Zelboraf Tablets — Vemurafenib 240 mg (56 Tablets) Roche

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.