Stivarga Tablets — Regorafenib 40 mg (28 Tablets) Bayer
Stivarga 40 mg (Regorafenib) is a broad-spectrum multikinase inhibitor and targeted anticancer agent. Regorafenib simultaneously blocks a wide range of protein kinases involved in tumor growth, angiogenesis, and the maintenance of the tumor microenvironment, including RET, VEGFR1–3, KIT, PDGFR-α/β, FGFR, RAF, and MEK. This multi-targeted approach allows for the concurrent suppression of tumor proliferation, vascularization, and metastatic spread.
Manufacturer: Bayer HealthCare Pharmaceuticals. Stivarga is the original innovator drug, developed by Bayer and validated through landmark clinical trials (CORRECT, GRID, RESORCE) that demonstrated its clinical benefit across multiple tumor types. Manufactured to the highest global quality standards.
Key Features:
- ✅ Broad-Spectrum Kinase Inhibition: Targets more than 10 oncogenic kinases simultaneously, including VEGFR, PDGFR, and FGFR receptors.
- ✅ Anti-Angiogenic Activity: Disrupts tumor blood vessel formation, cutting off the nutrient supply that sustains tumor growth.
- ✅ Therapy for Refractory Cancers: Designed for patients whose tumors have progressed on or are resistant to standard treatment regimens.
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.
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