Tofatin 5: Each film coated tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 5 mg.

Tofatin-XR: Each extended release tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 11 mg.

Tofacitinib is believed to interfere with the activity of an enzyme called Janus kinase (JAK), which activates other cellular components which normally start the immune response in the body. By reducing the immune response Tofacitinib reduces the signs and symptoms of rheumatoid arthritis. 

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 may be used as monotherapy or in combination with Methotrexate or other non-biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). 

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 may be used as monotherapy or in combination with Methotrexate or other non-biologic Disease-Modifying Antirheumatic Drugs (DMARDs). Tofacitinib is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). 

Tofacitinib is a medicine that affects immune system and can lower the ability of immune system to fight infections such as tuberculosis, and infections caused by bacteria, fungi or viruses that can spread throughout the body. These infections may lead to hospitalization or death. Most patients who developed these infections were taking other immunosuppressants at the same time such as Methotrexate or corticosteroids. Tofacitinib should not be used in any type of infection.

Hepatic Impairment Use of Tofacitinib in patients with severe hepatic impairment is not recommended. No dose adjustment is required in patients with mild hepatic impairment.

Renal Impairment Use of Tofacitinib in patients with severe renal impairment is not recommended. No dose adjustment is required in patients with mild renal impairment.

None

Pregnancy Category C. 

Tofatin 5 : Each carton contains 1x10’s tablets in blister strips. Tofatin-XR : Each carton contains 1x10’s tablets in blister strips.

The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were upper respiratory tract infections, headache, diarrhea and nasopharyngitis. 

Tofacitinib may increase risk of adverse reactions and decrease antibody response to live vaccines; avoid concurrent use. Blood levels and effects may be increased by strong CYP3A4 inhibitors including ketoconazole or moderate CYP3A4 inhibitors/strong CYP2C19 inhibitors including Fluconazole; dose decrease is recommended. Blood levels and effectiveness may be decreased by strong CYP3A4 inducers including Rifampin; avoid concurrent use. Increase risk of immune suppression when used concurrently with other potent immunosuppressant’s including Azathioprine, Cyclosporine, Tacrolimus, Antineoplastics or radiation therapy.

The safety and effectiveness of Tofacitinib in pediatric patients have not been established

As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly

Keep in a cool & dry place, away from light. Keep out of reach of children.