Axial Spondyloarthritis , pJIA , and Giant Cell Arteritis No dosage adjustment is needed in patients receiving strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] .Atopic Dermatitis The recommended dosage of RINVOQ in patients receiving strong CYP3A4 inhibitors is 15 mg once daily [see Drug Interactions ( 7.1 )] .Ulcerative Colitis The recommended dosage of RINVOQ in patients with ulcerative colitis receiving strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )]:
Crohn’s Disease The recommended dosage of RINVOQ in patients with Crohn’s disease receiving strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 )] :
| 4/2025 |
Warnings and Precautions (5.000000000000000e+00 5 Thrombosis Thromboses, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including RINVOQ. Many of these adverse events were serious and some resulted in death [see Adverse Reactions ( 6.1 )] .In a large, randomized, postmarketing safety study of another JAK inhibitor in RA patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. If symptoms of thrombosis occur, patients should discontinue RINVOQ/RINVOQ LQ and be evaluated promptly and treated appropriately. Avoid RINVOQ/RINVOQ LQ in patients that may be at increased risk of thrombosis. | 4/2025 |
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor.
- RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ()1.1 Rheumatoid Arthritis
RINVOQ®is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.1 Rheumatoid ArthritisRINVOQ®is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ()1.2 Psoriatic Arthritis
RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitationsof Use
RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.2 Psoriatic ArthritisRINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. ()1.3 Atopic Dermatitis
RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants. ()1.3 Atopic DermatitisRINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
- RINVOQ is indicated for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. ()1.4 Ulcerative ColitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.4 Ulcerative ColitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for UC, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is indicated for the treatment of adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ. ()1.5 Crohn’s DiseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.5 Crohn’s DiseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. If TNF blockers are clinically inadvisable, patients should have received at least one approved systemic therapy prior to use of RINVOQ.- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biological therapies for CD, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers. ()1.000000000000000e+006Ankylosing Spondylitis
RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.000000000000000e+006Ankylosing SpondylitisRINVOQ is indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy. ()1.000000000000000e+007Non-radiographic Axial Spondyloarthritis
RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.000000000000000e+007Non-radiographic Axial SpondyloarthritisRINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. ()1.8 Polyarticular Juvenile Idiopathic Arthritis
RINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.8 Polyarticular Juvenile Idiopathic ArthritisRINVOQ/RINVOQ LQ is indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers.
- Limitations of Use: RINVOQ/RINVOQ LQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQ is indicated for the treatment of adults with giant cell arteritis ()1.9 Giant Cell ArteritisRINVOQ is indicated for the treatment of adults with giant cell arteritis.
- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
Limitations of Use
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ()1.9 Giant Cell ArteritisRINVOQ is indicated for the treatment of adults with giant cell arteritis.- Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
- RINVOQLQoral solutionis not substitutable withRINVOQ extended-release tablets(,2.2Important Administration Instructions
- RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets[see Dosage and Administration (2.4,2.10)].
- Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.
- RINVOQ/RINVOQ LQ should be taken orally with or without food[see Clinical Pharmacology (12.3)].
- RINVOQ tablets should be swallowed whole. RINVOQ tablets should not be split, crushed, or chewed.
- RINVOQ LQ should be administered using the provided press-in bottle adapter and oral dosing syringe[seeInstructions for Use].
- RINVOQ LQ is dosed twice daily[see Dosage and Administration (2.4,2.10)].
).2.000000000000000e+0010Recommended Dosage inPolyarticular Juvenile Idiopathic ArthritisThe recommended dosage is based on body weight (Table 2).
Table 2: RINVOQ/RINVOQ LQ Dosage for Patients 2 years and older with pJIA Patient WeightRINVOQ LQRINVOQ10 kg to less than 20 kg3 mg (3 mL oral solution) twice dailyNot recommended20 kg to less than 30 kg4 mg (4 mL oral solution) twice dailyNot recommended30 kg and greater6 mg (6 mL oral solution) twice daily15 mg (one 15 mg tablet) once dailyRINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.
- RINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets
- Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the healthcare provider.
- Prior to treatment update immunizations and consider evaluating for active and latent tuberculosis, viral hepatitis, hepatic function, and pregnancy status ()2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation
Prior to RINVOQ/RINVOQ LQ treatment initiation, consider performing the following evaluations:
- Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use[see Warnings and Precautions (5.1)].
- Viral hepatitis screening in accordance with clinical guidelines – RINVOQ/RINVOQ LQ initiation is not recommended in patients with active hepatitis B or hepatitis C[see Warnings and Precautions (5.1)].
- A complete blood count – RINVOQ/RINVOQ LQ initiation is not recommended in patients with an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL[see Dosage and Administration (2.14) and Warnings and Precautions (5.8)].
- Baseline hepatic function: RINVOQ/RINVOQ LQ initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C)[see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
- Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment[see Warnings and Precautions (5.9) and Use in Specific Populations (8.1,8.3)].
Update immunizations according to current immunization guidelines
[see Warnings and Precautions (5.10)]. - Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use
- Avoid initiation or interrupt RINVOQ/RINVOQ LQ if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count is less than 1000 cells/mm3, or hemoglobin level is less than 8 g/dL. (,2.1Recommended Evaluations and Immunizations Prior to Treatment Initiation
Prior to RINVOQ/RINVOQ LQ treatment initiation, consider performing the following evaluations:
- Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use[see Warnings and Precautions (5.1)].
- Viral hepatitis screening in accordance with clinical guidelines – RINVOQ/RINVOQ LQ initiation is not recommended in patients with active hepatitis B or hepatitis C[see Warnings and Precautions (5.1)].
- A complete blood count – RINVOQ/RINVOQ LQ initiation is not recommended in patients with an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL[see Dosage and Administration (2.14) and Warnings and Precautions (5.8)].
- Baseline hepatic function: RINVOQ/RINVOQ LQ initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C)[see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
- Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to starting treatment[see Warnings and Precautions (5.9) and Use in Specific Populations (8.1,8.3)].
Update immunizations according to current immunization guidelines
[see Warnings and Precautions (5.10)].)2.000000000000000e+0014Dosage InterruptionInfectionsIf a patient develops a serious infection, including serious opportunistic infection, interrupt RINVOQ/RINVOQ LQ treatment until the infection is controlled
[see Warnings and Precautions (5.1)].Laboratory AbnormalitiesInterruption of dosing may be needed for management of laboratory abnormalities as described in Table 3
[see Warnings and Precautions (5.8)].Table 3: Recommended Dosage Interruptions for Laboratory Abnormalities Laboratory MeasureActionAbsolute Neutrophil Count (ANC) Interrupt treatment if ANC is less than 1000 cells/mm3; treatment may be restarted once ANC returns above this value Absolute Lymphocyte Count (ALC) Interrupt treatment if ALC is less than 500 cells/mm3; treatment may be restarted once ALC returns above this value Hemoglobin (Hb) Interrupt treatment if Hb is less than 8 g/dL; treatment may be restarted once Hb returns above this value Hepatic transaminases Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. - Active and latent tuberculosis (TB) infection evaluation - If positive, treat for TB prior to RINVOQ/RINVOQ LQ use
- Adults:The recommended dosage of RINVOQ is 15 mg once daily. (,2.3Recommended Dosage in Rheumatoid Arthritis
The recommended dosage of RINVOQ is 15 mg once daily.
,2.000000000000000e+008Recommended Dosage inAnkylosing SpondylitisThe recommended dosage of RINVOQ is 15 mg once daily.
)2.000000000000000e+009RecommendedDosage in Non-radiographic Axial SpondyloarthritisThe recommended dosage of RINVOQ is 15 mg once daily.
- Pediatric Patients 2 to less than 18 Years of Age Weighing at Least 10 kg:The recommended dosage is based on body weight ()2.000000000000000e+004Recommended Dosage in Psoriatic ArthritisPediatric Patients 2 to Less Than 18 Years of Age
The recommended dosage is based on body weight .
Table 1: RINVOQ/RINVOQ LQ Dosage for Pediatric Patients 2 Years to Less Than 18 Years of Age with Psoriatic Arthritis Patient WeightRINVOQ LQRINVOQ10 kg to less than 20 kg3 mg (3 mL oral solution) twice dailyNot recommended20 kg to less than 30 kg4 mg (4 mL oral solution) twice dailyNot recommended30 kg and greater6 mg (6 mL oral solution) twice daily15 mg (one 15 mg tablet) once dailyRINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.
Adults 18 Years of Age and OlderThe recommended dosage of RINVOQ is 15 mg once daily.
- Adults:The recommended dosage of RINVOQ is 15 mg once daily. ()2.000000000000000e+004Recommended Dosage in Psoriatic ArthritisPediatric Patients 2 to Less Than 18 Years of Age
The recommended dosage is based on body weight .
Table 1: RINVOQ/RINVOQ LQ Dosage for Pediatric Patients 2 Years to Less Than 18 Years of Age with Psoriatic Arthritis Patient WeightRINVOQ LQRINVOQ10 kg to less than 20 kg3 mg (3 mL oral solution) twice dailyNot recommended20 kg to less than 30 kg4 mg (4 mL oral solution) twice dailyNot recommended30 kg and greater6 mg (6 mL oral solution) twice daily15 mg (one 15 mg tablet) once dailyRINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.
Adults 18 Years of Age and OlderThe recommended dosage of RINVOQ is 15 mg once daily.
- Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age:Initiate treatment with RINVOQ 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily. ()2.5 Recommended Dosage in Atopic DermatitisPediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age
Initiate treatment with RINVOQ 15 mg once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response.
Adults 65 Years of Age and OlderThe recommended dosage of RINVOQ is 15 mg once daily.
- Adults65 Years of Ageand Older: Recommended dosage of RINVOQ is 15 mg once daily. ()2.5 Recommended Dosage in Atopic DermatitisPediatric Patients 12 Years of Age and Older Weighing at Least 40 kg and Adults Less Than 65 Years of Age
Initiate treatment with RINVOQ 15 mg once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg once daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response.
Adults 65 Years of Age and OlderThe recommended dosage of RINVOQ is 15 mg once daily.
- SevereRenal Impairment: Recommended dosage of RINVOQ is 15 mg once daily. ()2.12Recommended Dosage in Patients with Renal Impairment or Hepatic ImpairmentRenal ImpairmentRheumatoid Arthritis,Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:
- No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.
Atopic Dermatitis:- For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to < 30 mL/min/1.73m2] the recommended dosage of RINVOQ is 15 mg once daily[see Use in Specific Populations (8.6)].
- No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Ulcerative Colitis:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 8 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Crohn’s Disease:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 12 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Hepatic ImpairmentRINVOQ/RINVOQ LQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C)
[see Use in Specific Populations (8.7)].Rheumatoid Arthritis,Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B).
Ulcerative Colitis:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 8 weeks
- Maintenance:15 mg once daily
Crohn’s Disease:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 12 weeks
- Maintenance:15 mg once daily
- Adults:The recommended induction dosage of RINVOQ is 45 mg once daily for 8 weeks. The recommended maintenance dosage of RINVOQ is 15 mg once daily. A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response. ()2.6 Recommended Dosage in Ulcerative ColitisAdult Patients: Induction
The recommended induction dosage of RINVOQ is 45 mg once daily for 8 weeks.
Adult Patients: MaintenanceThe recommended dosage of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
- See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions. (,2.12Recommended Dosage in Patients with Renal Impairment or Hepatic ImpairmentRenal ImpairmentRheumatoid Arthritis,Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:
- No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.
Atopic Dermatitis:- For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to < 30 mL/min/1.73m2] the recommended dosage of RINVOQ is 15 mg once daily[see Use in Specific Populations (8.6)].
- No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Ulcerative Colitis:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 8 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Crohn’s Disease:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 12 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Hepatic ImpairmentRINVOQ/RINVOQ LQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C)
[see Use in Specific Populations (8.7)].Rheumatoid Arthritis,Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B).
Ulcerative Colitis:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 8 weeks
- Maintenance:15 mg once daily
Crohn’s Disease:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 12 weeks
- Maintenance:15 mg once daily
)2.000000000000000e+0013Dosage Modifications Due to Drug InteractionsRheumatoid Arthritis, Psoriatic Arthritis,AnkylosingSpondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell ArteritisNo dosage adjustment is needed in patients receiving strong CYP3A4 inhibitors
[see Drug Interactions (7.1)].Atopic DermatitisThe recommended dosage of RINVOQ in patients receiving strong CYP3A4 inhibitors is 15 mg once daily
[see Drug Interactions (7.1)].Ulcerative ColitisThe recommended dosage of RINVOQ in patients with ulcerative colitis receiving strong CYP3A4 inhibitors
[see Drug Interactions(7.1)]:- Induction:30 mg once daily for 8 weeks
- Maintenance:15 mg once daily
Crohn’s DiseaseThe recommended dosage of RINVOQ in patients with Crohn’s disease receiving strong CYP3A4 inhibitors
[see Drug Interactions (7.1)]:- Induction:30 mg once daily for 12 weeks
- Maintenance:15 mg once daily
- Adults:The recommended induction dosage of RINVOQ is 45 mg once daily for 12 weeks. The recommended maintenance dosage of RINVOQ is 15 mg once daily. A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response. ()2.7 Recommended Dosage in Crohn’s DiseaseAdult Patients: Induction
The recommended induction dosage of RINVOQ is 45 mg once daily for 12 weeks.
Adult Patients: MaintenanceThe recommended dosage of RINVOQ for maintenance treatment is 15 mg once daily. A dosage of 30 mg once daily may be considered for patients with refractory, severe or extensive disease. Discontinue RINVOQ if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
- See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions. (,2.12Recommended Dosage in Patients with Renal Impairment or Hepatic ImpairmentRenal ImpairmentRheumatoid Arthritis,Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:
- No dosage adjustment is needed for patients with mild, moderate, or severe renal impairment.
Atopic Dermatitis:- For patients with severe renal impairment [estimated glomerular filtration rate (eGFR) 15 to < 30 mL/min/1.73m2] the recommended dosage of RINVOQ is 15 mg once daily[see Use in Specific Populations (8.6)].
- No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Ulcerative Colitis:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 8 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Crohn’s Disease:- For patients with severe renal impairment (eGFR 15 to < 30 mL/min/1.73m2), the recommended dosage of RINVOQ is:
•Induction:30 mg once daily for 12 weeks
•Maintenance:15 mg once daily - No dosage adjustment is needed for patients with mild or moderate renal impairment (eGFR ≥ 30 mL/min/1.73m2).
- RINVOQ is not recommended for use in patients with end stage renal disease (eGFR < 15 mL/min/1.73m2)[see Use in Specific Populations (8.6)].
Hepatic ImpairmentRINVOQ/RINVOQ LQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C)
[see Use in Specific Populations (8.7)].Rheumatoid Arthritis,Psoriatic Arthritis, Atopic Dermatitis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell Arteritis:No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B).
Ulcerative Colitis:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 8 weeks
- Maintenance:15 mg once daily
Crohn’s Disease:For patients with mild to moderate hepatic impairment (Child-Pugh A or B) the recommended dosage of RINVOQ is:
- Induction:30 mg once daily for 12 weeks
- Maintenance:15 mg once daily
)2.000000000000000e+0013Dosage Modifications Due to Drug InteractionsRheumatoid Arthritis, Psoriatic Arthritis,AnkylosingSpondylitis, Non-radiographic Axial Spondyloarthritis, pJIA, and Giant Cell ArteritisNo dosage adjustment is needed in patients receiving strong CYP3A4 inhibitors
[see Drug Interactions (7.1)].Atopic DermatitisThe recommended dosage of RINVOQ in patients receiving strong CYP3A4 inhibitors is 15 mg once daily
[see Drug Interactions (7.1)].Ulcerative ColitisThe recommended dosage of RINVOQ in patients with ulcerative colitis receiving strong CYP3A4 inhibitors
[see Drug Interactions(7.1)]:- Induction:30 mg once daily for 8 weeks
- Maintenance:15 mg once daily
Crohn’s DiseaseThe recommended dosage of RINVOQ in patients with Crohn’s disease receiving strong CYP3A4 inhibitors
[see Drug Interactions (7.1)]:- Induction:30 mg once daily for 12 weeks
- Maintenance:15 mg once daily
- The recommended dosage is based on body weight ()2.000000000000000e+0010Recommended Dosage inPolyarticular Juvenile Idiopathic Arthritis
The recommended dosage is based on body weight (Table 2).
Table 2: RINVOQ/RINVOQ LQ Dosage for Patients 2 years and older with pJIA Patient WeightRINVOQ LQRINVOQ10 kg to less than 20 kg3 mg (3 mL oral solution) twice dailyNot recommended20 kg to less than 30 kg4 mg (4 mL oral solution) twice dailyNot recommended30 kg and greater6 mg (6 mL oral solution) twice daily15 mg (one 15 mg tablet) once dailyRINVOQ LQ oral solution is not substitutable with RINVOQ extended-release tablets. Changes between RINVOQ LQ oral solution and RINVOQ extended-release tablets should be made by the health care provider.
- The recommended dosage of RINVOQ is 15 mg once daily in combination with a tapering course of corticosteroids. RINVOQ 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids ()2.11 Recommended Dosage in Giant Cell ArteritisThe recommended dosage of RINVOQ is 15 mg once daily in combination with a tapering course of corticosteroids.RINVOQ 15 mg once daily can be used as monotherapy following discontinuation of corticosteroids.
RINVOQ extended-release tablets:
- 15 mg upadacitinib: purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a15’ on one side.
- 30 mg upadacitinib: red, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a30’ on one side.
- 45 mg upadacitinib: yellow to mottled yellow, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with ‘a45’ on one side.
RINVOQ LQ oral solution:
- 1 mg/mL upadacitinib; clear, colorless to light yellow solution in bottle of 180 mL.
- Lactation: Advise not to breastfeed. ()8.2 LactationRisk Summary
There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk
(seeData).When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ/RINVOQ LQ, and for 6 days (approximately 10 half-lives) after the last dose.DataA single oral dose of 10 mg/kg radiolabeled upadacitinib was administered to lactating female Sprague-Dawley rats on post-partum days 7-8. Drug exposure was approximately 30-fold greater in milk than in maternal plasma based on AUC0-tvalues. Approximately 97% of drug-related material in milk was parent drug.
- Hepatic Impairment: RINVOQ/RINVOQ LQ is not recommended in patients with severe hepatic impairment. ()8.7 Hepatic Impairment
The use of RINVOQ/RINVOQ LQ has not been studied in patients with severe hepatic impairment (Child Pugh C), and is therefore not recommended
[see Dosage and Administration (2.12) and Clinical Pharmacology (12.3)].For patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pJIA, or giant cell arteritis, no dosage adjustment is needed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
For patients with ulcerative colitis or Crohn’s disease, the recommended dosage of RINVOQ for mild to moderate hepatic impairment is 30 mg once daily for induction and 15 mg once daily for maintenance
[see Dosage and Administration (2.12)].