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Rinvoq LQ
upadacitinib
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; most infections occur in combo w/ immunosuppressants; screen for latent TB infection before and during upadacitinib tx; initiate anti-TB tx before upadacitinib tx; weigh risk/benefit in pts w/ chronic or recurrent infection; monitor closely for infection s/sx during and after tx, incl. TB development in pts w/ negative TB test; D/C upadacitinib if serious infection develops
Mortality
higher rate of mortality, incl. sudden cardiovascular death, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study
Malignancies
lymphoma and other malignancies observed w/ upadacitinib; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA pts treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers
Major Adverse Cardiovascular Events
higher rate of major adverse cardiovascular events, incl. cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C upadacitinib in pts that experienced MI or stroke
Thrombosis
thrombosis, incl. DVT, PE, and arterial thrombosis occurred in pts treated w/ upadacitinib and other JAK inhibitors for inflammatory conditions; many adverse events were serious, sometimes fatal; higher rate of thrombosis observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid upadacitinib in pts w/ thrombosis risk; D/C upadacitinib and promptly evaluate pts w/ thrombosis sx
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: SOL: 1 mg per mL
Special Note
- [formulation clarification]
- Info: Rinvoq LQ not interchangeable w/ Rinvoq; do not substitute on a mg to mg basis
psoriatic arthritis
- [2 yo and older, 10-19.9 kg]
- Dose: 3 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
- [2 yo and older, 20-29.9 kg]
- Dose: 4 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
- [2 yo and older, >30 kg]
- Dose: 6 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
polyarticular juvenile idiopathic arthritis
- [2 yo and older, 10-19.9 kg]
- Dose: 3 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
- [2 yo and older, 20-29.9 kg]
- Dose: 4 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
- [2 yo and older, >30 kg]
- Dose: 6 mg PO bid; Info: see pkg insert for toxicity-related dose adjustments
renal dosing
- [see below]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use