Rinvoq FDA Approval History
Last updated by Judith Stewart, BPharm on May 19, 2023.
FDA Approved: Yes (First approved August 16, 2019)
Brand name: Rinvoq
Generic name: upadacitinib
Dosage form: Extended-Release Tablets
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Crohn's Disease, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
- Rinvoq works by blocking the activity of Janus kinase enzymes in the JAK-STAT signaling pathway, an intracellular pathway that plays a major role in the release of the pro-inflammatory cytokines that stimulate inflammation in rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
- 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
- adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
- 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
- adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
- adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers
- adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
- adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
- Rinvoq extended-release tablets are administered orally once daily.
- Rinvoq carries a boxed warning for the risk of serious infections, an increased rate of all-cause mortality, malignancies, adverse cardiovascular events, and thrombosis. Warnings and precautions associated with Rinvoq include serious infections, hypersensitivity reactions, gastrointestinal (GI) perforations, laboratory abnormalities, and embryo-fetal toxicity.
- Adverse reactions in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and nonradiographic axial spondyloarthritis patients include upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, and acne.
Adverse reactions in atopic dermatitis patients include upper respiratory tract infections, acne, herpes simplex, headache, blood creatine phosphokinase increased, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.
Adverse reactions in ulcerative colitis patients include upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, and rash.
Adverse reactions in Crohn’s disease patients include upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.
Development timeline for Rinvoq
Further information
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