Description
Comprehensive Guide to Regdual 40mg Tablet (Regorafenib)
Regdual 40mg Tablet is an oral targeted anti-cancer medicine manufactured by Intas Pharmaceuticals Ltd. Each film-coated tablet contains 400 mg of Regorafenib (40 mg per tablet), an active pharmaceutical ingredient belonging to the class of multi-kinase inhibitors (tyrosine kinase inhibitors).
Regdual is prescribed under specialist oncologist supervision to treat advanced gastrointestinal and liver cancers in adult patients. Unlike traditional cytotoxic chemotherapy that affects all rapidly multiplying cells, Regdual selectively targets specific proteins and enzymes that cancer cells need to grow, build blood vessels, and spread.
Quick Product Fact Sheet
| Feature | Details |
| Brand Name | Regdual 40mg Tablet |
| Active Ingredient | Regorafenib (40 mg per tablet) |
| Manufacturer | Intas Pharmaceuticals Ltd. |
| Therapeutic Class | Anti-neoplastic agent |
| Pharmacological Class | Multi-kinase / Tyrosine Kinase Inhibitor (TKI) |
| Packaging | Bottle of 28 tablets |
| Standard Adult Dose | 160 mg (four 40mg tablets) once daily for 21 days on, 7 days off |
| Meal Instruction | Take once daily with a low-fat breakfast |
How Regdual 40mg Works
Regorafenib mechanism of action:
Solid tumors cannot expand beyond a small size without developing their own network of blood supply to obtain oxygen and nutrients. Malignant cells signal surrounding tissues through proteins and enzymes called kinases.
Regdual acts as a multi-kinase inhibitor by blocking several key pathways simultaneously:
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Anti-Angiogenesis (Stopping Blood Supply): It blocks VEGFR-1, VEGFR-2, VEGFR-3, and TIE-2 receptors. This stops the tumor from growing new blood vessels (angiogenesis).
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Oncogenesis Inhibition (Halting Tumor Growth): It blocks KIT, RET, RAF-1, and BRAF kinases, shutting down internal cellular signals that tell cancer cells to multiply.
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Tumor Microenvironment Blockade: It targets PDGFR and FGFR receptors, preventing neighboring stromal cells from supporting cancer survival.
By blocking these multiple targets, Regdual starves the tumor, slows cancer spread, and prompts programmed cancer cell death (apoptosis).
Approved Medical Uses
Regdual 40mg Tablet is indicated for adult patients in three main cancer settings:
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Metastatic Colorectal Cancer (mCRC): Used for advanced colon or rectal cancer that has spread to other parts of the body, specifically in patients who have already received other standard chemotherapy regimens (such as fluoropyrimidine-, oxaliplatin-, and irinotecan-based therapies, anti-VEGF therapy, and an anti-EGFR therapy if appropriate).
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Gastrointestinal Stromal Tumors (GIST): Used for locally advanced, unresectable, or metastatic GIST (a type of soft tissue sarcoma in the stomach or bowel) in patients whose disease progressed on or who could not tolerate prior treatments with imatinib and sunitinib.
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Hepatocellular Carcinoma (HCC – Liver Cancer): Prescribed for adult patients with advanced primary liver cancer who have previously been treated with the anti-cancer medication sorafenib.
Standard Dosage and How to Take
Regdual must be taken strictly as prescribed by your oncologist. Never alter your dose or stop taking it without direct medical guidance.
Standard 28-Day Treatment Cycle
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Typical Dose: The standard adult dose is 160 mg once daily (taken as four 40mg tablets together at the same time each day).
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Cycle Schedule: Take the tablets daily for 21 days (3 weeks), followed by 7 days of rest (no medicine). This completes one 28-day treatment cycle.
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Cycle Repeat: Cycles are repeated as directed by your oncologist as long as the treatment remains effective and side effects are manageable.
Days 1 to 21: [Take 4 Tablets (160mg) Once Daily] Days 22 to 28: [7-Day Rest Period - No Tablets]
Important Administration Rules
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Take with a Low-Fat Meal: Take Regdual with a light, low-fat meal (containing less than 30% fat and around 300 to 500 calories, such as cereal with skim milk or toast with a small amount of jam). Taking it with high-fat meals significantly alters how much medicine your body absorbs.
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Swallow Whole: Swallow the tablets whole with a full glass of water. Do not chew, crush, or break the tablets.
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Timing Consistency: Take your dose at the same time every morning.
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Missed Dose: If you miss a dose on a given day, take it as soon as you remember that same day. If the entire day has passed, skip the missed dose and continue your regular schedule the next morning. Never take double tablets to make up for a missed dose.
Potential Side Effects & Management
Like most targeted oncology therapies, Regdual can cause side effects. Routine clinical check-ups help catch and manage these early.
Common Regorafenib side effects
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Hand-Foot Skin Reaction (HFSR): Redness, pain, swelling, blisters, or thick calluses on the palms of the hands and soles of the feet.
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High Blood Pressure (Hypertension): Blood pressure frequently rises, often during the first few weeks of therapy.
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Gastrointestinal Effects: Diarrhea, nausea, vomiting, decreased appetite, and weight loss.
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Voice Changes (Dysphonia): Hoarseness or changes in voice pitch.
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Constitutional Symptoms: Extreme fatigue, weakness, or mild fever.
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Mouth Irritation (Mucositis/Stomatitis): Painful mouth sores or dry mouth.
Serious Warnings (Seek Immediate Emergency Care)
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Severe Liver Toxicity (Hepatotoxicity): Regorafenib can cause severe, potentially fatal liver damage. Watch for yellowing of the skin or eyes (jaundice), dark brown/tea-colored urine, light-colored stools, or pain in the upper right side of your stomach.
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Severe Bleeding (Hemorrhage): Can increase the risk of serious bleeding. Report coughing up blood, dark or tarry stools, unusual bruising, or blood in the urine immediately.
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Gastrointestinal Perforation or Fistula: Severe, sudden stomach pain with fever or chills.
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Heart Problems & Heart Attack: Chest pain, shortness of breath, unexplained dizziness, or irregular heartbeat.
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Reversible Posterior Leukoencephalopathy Syndrome (RPLS): A rare brain condition marked by severe headache, confusion, seizures, or vision loss.
Precautions & Medical Monitoring
| Monitoring Parameter | Recommended Frequency | Purpose |
| Liver Function Tests (ALT, AST, Bilirubin) | Baseline, then every 2 weeks for the first 2 months, then monthly | Tracks liver enzymes to detect drug-induced liver injury early. |
| Blood Pressure Monitoring | Weekly for the first 6 weeks, then at every clinic visit | Detects early spikes in blood pressure; anti-hypertensive medication is often prescribed. |
| Complete Blood Count (CBC) | Baseline and periodic | Monitors for anemia, low platelets (bleeding risk), and low white blood cells (infection risk). |
| Skin / Foot Evaluation | Routine clinic checks | Identifies Hand-Foot Skin Reaction early to allow dose adjustments or topical care. |
Surgical and Healing Warning
Regdual blocks blood vessel formation, which severely impairs normal wound healing. Stop taking Regdual at least 2 weeks before any planned surgery or dental procedure. Do not resume treatment until your surgical incisions are fully healed.
Drug Interactions & Dietary Precautions
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Grapefruit and Grapefruit Juice: Strictly avoid grapefruit and grapefruit juice. They block the CYP3A4 liver enzyme and cause Regdual levels in your blood to rise to dangerous levels.
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Strong CYP3A4 Inducers (e.g., Rifampin, Phenytoin, Carbamazepine, St. John’s Wort): These lower the level of regorafenib in your bloodstream, making the cancer treatment ineffective.
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Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Clarithromycin, Itraconazole): These slow the breakdown of regorafenib, increasing the risk of toxic side effects.
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Blood Thinners (Warfarin, Heparin): Taking Regdual alongside anticoagulants significantly increases bleeding risks and requires frequent monitoring.
Special Population Guidance
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Pregnancy (Strictly Unsafe): Regdual causes severe harm to an unborn baby. Females of childbearing potential must use effective birth control during treatment and for at least 8 weeks after the last dose.
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Male Contraception: Male patients with female partners of childbearing potential must use reliable barrier contraception during therapy and for at least 8 weeks after the final dose.
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Breastfeeding (Contraindicated): Do not breastfeed while taking Regdual and for at least 2 weeks after the last dose, as it can harm the nursing child.
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Children & Adolescents: Regdual is not approved for use in individuals under 18 years of age.
Storage and Handling
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Store tablets at room temperature below 30°C (86°F).
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Keep the tablets in the original bottle tightly sealed with the desiccant pouch inside to protect against moisture.
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Keep strictly out of reach of children and pets.
Regorafenib vs Lonsurf
| Feature / Parameter | Regorafenib (Stivarga / Regdual) | Lonsurf (Trifluridine and Tipiracil) |
| Active Molecule(s) | Regorafenib | Trifluridine (cytotoxic nucleoside) + Tipiracil (thymidine phosphorylase inhibitor) |
| Drug Class | Multi-kinase / Tyrosine Kinase Inhibitor (TKI) | Antimetabolite / Cytotoxic Nucleoside Analogue |
| Primary Mechanism | Targeted anti-angiogenesis (blocks VEGFR 1–3, TIE-2), oncogenesis (KIT, RET, RAF), and tumor microenvironment (PDGFR, FGFR) | Trifluridine incorporates directly into cancer DNA to cause strand breaks; tipiracil blocks its breakdown |
| Approved Indications |
• Metastatic Colorectal Cancer (mCRC) • Advanced Gastrointestinal Stromal Tumors (GIST) • Hepatocellular Carcinoma (HCC – Liver Cancer) |
• Metastatic Colorectal Cancer (mCRC) • Metastatic Gastric / Gastroesophageal Junction (GEJ) Adenocarcinoma |
| Combination Therapy | Primarily used as monotherapy (dose-escalation strategy common) | Monotherapy OR combined with Bevacizumab (SUNLIGHT trial regimen) |
| Standard Dosing | 160 mg once daily (four 40mg tablets taken together) | 35 mg/m² twice daily (calculated by Body Surface Area, max 80 mg/dose) |
| Schedule / Cycle | 21 days on, 7 days off (28-day repeated cycle) | Days 1–5 on, 2 days off; Days 8–12 on, 2 days off; 14 days rest (28-day repeated cycle) |
| Food Instructions | Take once daily in the morning with a low-fat meal (<30% fat, ~300–500 calories) | Take within 1 hour after finishing morning and evening meals |
| Most Common Side Effects |
• Hand-Foot Skin Reaction (HFSR) • Hypertension (high blood pressure) • Fatigue & voice changes (dysphonia) • Diarrhea & weight loss |
• Neutropenia (low white blood cells) • Anemia & thrombocytopenia • Nausea & vomiting • Fatigue & diarrhea |
| Primary Organ Risk / Monitoring | Liver Toxicity & Blood Pressure: Biweekly Liver Function Tests (LFTs) for first 2 months; regular BP checks | Bone Marrow Suppression (Myelosuppression): Complete Blood Count (CBC) prior to cycle start and on Day 15 of every cycle |
| Wound Healing & Surgery | High risk: Halts blood vessel repair; must stop at least 2 weeks before surgery and withhold post-op until healed | Lower vascular risk: Avoid during active surgical recovery due to infection risk from neutropenia |
| Special Handling | Standard handling; keep desiccant in original bottle | Cytotoxic oral chemotherapy; caregivers should wear gloves when handling |
Frequently Asked Questions (FAQs)
Q1: How can I manage the skin peeling and pain on my hands and feet?
Use thick, fragrance-free moisturizing creams on your hands and feet. Avoid tight footwear, avoid hot water on hands and feet, and wear soft cotton socks. If painful blisters or calluses develop, notify your oncologist promptly; they may temporarily pause or lower your dose.
Q2: Can I take all four tablets of Regdual at different times during the day?
No. You should take all four 40mg tablets together as a single 160mg dose once daily, in the morning with a low-fat breakfast, to ensure proper absorption and effectiveness.
Q3: What should I eat for a “low-fat breakfast”?
A low-fat breakfast should contain less than 30% fat. Good examples include a bowl of cereal or oatmeal with skim or low-fat milk, toast with fruit jam, or fruit with black tea or coffee. Avoid fried foods, eggs cooked in butter, bacon, and whole milk.
Medical Disclaimer
This guide is for informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified oncologist or healthcare professional before starting, stopping, or adjusting any anti-cancer medication.
References
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U.S. Food and Drug Administration (FDA):STIVARGA (regorafenib) Tablets Prescribing Information.
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National Center for Biotechnology Information (NCBI):Regorafenib: A Review in Advanced Colorectal Cancer, GIST, and Hepatocellular Carcinoma.
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MedlinePlus (National Library of Medicine):Regorafenib Oral Route Monograph.
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Electronic Medicines Compendium (EMC):Stivarga 40mg Film-Coated Tablets Summary of Product Characteristics (SmPC).
James Davis –
Would definitely purchase it again.