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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 with immunosuppressants; screen for latent TB infection before and during tofacitinib tx; initiate anti-TB tx before tofacitinib tx; weigh risk/benefit in patients with chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx, including TB development in patients with negative TB test; D/C tofacitinib if serious infection develops
Mortality
higher rate of mortality, including sudden cardiovascular death, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with 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, including lymphoma and solid tumors, occurred in patients treated with JAK inhibitors for inflammatory conditions; higher rate of malignancies (excluding non-melanoma skin CA), lymphoma, and lung CA observed in RA patients treated with tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; incr. risk in current or past smokers
Major Adverse Cardiovascular Events
higher rate of major adverse cardiovascular events, including cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; incr. risk in current or past smokers; D/C tofacitinib in patients that experienced MI or stroke
Thrombosis
thrombosis, including PE, DVT, and arterial thrombosis occurred in patients treated with JAK inhibitors for inflammatory conditions; many adverse events were serious, sometimes fatal; higher rate of thrombosis observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor on tofacitinib 5 mg bid or 10 mg bid vs. TNF blockers; avoid tofacitinib in patients with thrombosis risk; D/C tofacitinib and promptly evaluate patients with thrombosis symptoms
Adult Dosing .
Dosage forms: ER TAB: 11 mg, 22 mg
Special Note
- [equivalency or interchangeability info]
- Info: tofacitinib IR products not interchangeable with ER product; do not substitute on a mg to mg basis
rheumatoid arthritis, moderate-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 with 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, moderate-severe
- [induction tx]
- Dose: 22 mg PO qd for at least 8wk; Info: may continue for up to 16wk based on response; D/C if no benefit after 16wk; may switch from 10 mg IR tab PO bid to 22 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
- [maintenance tx]
- Dose: 11 mg PO qd; Start: after at least 8wk induction tx; Info: use lowest effective dose; may consider 22 mg PO qd limited to shortest duration if response lost; may switch from 5 mg IR tab PO bid to 11 mg ER tab PO qd or 10 mg IR tab PO bid to 22 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
renal dosing
- [if usual dose 11 mg qd]
- CrCl <50: 5 mg IR qd; Info: ER tab cannot be cut, use IR tab for dose adjustments
- HD: 5 mg IR qd, on dialysis days administer 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]
- CrCl <50: 11 mg qd
- HD: 11 mg qd, on dialysis days administer after dialysis; no supplement; PD: not defined
hepatic dosing
- [if usual dose 11 mg qd]
- Child-Pugh Class B: 5 mg IR qd; Child-Pugh Class C: avoid use; Info: ER tab cannot be cut, use IR tab for dose adjustments
- [if usual dose 22 mg qd]
- Child-Pugh Class B: 11 mg qd; Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.