Rinvoq

UPADACITINIB

Manufacturer: AbbVie Inc.

Score: 144.0

Quick Summary

Rinvoq (Upadacitinib) is a Janus kinase (JAK) inhibitor used to treat various conditions, including rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. It works by preventing the phosphorylation and activation of signal transducers and activators of transcription (STATs), which modulate intracellular activity, including gene expression. The recommended dosage varies depending on the condition being treated, with most conditions requiring 15 mg once daily. Important safety information includes warnings about serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. Contraindications include known hypersensitivity to upadacitinib or any of its excipients. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Rheumatoid arthritis
Psoriatic arthritis
Atopic dermatitis
Ulcerative colitis
Crohn's disease
Ankylosing spondylitis
Non-radiographic axial spondyloarthritis

Important Safety Information

Warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

Contraindications

Known hypersensitivity to upadacitinib or any of its excipients

Adverse Reactions

Upper respiratory tract infections
Herpes zoster
Herpes simplex
Bronchitis
Nausea
Cough
Pyrexia
Acne
Headache

Dosing Recommendations

General Guidance

Dosage adjustments may be necessary for patients with renal or hepatic impairment

Rheumatoid arthritis

Adult Dose

15 mg once daily

Pediatric Dose

Not recommended

Psoriatic arthritis

Adult Dose

15 mg once daily

Pediatric Dose

10 kg to less than 20 kg: 3 mg (3 mL oral solution) twice daily

Atopic dermatitis

Adult Dose

15 mg once daily

Pediatric Dose

12 years of age and older weighing at least 40 kg: 15 mg once daily

Special Population Considerations

Pregnancy

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

Nursing Mothers

It is not known whether upadacitinib is present in human milk

Pediatric Use

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

Geriatric Use

No differences in effectiveness were observed between geriatric 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