Stivarga Tablets — Regorafenib 40 mg (28 Tablets) Bayer

Stivarga is indicated for the treatment of adult patients with:

• 🔹 Metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
• 🔹 Locally advanced, unresectable, or metastatic gastrointestinal stromal tumor (GIST) previously treated with imatinib mesylate and sunitinib malate.
• 🔹 Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.

Sales Unit: 1 bottle containing 28 film-coated tablets of 40 mg Regorafenib.

⚠️ APPLICATION INSTRUCTIONS:

• Dosage: The recommended dose is 160 mg (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day treatment cycle. Treatment continues until disease progression or unacceptable toxicity.
• Method: Swallow tablets whole with a low-fat breakfast (less than 30% fat content) at the same time each day.
• Caution: Do not crush or break the tablets. Regular monitoring of liver function and blood pressure is required throughout treatment.
• Storage: Store at or below 30°C. Keep the bottle tightly closed after each use.

• ⛔ Pregnancy and Breastfeeding: Demonstrated embryolethal and teratogenic effects in animal studies. Strictly contraindicated during pregnancy and nursing. Effective contraception required during treatment and for 2 months after the last dose (for both female and male patients).
• ⛔ Severe Hepatic Impairment: Not recommended in patients with severe hepatic impairment (total bilirubin >3× ULN), as Stivarga has not been studied in this population.
• ⛔ Drug Interactions: Concomitant use with strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John's Wort) or strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole) is contraindicated.
• Hypersensitivity to Regorafenib or any excipients.
• Pediatric use (under 18 years) — safety and efficacy have not been established.

Regular medical supervision, including liver function monitoring and blood pressure checks, is essential. Potential side effects include:

• 🖐️ Hand-Foot Skin Reaction (HFSR): The most characteristic adverse effect — redness, pain, and peeling of the skin on palms and soles, occurring in over 50% of patients.
• 🩺 Hepatotoxicity: Elevated ALT, AST, and bilirubin levels; rarely, severe hepatic failure. Liver function tests required every 2 weeks during the first 2 months of treatment.
• 🩸 Hypertension: Occurs in 30–59% of patients, typically during the first treatment cycle.
• 🤢 Gastrointestinal: Diarrhea, nausea, decreased appetite, and abdominal pain.
• 😴 General: Fatigue, asthenia, dysphonia (voice changes), and weight loss.
• 🦠 Infections: Increased susceptibility to infections.