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Rheumatoid Arthritis
,
Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
Psoriatic Arthritis
Atopic Dermatitis
Ulcerative Colitis
Crohn’s
D
isease
Polyarticular Juvenile Idiopathic Arthritis
Giant Cell Arteritis
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Rinvoq Prescribing Information
SERIOUS INFECTIONS
Patients treated with RINVOQ
/RINVOQ LQ
are at increased risk for developing serious infections that may lead to hospitalization or death
[see Warnings and Precautions (
5.1
), Adverse Reactions (
6.1
)].
Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt RINVOQ
/RINVOQ LQ
until the infection is controlled.
Reported infections include:
- 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.
The risks and benefits of treatment with RINVOQ
/RINVOQ LQ
should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ
/RINVOQ LQ
, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy
[see Warnings and Precautions (
5.1
)].
MORTALITY
In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor
[see Warnings and Precautions (
5.2
)]
.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with RINVOQ
. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk
[see Warnings and Precautions (
5.3
)]
.
MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ
/RINVOQ LQ
in patients that have experienced a myocardial infarction or stroke
[see Warnings and Precautions (
5.4
)]
.
THROMBOSIS
Thrombos
e
s, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis
,
have occurred in patients treated
for inflammatory conditions
with J
AK
inhibitors
, including RINVOQ
. Many of these adverse events were serious and some resulted in death.
In RA
patients
50 years of age and older with
at
least one cardiovascular
risk
factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid RINVOQ
/RINVOQ LQ
in patients at risk.
Patients with symptoms of thrombosis should
discontinue RINVOQ
/RINVOQ LQ
and
be promptly evaluated
[see Warnings and Precautions (
5.5
)]
.
| Boxed Warning | 4/2025 |
| Indications and Usage | 4/2024 |
| Indications and Usage | 4/2025 |
| Dosage and Administration | 4/2024 |
| Dosage and Administration | 4/2025 |
| Warnings and Precautions | 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. 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 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. 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. - 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. - RINVOQ is indicated for the treatment of adults 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. - RINVOQ is indicated for the treatment of adults 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. - 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. - 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. - 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. 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 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.
- 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
- 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.
Rheumatoid Arthritis
,
Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis
- Adults:The recommended dosage of RINVOQ is 15 mg once daily.
Psoriatic Arthritis
- Pediatric Patients 2 to less than 18 Years of Age Weighing at Least 10 kg:The recommended dosage is based on body weight
- Adults:The recommended dosage of RINVOQ is 15 mg once daily.
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 orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily.
- Adults65 Years of Ageand Older: Recommended dosage of RINVOQ is 15 mg once daily.
- SevereRenal Impairment: Recommended dosage of RINVOQ is 15 mg once daily.
Ulcerative Colitis
- 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.
- See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions.
Crohn’s
D
isease
- 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.
- See the Full Prescribing Information for the recommended dosage in patients with renal or hepatic impairment and for dosage modification due to drug interactions.
Polyarticular Juvenile Idiopathic Arthritis
- The recommended dosage is based on body weight
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
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.
- Hepatic Impairment: RINVOQ/RINVOQ LQ is not recommended in patients with severe hepatic impairment.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available