Tofacit XR 11 mg (Tablet (Extended Release))

Indications

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ulcerative Colitis

Pharmacology

Tofacitinib is a partial and reversible janus kinase (JAK) inhibitor that prevents the body from responding to cytokine signals by inhibiting JAKs to decrease the inflammatory response.

Dosage & Administration

• Rheumatoid Arthritis: Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily
• Psoriatic Arthritis: Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily
• Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily if adequate therapeutic benefit is not achieved

Interaction

• Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole)
• Recommended dose is Tofacit XR 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 Tofacit XR 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response

Side Effects

Commonly reported adverse reactions during the first 3 months were upper respiratory tract infections, headache, diarrhea, and nasopharyngitis.

Pregnancy & Lactation

Pregnancy Category C. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

• Avoid use during an active serious infection, including localized infections
• Use with caution in patients at increased risk of gastrointestinal perforations
• Laboratory monitoring recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids
• Avoid use with live vaccines
• Do not initiate if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3, or hemoglobin <9 gm/dL

Use in Special Populations

• Pediatric Use: Safety and effectiveness not established
• Geriatric Use: Higher incidence of infections in the elderly population
• Moderate and severe renal impairment or moderate hepatic impairment: Half the total daily dosage recommended for patients with normal renal and hepatic function

Therapeutic Class

Immunosuppressant

Storage Conditions

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

Related Brands

• Tofacit 5 mg (Tablet) - delta-pharma-ltd
• Jaktor 5 mg (Tablet) - beacon-pharmaceuticals-plc