{"product_id":"generic-tofacitinib-tofadx-5","title":"TOFADX 5 (Tofacitinib)","description":"\u003cp\u003e\u003cstrong\u003eTofacitinib\u003c\/strong\u003e is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who are unable to take or did not respond to one or more tumor necrosis factor (TNF) inhibitor medication(s).\u003c\/p\u003e\u003ch3\u003eRheumatoid Arthritis\u003c\/h3\u003e\u003cp\u003eIndicated for moderate-to-severe active rheumatoid arthritis (RA) in adults with an inadequate response or intolerance to ≥1 tumor necrosis factor (TNF) blockers\u003c\/p\u003e\u003cp\u003eTofacitinib: 5 mg PO BID\u003c\/p\u003e\u003cp\u003eTofacitinib XR: 11 mg PO qDay\u003c\/p\u003e\u003ch3\u003ePsoriatic Arthritis\u003c\/h3\u003e\u003cp\u003eIndicated for active psoriatic arthritis in adults who have had an inadequate response or intolerance to ≥1 TNF blockers\u003c\/p\u003e\u003ch4\u003eRecommended dose in combination with nonbiologic DMARDs\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eTofacitinib: 5 mg PO BID\u003c\/li\u003e\n\u003cli\u003eTofacitinib XR: 11 mg PO qDay\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eUlcerative Colitis\u003c\/h3\u003e\u003cp\u003eIndicated for adults with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to ≥1 TNF blockers\u003c\/p\u003e\u003ch4\u003eTofacitinib\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eInduction\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e10 mg PO BID for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response\u003c\/li\u003e\n\u003cli\u003eIf needed, continue 10 mg BID for maximum of 16 weeks; discontinue after 16 weeks if adequate therapeutic benefit not achieved\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eMaintenance\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e5 mg PO BID; may consider 10 mg BID (limited to shorter duration) in patients with loss of response during maintenance treatment\u003c\/li\u003e\n\u003cli\u003eUse the lowest effective dose needed to maintain response\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eTofacitinib XR\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eInduction\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e22 mg PO qDay for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response\u003c\/li\u003e\n\u003cli\u003eIf needed, continue 22 mg qDay for maximum of 16 weeks; discontinue after 16 weeks if adequate therapeutic benefit not achieved\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eMaintenance\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003e11 mg PO qDay; may consider 22 mg qDay (limited to shorter duration) in patients with loss of response during maintenance treatment\u003c\/li\u003e\n\u003cli\u003eUse the lowest effective dose needed to maintain response\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eAnkylosing Spondylitis\u003c\/h3\u003e\u003cp\u003eIndicated for active ankylosing spondylitis (AS) in adults who have an inadequate response or are intolerant to ≥1 TNF blockers\u003c\/p\u003e\u003cp\u003eTofacitinib: 5 mg PO BID\u003c\/p\u003e\u003cp\u003eTofacitinib XR: 11 mg PO qDay\u003c\/p\u003e\u003ch3\u003eDosage Modifications\u003c\/h3\u003e\u003ch4\u003eStrong CYP3A4 inhibitors OR moderate CYP3A4 inhibitors with strong CYP2C19 inhibitors\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eRA, PsA, or AS\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eTofacitinib: Not to exceed 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eTofacitinib XR: Switch to Tofacitinib 5 mg qDay\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eUC\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eTofacitinib: If taking 10 mg BID, reduce to 5 mg BID; if taking 5 mg BID, reduce to 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eTofacitinib XR: If taking 22 mg qDay, reduce to 11 mg qDay; if taking 11 mg qDay, switch to Xeljanz 5 mg qDay\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eLymphopenia\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eRA, PsA, AS, or UC\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eLymphocytes \u0026lt;500 cells\/mm\u003csup\u003e3\u003c\/sup\u003e: Confirmed by repeat testing; discontinue until infection controlled\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eANC 500-1000 cells\/mm³\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eRA, PsA, or AS\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eInterrupt dosing for persistent decreases; when ANC \u0026gt;1000\/mm\u003csup\u003e3\u003c\/sup\u003e, resume dose at Tofacitinib 5 mg BID or Tofacitinib XR 11 mg qDay\u003c\/li\u003e\n\u003cli\u003eANC \u0026lt;500 cells\/mm\u003csup\u003e3\u003c\/sup\u003e: Confirmed by repeat testing; discontinue\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eUC\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eTofacitinib: If taking 10 mg BID, reduce to 5 mg BID; when ANC \u0026gt;1000, increase to 10 mg BID based on clinical response; if taking 5 mg BID, interrupt dosing; when ANC \u0026gt;1000, resume 5 mg BID\u003c\/li\u003e\n\u003cli\u003eTofacitinib XR: If taking 22 mg qDay, reduce to 11 mg qDay when ANC \u0026gt;1000, increase to 22 mg qDay based on clinical response; if taking 11 mg qDay, interrupt dosing; when ANC \u0026gt;1000, resume 11 mg qDay\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eAnemia\u003c\/h4\u003e\u003cul\u003e\u003cli\u003e\n\u003ch5\u003eRA, PsA, AS, or UC\u003c\/h5\u003e\n\u003cul\u003e\u003cli\u003eHgb \u0026gt;2 g\/dL decrease or level \u0026lt;8.0 g\/dL: Confirmed by repeat testing; interrupt treatment until Hgb levels have normalized\u003c\/li\u003e\u003c\/ul\u003e\n\u003c\/li\u003e\u003c\/ul\u003e\u003ch4\u003eRenal impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003e\n\u003ch5\u003eRA, PsA, or AS\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eMild: No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eModerate-to-severe (Tofacitinib): Not to exceed 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eModerate-to-severe (Tofacitinib XR): Switch to Xeljanz 5 mg qDay\u003c\/li\u003e\n\u003cli\u003ePatients undergoing hemodialysis: Administer dose after dialysis session on dialysis days; if dose administered before dialysis session, supplemental doses are not recommended\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eUC\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eMild (Tofacitinib and Tofacitinib XR): No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eModerate-to-severe (Tofacitinib): If taking 10 mg BID, reduce to 5 mg BID; if taking 5 mg BID, reduce to 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eModerate-to-severe (Tofacitinib XR): If taking 22 mg qDay, reduce to 11 mg qDay; if taking 11 mg qDay, switch to Xeljanz 5 mg qDay\u003c\/li\u003e\n\u003cli\u003ePatients undergoing hemodialysis: Administer dose after dialysis session on dialysis days; if dose administered before dialysis session, supplemental doses are not recommended\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eHepatic impairment\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eSafety and efficacy have not been studied in patients with positive hepatitis B virus or hepatitis C virus serology (Add to adult)\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eRA, PsA, or AS\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eMild (Xeljanz and Xeljanz XR): No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eModerate (Tofacitinib): Not to exceed 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eModerate (Tofacitinib XR): Switch to Xeljanz 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eSevere (Tofacitinib and Tofacitinib XR): Not recommended\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003cli\u003e\n\u003ch5\u003eUC\u003c\/h5\u003e\n\u003cul\u003e\n\u003cli\u003eMild (Tofacitinib and Tofacitinib XR): No dosage adjustment required\u003c\/li\u003e\n\u003cli\u003eModerate (Tofacitinib): If taking 10 mg BID, reduce to 5 mg BID; if taking 5 mg BID, reduce to 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eModerate (Tofacitinib XR): If taking 22 mg qDay, reduce to 11 mg qDay; if taking 11 mg qDay, switch to Tofacitinib 5 mg qDay\u003c\/li\u003e\n\u003cli\u003eSevere (Tofacitinib and Tofacitinib XR): Not recommended\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eDosing Considerations\u003c\/h3\u003e\u003cp\u003eHigher incidence of infections in geriatric patients; use with caution\u003c\/p\u003e\u003ch4\u003eDo not initiate if\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eAbsolute lymphocyte count \u0026lt;500 cells\/mm\u003csup\u003e3\u003c\/sup\u003e OR\u003c\/li\u003e\n\u003cli\u003eANC \u0026lt;1000 cells\/mm\u003csup\u003e3\u003c\/sup\u003e OR\u003c\/li\u003e\n\u003cli\u003eHgb \u0026lt;9 g\/dL\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch4\u003eLimitations of use\u003c\/h4\u003e\u003cul\u003e\n\u003cli\u003eRA, PsA, AS: Use in combination with biologic disease-modifying antirheumatic drugs (DMARDS) or potent immunosuppressants (eg, azathioprine, cyclosporine) is not recommended\u003c\/li\u003e\n\u003cli\u003eUC: Use in combination with biologic therapies or potent immunosuppressants (eg, azathioprine, cyclosporine) is not recommended\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"BIGBEAR Pharma, Laos PDR","offers":[{"title":"Default Title","offer_id":44797950394411,"sku":"RL1520230918","price":0.0,"currency_code":"AMD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0701\/3528\/3755\/files\/2023-09-1762-1.jpg?v=1787022152","url":"https:\/\/xomeds.com\/products\/generic-tofacitinib-tofadx-5","provider":"XOMEDS","version":"1.0","type":"link"}