Zelboraf Tablets — Vemurafenib 240 mg (56 Tablets) Roche
Zelboraf 240 mg (Vemurafenib) is a high-potency targeted anti-cancer medication, a serine-threonine kinase inhibitor encoded by the BRAF gene. The drug is specifically designed to block the mutated BRAF V600 protein, which triggers uncontrolled cancer cell proliferation. Zelboraf halts tumor growth and induces regression of metastatic lesions in patients with confirmed BRAF V600 mutation status.
Manufacturer: Roche. This version of the product carries Turkish registration (labeled for the Turkish pharmacy market), ensuring its authentic origin and strict compliance with the manufacturing and storage standards set by Roche for international distribution.
Key Features:
- ✅ Targeted Mechanism: Acts exclusively on tumor cells carrying the specific BRAF V600 genetic mutation.
- ✅ Original Medication: Zelboraf is the reference (innovator) drug for the treatment of metastatic melanoma.
- ✅ Clinical Evidence: Proven to significantly improve overall survival and progression-free survival rates.
Zelboraf is indicated for the treatment of:
- 🔹 Adult patients with unresectable or metastatic melanoma positive for the BRAF V600 mutation.
- 🔹 Patients with Erdheim-Chester Disease (ECD) carrying the BRAF V600 mutation.
Note: A validated test for BRAF V600 mutation is required before starting therapy.
Sales Unit: 1 pack containing 56 film-coated tablets, each containing 240 mg of Vemurafenib.
⚠️ APPLICATION INSTRUCTIONS:
- Dosage: The recommended dose is 960 mg (four 240 mg tablets) taken twice daily (total daily dose of 1920 mg).
- Method: Swallow tablets whole with water. May be taken with or without food, but consistency in timing is recommended.
- Interval: Maintain a 12-hour interval between the morning and evening doses.
- Storage: Store in the original package to protect from moisture at temperatures below 30°C.
- ⛔ Wild-type BRAF: Not indicated for use in patients with non-mutated (wild-type) BRAF melanoma.
- ⛔ Pregnancy and Breastfeeding: Vemurafenib may cause fetal harm. Use during pregnancy and nursing is contraindicated.
- Hypersensitivity to Vemurafenib or any of its excipients.
- Pediatric patients (safety and efficacy in children under 18 have not been established).
Treatment requires supervision by a specialized oncologist. Potential side effects include:
- ☀️ Photosensitivity: Increased sensitivity to UV light (sunscreen and protective clothing are mandatory).
- 🧴 Dermatologic: Rash, pruritus, dry skin, and hand-foot syndrome.
- 🦴 Musculoskeletal: Joint pain (arthralgia) and muscle pain.
- 🩺 Secondary Malignancies: Risk of developing cutaneous squamous cell carcinoma (usually manageable by excision).
- 🏃♂️ General: Fatigue, nausea, and decreased appetite.
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