Source: FDA, National Drug Code (US) Revision Year: 2020
RINVOQ (upadacitinib) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Limitation of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.
The recommended oral dose of RINVOQ is 15 mg once daily with or without food [see Clinical Pharmacology (12.3)].
RINVOQ may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
RINVOQ treatment should be interrupted if a patient develops a serious infection until the infection is controlled [see Warnings and Precautions (5.1)].
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1.
Table 1. Recommended Dose Interruptions for Laboratory Abnormalities:
| Laboratory measure | Action |
|---|---|
| Absolute Neutrophil Count (ANC) | Treatment should be interrupted if ANC is less than 1000 cells/mm 3 and may be restarted once ANC return above this value |
| Absolute Lymphocyte Count (ALC) | Treatment should be interrupted if ALC is less than 500 cells/mm³ and may be restarted once ALC return above this value |
| Hemoglobin (Hb) | Treatment should be interrupted if Hb is less than 8 g/dL and may be restarted once Hb return above this value |
| Hepatic transaminases | Treatment should be interrupted if drug-induced liver injury is suspected |
Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to 60 mg extended-release once daily. Adverse events were comparable to those seen at lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.
Store at 2˚C to 25˚C (36˚F to 77˚F).
Store in the original bottle in order to protect from moisture.
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