Tofajak 5/10 5 mg / 10 mg FC tablet
PDF Leaflet Revision Date: July 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Moderate to severe active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
Dosage (summary)
RA/PsA: 5 mg twice daily; UC: 10 mg twice daily for 8 weeks, then 5 mg twice daily for maintenance.
Special Populations
- Elderly
- Hepatic impairment
- Renal impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding.
Key Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole)
- CYP inducers (e.g., rifampicin)
Contraindications
- Hypersensitivity to tofacitinib
- Untreated tuberculosis
- Severe hepatic impairment
- Active infections
Common side effects
- Headache
- Hypertension
- Nausea
- Diarrhoea
- Infections
Counselling Points
- Monitor for signs of infection.
- Use effective contraception during treatment.
- Avoid live vaccines during treatment.
Serious warnings
- Serious infections risk
- Malignancy risk
- Gastrointestinal perforation risk
Important Disclaimer
The Tofajak 5/10 5 mg / 10 mg FC tablet professional information leaflet below is the property of Cipla Medpro and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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