Zelborafa 240 mg FC tablets
PDF Leaflet Revision Date: 14 April 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Monotherapy for BRAF V600E mutation-positive unresectable or metastatic melanoma.
Dosage (summary)
960 mg (4 tablets) twice daily, taken consistently with respect to meals.
Special Populations
- Elderly population
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Not recommended in pregnancy; breastfeeding should be discontinued during treatment.
Key Drug Interactions
- CYP1A2 inhibitors/inducers
- CYP3A4 inhibitors/inducers
- Warfarin
Contraindications
- Hypersensitivity to vemurafenib
- Severe hepatic impairment
- Pregnancy
Common side effects
- Arthralgia
- Fatigue
- Rash
- Photosensitivity
- Nausea
Counselling Points
- Confirm BRAF V600E mutation status before treatment.
- Avoid sun exposure; use sunscreen.
- Report any skin changes immediately.
Serious warnings
- QT prolongation
- Severe hypersensitivity reactions
- Dermatological reactions
Important Disclaimer
The Zelborafa 240 mg FC tablets professional information leaflet below is the property of Roche Products 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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