Tofawin 5

Composition:

  • Tofacitinib 5 mg
    Therapeutic Class:

  • Janus Kinase (JAK) Inhibitor / Targeted Synthetic DMARD
    Schedule: Schedule H (Prescription Only)

Tofawin 5 contains Tofacitinib, an orally administered JAK inhibitor that modulates immune signaling pathways involved in chronic inflammatory diseases. It is approved for treating moderate to severe rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, especially in patients who have had an inadequate response to conventional DMARDs or biologics.

Usage of Tofawin 5

Tofawin 5 is indicated for:

  • Rheumatoid Arthritis (RA) – moderate to severe, as monotherapy or in combination with methotrexate or other DMARDs

  • Psoriatic Arthritis (PsA) – in patients with inadequate response to NSAIDs or DMARDs

  • Ulcerative Colitis (UC) – moderate to severe cases not responding to standard therapies

  • Off-label: Ankylosing spondylitis, alopecia areata (emerging use), and COVID-19-related hyperinflammation (under clinical study)


Mechanism of Action

Tofacitinib inhibits Janus kinase (JAK) enzymes, primarily JAK1 and JAK3, interfering with the JAK-STAT signaling pathway, which transmits signals from cytokine receptors to the cell nucleus.

This leads to:

  • Suppression of pro-inflammatory cytokines (IL-6, IFN-γ, IL-2, etc.)

  • Reduction in immune cell activation

  • Modulation of autoimmune and inflammatory responses


Key Benefits

Rapid onset of action in reducing joint pain and swelling (RA & PsA)
✅ Oral administration – non-injectable alternative to biologics
✅ Effective in patients unresponsive to methotrexate or TNF inhibitors
Steroid-sparing in ulcerative colitis
✅ Improves quality of life and physical functioning


Common Side Effects

  • Upper respiratory tract infections

  • Headache

  • Diarrhea or GI upset

  • Hypertension

  • Increased liver enzymes

Serious risks include infections, herpes zoster, thromboembolism, and malignancy in long-term use. Careful monitoring is essential.


Precautions

  • Screen for tuberculosis, hepatitis B/C, and latent infections before starting

  • Avoid use in patients with active infections

  • Monitor CBC, lymphocytes, neutrophils, and lipid profile regularly

  • Use with caution in elderly, smokers, and patients with CV risk factors

  • Pregnancy: Not recommended (Category C); use contraception during and 4–6 weeks after therapy

  • Not recommended with biologic DMARDs or potent immunosuppressants (e.g., azathioprine, cyclosporine)


Drug Interactions

  • Metabolized by CYP3A4 and CYP2C19

  • Avoid strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)

  • Monitor dose when used with fluconazole or rifampicin

  • Avoid live vaccines during and shortly after treatment


Dosage and Administration

  • Rheumatoid Arthritis / Psoriatic Arthritis: 5 mg twice daily

  • Ulcerative Colitis: Induction – 10 mg twice daily for 8 weeks, then maintenance at 5 mg BID

  • Dose adjustment may be needed in renal or hepatic impairment

  • Can be taken with or without food


Storage

  • Store at room temperature (<25°C)

  • Keep in a dry place, away from direct sunlight

  • Keep out of reach of children


Patient Counseling Points

  • Inform doctor of any signs of infection, fever, or fatigue

  • Complete blood and liver tests as scheduled

  • Do not stop medication without physician’s advice

  • Avoid pregnancy during and for several weeks after treatment

  • Maintain regular monitoring to ensure safe use

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