Description

1. Product Overview:
Tofaxen® is a tablet formulation of Tofacitinib, a Janus kinase (JAK) inhibitor used in the treatment of autoimmune and inflammatory diseases such as rheumatoid arthritis.

2. Composition:
Active Ingredient: Tofacitinib | Dosage Form: Tablet

3. Pharmacological Class:
Janus Kinase (JAK) Inhibitor / Targeted DMARD

4. Mechanism of Action:
Tofacitinib selectively inhibits JAK enzymes, blocking intracellular signaling pathways involved in inflammation and immune response, thereby reducing cytokine activity and joint damage.

5. Indications:
Rheumatoid arthritis | Psoriatic arthritis | Ulcerative colitis | Other autoimmune inflammatory disorders

6. Dosage & Administration:
As prescribed by physician | Oral use | Usually taken once or twice daily depending on condition | Can be taken with or without food

7. Clinical Benefits:
Reduces joint pain and swelling | Slows disease progression | Improves physical function | Provides targeted immune control

8. Contraindications:
Hypersensitivity to Tofacitinib | Active severe infections | Severe hepatic impairment

9. Precautions:
Increased risk of infections | Monitor blood counts and liver function regularly | Risk of thrombosis in some patients | Use under specialist supervision

10. Drug Interactions:
May interact with strong immunosuppressants, CYP3A4 inhibitors, and inducers, altering drug levels

11. Special Populations:
Pregnancy: Not recommended unless necessary | Lactation: Not recommended | Pediatric: Safety not fully established | Elderly: Increased risk of infections

12. Adverse Effects:
Upper respiratory infections | Headache | Diarrhea | Increased cholesterol levels | Nausea | Risk of serious infections

13. Storage Conditions:
Store below 30°C | Protect from light and moisture | Keep out of reach of children

14. Packaging:
Tablet in blister pack

15. Manufacturer:
Everest Pharmaceutical Ltd.