Tofacent XR

Indications

Tofacent is prescribed for the treatment of:

• Rheumatoid Arthritis: For adults with moderately to severely active rheumatoid arthritis who have not responded adequately to or are intolerant of methotrexate. Tofacent can be used alone or alongside methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
• Psoriatic Arthritis: For adults with active psoriatic arthritis who have had an insufficient response or intolerance to methotrexate or other DMARDs.
• Ulcerative Colitis: For adults with moderately to severely active ulcerative colitis.

Pharmacology

Tofacent contains tofacitinib, a selective Janus kinase (JAK) inhibitor that blocks the JAK-STAT signaling pathway, which plays a role in inflammation. By inhibiting JAKs, tofacitinib reduces cytokine signaling and the immune response, thus helping to control inflammation in diseases such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.

Dosage & Administration

• Rheumatoid Arthritis:
  • Initial dose: 5 mg twice daily or 11 mg once daily.
  • For patients with moderate to severe renal or hepatic impairment: 5 mg once daily.
• Psoriatic Arthritis:
  • Initial dose: 5 mg twice daily or 11 mg once daily.
  • For patients with moderate to severe renal or hepatic impairment: 5 mg once daily.
• Ulcerative Colitis:
  • Initial dose: 10 mg twice daily for 8 weeks, then reduce to 5 or 10 mg twice daily. Discontinue if no adequate therapeutic benefit is seen after 16 weeks of 10 mg twice daily.

Interactions

• CYP3A4 Inhibitors (e.g., ketoconazole): Reduce dose to 5 mg once daily.
• CYP3A4 Inducers (e.g., rifampin): May reduce clinical effectiveness.

Side Effects

Common side effects include upper respiratory tract infections, headaches, diarrhea, and nasopharyngitis, particularly during the first three months of treatment.

Pregnancy & Lactation

• Pregnancy: Category C. Tofacent should be used during pregnancy only if the potential benefit outweighs the risks to the fetus.
• Lactation: It is not known whether tofacitinib is excreted in breast milk. Nursing mothers should weigh the risks to the infant and the benefits to the mother when deciding whether to continue breastfeeding or discontinue the drug.

Precautions & Warnings

• Infections: Avoid use in patients with serious active infections.
• Gastrointestinal Perforations: Use with caution in patients at increased risk.
• Laboratory Monitoring: Regular monitoring is recommended for changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.
• Live Vaccines: Avoid use with live vaccines.

Use in Special Populations

• Pediatric Use: The safety and effectiveness of Tofacent in children have not been established.
• Geriatric Use: Elderly patients may experience a higher incidence of serious infections. Use with caution in patients 65 years and older.
• Renal and Hepatic Impairment: Reduce the dosage for patients with moderate to severe renal or hepatic impairment.

Therapeutic Class

Immunosuppressant

Storage Conditions

Store below 30°C. Protect from light and moisture. Keep out of reach of children.