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Xeljanz XR
tofacitinib
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 tofacitinib tx; initiate anti-TB tx before tofacitinib 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 tofacitinib 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/ tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers in a large, randomized, post-marketing study; tofacitinib 10 mg bid or 22 mg ER qd not recommended for tx of RA or psoriatic arthritis
Malignancies
malignancies, incl. lymphoma and solid tumors, occurred in pts treated w/ JAK inhibitors for inflammatory conditions; higher rate of malignancies (excluding non-melanoma skin CA), lymphoma, and lung CA observed in RA pts treated w/ tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; incr. risk in current or past smokers; incr. rate of EBV-assoc. post-transplant lymphoproliferative dz observed in renal transplant pts receiving concomitant immunosuppressive meds
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/ tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; incr. risk in current or past smokers; D/C tofacitinib in pts that experienced MI or stroke
Thrombosis
thrombosis, incl. PE, DVT, and arterial thrombosis occurred in pts treated w/ 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 tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; avoid tofacitinib in pts w/ thrombosis risk; D/C tofacitinib and promptly evaluate pts w/ thrombosis sx
Adult Dosing .
Dosage forms: ER TAB: 11 mg, 22 mg
Special Note
- [formulation clarification]
- Info: not interchangeable w/ solution; do not substitute on a mg per mg basis
rheumatoid arthritis, mod-severe
- [11 mg PO qd]
- Info: may switch from 5 mg IR tab PO bid to 11 mg ER tab PO qd starting day after last IR dose; see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
psoriatic arthritis
- [11 mg PO qd]
- Info: use w/ non-biologic DMARDs; may switch from 5 mg IR tab PO bid to 11 mg ER tab PO qd starting day after last IR dose; see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
ankylosing spondylitis
- [11 mg PO qd]
- Info: may switch from 5 mg IR tab PO bid to 11 mg ER tab PO qd starting day after last IR dose; see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
ulcerative colitis, mod-severe
- [11 mg PO qd]
- Start: 22 mg PO qd for at least 8wk, then 11 mg PO qd; Info: use lowest effective dose, shortest effective tx duration; may cont. 22 mg PO qd for up to 16wk total if initial response lost; may switch from 10 mg IR tab PO bid to 22 mg ER tab PO qd or 5 mg IR tab PO bid to 11 mg ER tab PO qd starting day after last IR dose; D/C if no benefit at 22 mg PO qd x16wk; see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
renal dosing
- [if usual dose 11 mg qd]
- moderate-severe impairment: 5 mg qd; Info: ER tab cannot be cut, use IR tab for dose adjustments
- HD: 5 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined; Info: ER tab cannot be cut, use IR tab for dose adjustments
- [if usual dose 22 mg qd]
- moderate-severe impairment: 11 mg qd
- HD: 11 mg qd, on dialysis days admin. after dialysis; no supplement; PD: not defined
hepatic dosing
- [if usual dose 11 mg qd]
- moderate impairment: 5 mg qd; severe impairment: avoid use; Info: ER tab cannot be cut, use IR tab for dose adjustments
- [if usual dose 22 mg qd]
- moderate impairment: 11 mg qd; severe impairment: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.