Tofator 5mg Tablet

Rheumatoid Arthritis: Tofator 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 nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Psoriatic Arthritis: Tofator 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).

Ulcerative Colitis: Tofator is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

Pharmacology

Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. (3) Cytokines signalling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the janus kinase signalling pathway.

Interaction

• Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole)
• Recommended dose is Tofator 5 mg once daily: One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole)
• Recommended dose is Tofator 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.

Side Effects

The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with Tofator monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.

Pregnancy & 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.

Precautions & Warnings

• Serious Infections: Avoid use of Tofator during an active serious infection, including localized infections.
•  Gastrointestinal Perforations: Use with caution in patients that may be at increased risk.
• Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids.
• Immunizations: Live vaccines: Avoid use with Tofator.Do not initiate Tofator if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 gm/dL.

Therapeutic Class

Immunosuppressant

Storage Conditions

Store below 30°C. Protect from light & moisture. Keep all medicines out of the reach of children.