COMPOSITION
Tofacinix Tablet: Each film coated tablet contains TofacitinibCitrate INN equivalent to Tofacitinib 5 mg.
Therapeutic Class: Antirheumatic drug.
INDICATIONS
Tofacitinib is indicated for the treatment of adult patients withmoderately to severely active rheumatoid arthritis who have hadan inadequate response or intolerance to methotrexate. It may beused as monotherapy or in combination with methotrexate orother nonbiologic disease-modifying antirheumatic drugs(DMARDs).
- Tofacitinib is 5 mg twice daily
- Tofacitinb is given orally with or without food.
- Limitations of Use: Use of Tofacitinib in combination with biologic
DMARDs or with potent immunosuppressants such as Azathioprineand Cyclosporine is not recommended.
DOSAGE AND ADMINISTRATION
Tofacitinib may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumaticdrugs (DMARDs). The recommended dose of Tofacitinib is 5 mg twice daily and the recommended dose of Tofacitinib with extended Release (XR) Formulation is 11 mg once daily.
Switching from Tofacitinib 5 mg Tablet to Tofacitinib XR 11mg Tablets
Patients treated with Tofacitinib 5 mg twice daily may be switched to Tofacitinib 11 mg once daily the day following the last dose of Tofacitinib 5 mg
Dosage Modifications due to Serious Infections and Cytopenias
- It is recommended that Tofacitinib not be initiated in patients withan absolute lymphocyte count less than 500 cells/mm3, anabsolute neutrophil count (ANC) less than 1000 cells/mm3 or whohave hemoglobin levels less than 9 g/dL.
- Dose interruption is recommended for management oflymphopenia, neutropenia and anemia
- Avoid use of Tofacitinib if a patient develops a serious infectionuntil the infection is controlled.
Dosage Modifications due to Drug InteractionsIn patients receiving:
- Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g.,Ketoconazole), or
- One or more concomitant medications that result in both moderateinhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g.,Fluconazole), the recommended dose is Tofacitinib 5 mg oncedaily.
- Coadministration of potent inducers of CYP3A4 (e.g., Rifampin)with Tofacitinib may result in loss of or reduced clinical responseto Tofacitinib.
- Coadministration of potent inducers of CYP3A4 with Tofacitinib isnot recommended.
Dosage Modifications in Patients with Renal or HepaticImpairmentIn patients with:
- Moderate or severe renal insufficiency, or
- Moderate hepatic impairment, the recommended dose isTofacitinib 5 mg once daily.
- Use of Tofacitinib in patients with severe hepatic impairment is notrecommended.
