Rinvoq

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.

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.

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.

1.4 Ulcerative Colitis

RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis 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, biological therapies for ulcerative colitis, or with potent immunosuppressants such as azathioprine and cyclosporine.

1.5 Crohn’s Disease

RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease 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, biological therapies for Crohn’s disease, or with potent immunosuppressants such as azathioprine and cyclosporine.

1.6 Ankylosing 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.

1.7 Non-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.

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.

1.9 Giant Cell Arteritis

RINVOQ 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.

2.1 Recommended 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)].

2.2 Important 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 [see Instructions for Use].

● RINVOQ LQ is dosed twice daily [see Dosage and Administration ( 2.4, 2.10)].

2.3 Recommended Dosage in Rheumatoid Arthritis 

The recommended dosage of RINVOQ is 15 mg once daily.

2.4 Recommended Dosage in Psoriatic Arthritis 

Pediatric Patients 2 to Less Than 18 Years of Age

The recommended dosage is based on body weight .

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 health care provider.

Adults 18 Years of Age and Older

The recommended dosage of RINVOQ is 15 mg once daily.

2.5 Recommended Dosage in Atopic Dermatitis

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 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 Older

The recommended dosage of RINVOQ is 15 mg once daily.

2.6 Recommended Dosage in Ulcerative Colitis

Adult Patients: Induction

The recommended induction dosage of RINVOQ is 45 mg once daily for 8 weeks.

Adult Patients: Maintenance

The 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.

2.7 Recommended Dosage in Crohn’s Disease

Adult Patients: Induction

The recommended induction dosage of RINVOQ is 45 mg once daily for 12 weeks.

Adult Patients: Maintenance

The 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.

2.8 Recommended Dosage in Ankylosing Spondylitis

The recommended dosage of RINVOQ is 15 mg once daily.

2.9 Recommended Dosage in Non-radiographic Axial Spondyloarthritis

The recommended dosage of RINVOQ is 15 mg once daily.

2.10 Recommended Dosage in Polyarticular Juvenile Idiopathic Arthritis 

The recommended dosage is based on body weight (Table 2).

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 health care provider.

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.

2.12 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:

● 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 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:

• 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

2.13 Dosage Modifications Due to Drug Interactions

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing 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)]:

• Induction: 30 mg once daily for 8 weeks
  
• Maintenance: 15 mg once daily

Crohn’s Disease

The 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

2.14 Dosage Interruption

Infections

If 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 Abnormalities

Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 3 [see Warnings and Precautions ( 5.8)].

8.1 Pregnancy

Pregnancy Surveillance Program

There is a pregnancy surveillance program for RINVOQ/RINVOQ LQ that monitors pregnancy outcomes in women exposed to RINVOQ/RINVOQ LQ. If RINVOQ/RINVOQ LQ exposure occurs during pregnancy, healthcare providers or patients should report the pregnancy by calling 1-800-633-9110.

Risk Summary

Available data from the pharmacovigilance safety database and postmarketing case reports on use of RINVOQ in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, RINVOQ/RINVOQ LQ has the potential to adversely affect a developing fetus. Advise patients of reproductive potential and pregnant patients of the potential risk to the fetus. 

In animal embryo-fetal development studies, oral upadacitinib administration to pregnant rats and rabbits at exposures equal to or greater than approximately 1.6 and 15 times the 15 mg tablet dose, 0.8 and 7.6 times the 30 mg tablet dose, and 0.6 and 5.6 times the maximum recommended human dose (MRHD) of 45 mg (on an AUC basis) resulted in dose-related increases in skeletal malformations (rats only), an increased incidence of cardiovascular malformations (rabbits only), increased post-implantation loss (rabbits only), and decreased fetal body weights in both rats and rabbits. No developmental toxicity was observed in pregnant rats and rabbits treated with oral upadacitinib during organogenesis at exposures approximately 0.29 and 2.2 times the 15 mg dose, 0.15 times and 1.1 times the 30 mg dose, and at 0.11 and 0.82 times the MRHD (on an AUC basis). In a pre- and post-natal development study in pregnant female rats, oral upadacitinib administration at exposures approximately 3 times the 15 mg dose, 1.4 times the 30 mg dose, and the same as the MRHD (on an AUC basis) resulted in no maternal or developmental toxicity (see Data). 

The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages are 2-4% and 15-20%, respectively.

Clinical Considerations 

Disease-Associated Maternal and/or Embryo/Fetal Risk

Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis or inflammatory bowel disease. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.

Data 

Animal Data

In an oral embryo-fetal development study, pregnant rats received upadacitinib at doses of 5, 25, and 75 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Upadacitinib was teratogenic (skeletal malformations that consisted of misshapen humerus and bent scapula) at exposures equal to or greater than approximately 1.7 times the 15 mg tablet dose, 0.9 times the 30 mg tablet dose, and 0.6 times the MRHD (on an AUC basis at maternal oral doses of 5 mg/kg/day and higher). Additional skeletal malformations (bent forelimbs/hindlimbs and rib/vertebral defects) and decreased fetal body weights were observed in the absence of maternal toxicity at an exposure approximately 84 times the 15 mg dose, 43 times the 30 mg dose, and 31 times the MRHD (on an AUC basis at a maternal oral dose of 75 mg/kg/day). 

In a second oral embryo-fetal development study, pregnant rats received upadacitinib at doses of 1.5 and 4 mg/kg/day during the period of organogenesis from gestation day 6 to 17. Upadacitinib was teratogenic (skeletal malformations that included bent humerus and scapula) at exposures approximately 1.6 times the 15 mg dose, 0.8 times the 30 mg dose, and 0.6 times the MRHD (on an AUC basis at maternal oral doses of 4 mg/kg/day). No developmental toxicity was observed in rats at an exposure approximately 0.29 times the 15 mg tablet dose, 0.15 times the 30 mg tablet dose, and 0.11 times the MRHD (on an AUC basis at a maternal oral dose of 1.5 mg/kg/day).

In an oral embryo-fetal developmental study, pregnant rabbits received upadacitinib at doses of 2.5, 10, and 25 mg/kg/day during the period of organogenesis from gestation day 7 to 19. Embryolethality, decreased fetal body weights, and cardiovascular malformations were observed in the presence of maternal toxicity at an exposure approximately 15 times the 15 mg tablet dose, 7.6 times the 30 mg tablet dose, and 5.6 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). Embryolethality consisted of increased post-implantation loss that was due to elevated incidences of both total and early resorptions. No developmental toxicity was observed in rabbits at an exposure approximately 2.2 times the 15 mg tablet dose, 1.1 times the 30 mg tablet dose, and 0.82 times the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).

In an oral pre- and post-natal development study, pregnant female rats received upadacitinib at doses of 2.5, 5, and 10 mg/kg/day from gestation day 6 through lactation day 20. No maternal or developmental toxicity was observed in either mothers or offspring, respectively, at an exposure approximately 3 times the 15 mg tablet dose, 1.4 times the 30 mg tablet dose, and at approximately the same exposure as the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day).

8.2 Lactation

Risk 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 (see Data). 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. 

Data

A 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-t values. Approximately 97% of drug-related material in milk was parent drug.

8.3 Females and Males of Reproductive Potential

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior to starting treatment with RINVOQ/RINVOQ LQ [see Use in Specific Populations ( 8.1)].

Contraception 

Females

Based on animal studies, upadacitinib may cause embryo-fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1)]. Advise female patients of reproductive potential to use effective contraception during treatment with RINVOQ/RINVOQ LQ and for 4 weeks after the final dose.

8.4 Pediatric Use

Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Ulcerative Colitis, and Crohn’s Disease

The safety and effectiveness of RINVOQ/RINVOQ LQ in pediatric patients with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s disease have not been established.

Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis

The safety and effectiveness of RINVOQ/RINVOQ LQ in pediatric patients 2 to less than 18 years of age with pJIA and psoriatic arthritis have been established.

The use of RINVOQ/RINVOQ LQ in these age groups is supported by evidence from well-controlled studies of RINVOQ in adults with rheumatoid arthritis and psoriatic arthritis, pharmacokinetic data from adult patients with rheumatoid arthritis and psoriatic arthritis and 51 pediatric patients with JIA with active polyarthritis, and safety data from 83 pediatric patients 2 to < 18 years of age with JIA with active polyarthritis. Upadacitinib plasma exposures in pediatric patients with pJIA and psoriatic arthritis at the recommended dosage are predicted to be comparable to those observed in adults with rheumatoid arthritis and psoriatic arthritis based on population pharmacokinetic modeling and simulation [see Dosage and Administration ( 2.4,  2.10), Adverse Reactions ( 6.1), Clinical Pharmacology ( 12.3) and Clinical Studies ( 14.8)].

The safety and effectiveness of RINVOQ/RINVOQ LQ in pediatric patients less than 2 years of age with pJIA or psoriatic arthritis have not been established.

Atopic Dermatitis

The safety and effectiveness of RINVOQ in pediatric patients 12 years of age and older weighing at least 40 kg with atopic dermatitis have been established. A total of 344 pediatric patients aged 12 to 17 years with moderate to severe atopic dermatitis were randomized across three trials (AD-1, AD-2 and AD-3) to receive either RINVOQ 15 mg (N=114) or 30 mg (N=114) or matching placebo (N=116) in monotherapy or combination with topical corticosteroids. Efficacy was consistent between the pediatric patients and adults [see Clinical Studies ( 14.3)]. The adverse reaction profile in the pediatric patients was similar to the adults [see Adverse Reactions ( 6.1)]. 

The safety and effectiveness of RINVOQ in pediatric patients less than 12 years of age with atopic dermatitis have not been established.

The safety and effectiveness of RINVOQ LQ in pediatric patients with atopic dermatitis have not been established.

8.5 Geriatric Use

Rheumatoid Arthritis and Psoriatic Arthritis

Of the 4381 patients treated in the five clinical trials, a total of 906 rheumatoid arthritis patients were 65 years of age or older, including 146 patients 75 years and older. Of the 1827 patients treated in the two psoriatic arthritis Phase 3 clinical trials, a total of 274 patients were 65 years of age or older, including 34 patients 75 years and older. No differences in effectiveness were observed between these patients and younger patients; however, there was a higher rate of overall adverse events, including serious infections, in patients 65 years of age and older. 

Atopic Dermatitis

Of the 2583 patients treated in the three Phase 3 clinical trials, a total of 120 patients with atopic dermatitis were 65 years of age or older, including 6 patients 75 years of age. No differences in effectiveness were observed between these patients and younger patients; however, there was a higher rate of serious infections and malignancies in those patients 65 years of age or older in the 30 mg dosing group in the long-term trials.

Ulcerative Colitis

Of the 1097 patients treated in the controlled clinical trials, a total of 95 patients with ulcerative colitis were 65 years and older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ulcerative colitis to determine whether they respond differently from younger adult patients.

Crohn’s Disease

Of the 1021 patients who were treated in the controlled induction clinical trials, a total of 39 patients with Crohn’s disease were 65 years of age or older, and no patients were 75 years of age or older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with Crohn’s disease to determine whether they respond differently from younger adult patients.

Ankylosing Spondylitis

Of the 607 patients treated in the controlled clinical trials, a total of 32 patients with ankylosing spondylitis were 65 years and older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ankylosing spondylitis to determine whether they respond differently from younger adult patients.

Non-radiographic Axial Spondyloarthritis

Of the 313 patients treated in a phase 3 clinical trial, a total of 9 patients with non-radiographic axial spondyloarthritis were 65 years and older. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with non-radiographic axial spondyloarthritis to determine whether they respond differently from younger adult patients.

8.6 Renal Impairment

For patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pJIA, or giant cell arteritis no dosage adjustment is needed in patients with mild (eGFR 60 to < 90 mL/min/1.73 m2), moderate (eGFR 30 to < 60 mL/min/1.73 m2), or severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m2).

For patients with atopic dermatitis, the maximum recommended dosage of RINVOQ is 15 mg once daily for patients with severe renal impairment. No dosage adjustment is needed in patients with mild or moderate renal impairment.

For patients with ulcerative colitis or Crohn’s disease, the recommended dosage of RINVOQ for severe renal impairment is 30 mg once daily for induction and 15 mg once daily for maintenance. No dosage adjustment is needed in patients with mild or moderate renal impairment [see Dosage and Administration ( 2.12)].  

RINVOQ/RINVOQ LQ has not been studied in patients with end stage renal disease (eGFR <15 mL/min/1.73m2). Use in patients with atopic dermatitis, ulcerative colitis, or Crohn’s disease with end stage renal disease is not recommended [see Clinical Pharmacology ( 12.3)]. 

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)].