What are the FDA‑approved indications and recommended dosing for upadacitinib (Rinvoq) in adults and children?

FDA-Approved Indications of Upadacitinib (Rinvoq)

Upadacitinib is FDA-approved for multiple immune-mediated inflammatory conditions in both adults and children, with specific dosing that varies by indication and patient age. 1

FDA-Approved Indications in Adults

Rheumatologic Conditions

• Rheumatoid Arthritis: For adults with moderately to severely active disease who have had inadequate response or intolerance to methotrexate 1

  • Dosing: 15 mg once daily 1

• Psoriatic Arthritis: For adults with active disease who have had inadequate response or intolerance to one or more TNF blockers 1

  • Dosing: 15 mg once daily 1

• Ankylosing Spondylitis: For adults with active disease who have had inadequate response or intolerance to one or more TNF blockers 1

  • Dosing: 15 mg once daily 1

• Non-radiographic Axial Spondyloarthritis: For adults with active disease with objective signs of inflammation who have had inadequate response or intolerance to TNF blocker therapy 1

  • Dosing: 15 mg once daily 1

Dermatologic Conditions

• Atopic Dermatitis: For adults and adolescents ≥12 years with moderate-to-severe disease who have failed other systemic therapies (immunosuppressants, corticosteroids, antimetabolites, injectable biologics) or when they are inadvisable 2, 1
  • Adults <65 years: Initiate with 15 mg once daily; may increase to 30 mg once daily if inadequate response 1
  • Adults ≥65 years: 15 mg once daily only 1
  • Adolescents ≥12 years weighing ≥40 kg: Same as adults <65 years 1
  • The 30 mg dose demonstrates the highest efficacy among all available AD treatments and is superior to dupilumab in head-to-head trials 2

Gastrointestinal Conditions

• Ulcerative Colitis: For adults with moderately to severely active disease who have had inadequate response or intolerance to one or more TNF blockers 2, 1

  • Induction: 45 mg once daily for 8 weeks 1
  • Maintenance: 15 mg once daily; may consider 30 mg once daily for refractory, severe, or extensive disease 1

• Crohn's Disease: For adults with moderately to severely active disease who have had inadequate response or intolerance to one or more TNF blockers 1

  • Induction: 45 mg once daily for 12 weeks 1
  • Maintenance: 15 mg once daily; may consider 30 mg once daily for refractory, severe, or extensive disease 1

FDA-Approved Indications in Pediatric Patients

Rheumatologic Conditions in Children

• Polyarticular Juvenile Idiopathic Arthritis: For patients ≥2 years with active disease who have had inadequate response or intolerance to one or more TNF blockers 1, 3

  • Weight-tiered dosing: Based on body weight using either extended-release tablets (once daily) or oral solution (twice daily) 1, 3

• Psoriatic Arthritis: For patients ≥2 years weighing ≥10 kg with active disease who have had inadequate response or intolerance to one or more TNF blockers 1, 3

  • Weight-tiered dosing: Based on body weight 1

Critical Positioning and Limitations of Use

Upadacitinib is NOT first-line therapy for most indications 2

• For atopic dermatitis: Reserved for patients who have failed conventional systemic treatments 2
• For rheumatologic and GI conditions: Reserved for TNF blocker failures or intolerance 1
• JAK inhibitors have restricted use in advanced therapy-naïve patients per FDA labeling 2

Contraindicated Combinations

Do not use upadacitinib with: 1

• Other JAK inhibitors
• Biologic immunomodulators or biologic DMARDs
• Potent immunosuppressants (azathioprine, cyclosporine)

Dose Modifications for Special Populations

Renal Impairment

• Severe renal impairment (CrCl <30 mL/min): Maximum dose 15 mg once daily 1

Hepatic Impairment

• Severe hepatic impairment (Child-Pugh C): Contraindicated 1

Pre-Treatment Requirements

Before initiating upadacitinib, complete the following: 2, 4

• Test for latent tuberculosis and treat if positive
• Administer all needed live vaccines (particularly herpes zoster vaccine for older patients)
• Baseline laboratory testing: CBC with differential, liver enzymes, lipid profile
• Test for viral hepatitis B and C
• Pregnancy testing in women of reproductive potential

Laboratory Monitoring Schedule

• Baseline: CBC with differential, liver enzymes, renal function, lipids 2
• After initiation: Lipids at 12 weeks 2
• Ongoing: Per routine management 2

Black Box Warnings and Safety Considerations

The FDA has applied class-wide warnings for all JAK inhibitors based on data from tofacitinib in rheumatoid arthritis patients ≥50 years with cardiovascular risk factors: 2, 4

• Increased risk of major adverse cardiovascular events
• Increased risk of malignancies
• Increased risk of venous thromboembolism
• Increased risk of death

Exercise particular caution in patients ≥50 years with cardiovascular risk factors (current/previous smoking, history of cardiovascular disease, history of cancer) 4, 5

Patients ≥65 years with cardiovascular risk factors should avoid upadacitinib unless no alternatives exist 5