Description
Generic
Tofacitinib
Indications
Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It can be used as monotherapy or in combination with methotrexate or other nonbiologic Disease Modifying Antirheumatic Drugs (DMARDs).
Dosage and Administration
The recommended dose is 11 mg once daily.Or, as directed by the registered physician.
Interaction
Tofacitinib exposure is increased when Tofacitinib is co-administered with potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and CYP2C19 (e.g., fluconazole). Use of tofacitinib in combination with biologic DMARDs or potent immune suppressants such as azathioprine and cyclosporine is not recommended.
Contraindications
It is contraindicated in patients with hypersensitivity to Tofacitinib or any other components of this product.
Side Effects
The most common side effects arediarrhoea, nasopharyngitis, upper respiratory tract infection, headache and hypertension.
Pregnancy and lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this medicine is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.
Precautions & Warnings
Use of Tofacitinib should be avoided in patients with an active infection, including localized infections. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before administering Tofacitinib.
Storage Conditions
Store below 25o C in a dry place.
