Regonat (Regorafenib) 40 mg Tablets (Pack of 28/84)

Indicated for the treatment of patients with:

• Metastatic Colorectal Cancer (CRC): Who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
• Gastrointestinal Stromal Tumors (GIST): Unresectable or metastatic, after failure of Imatinib and Sunitinib.
• Hepatocellular Carcinoma (HCC): For patients previously treated with Sorafenib.

Strength: 40 mg per tablet.

Standard Dosage: 160 mg (4 tablets) taken once daily.

Treatment Cycle:

• 📅 3 weeks ON (21 days).
• 📅 1 week OFF (7 days).

⚠️ IMPORTANT FOOD INSTRUCTION:

Take Regonat after a low-fat meal (less than 30% fat).
Examples: Cereal, toast, or low-fat yogurt. Avoid high-fat meals as they increase toxicity, but do not take on an empty stomach.

Storage Warning: Highly moisture sensitive. Keep tablets in the bottle with the desiccant. Once opened, use within 7 weeks.

• Severe hepatic impairment (Liver failure).
• Active bleeding or recent hemorrhage.
• Pregnancy and breastfeeding.
• Recent or planned major surgery (impairs wound healing).

Common adverse reactions include:

• Hand-Foot Skin Reaction (HFSR): Redness, pain, and peeling of palms and soles.
• Dysphonia: Hoarseness or voice changes.
• Fatigue and Hypertension.
• Diarrhea and hepatotoxicity (liver enzyme monitoring is required).