Nublexa Tablet (regorafenib 40mg): Comprehensive Guide
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026
When to Call Your Doctor IMMEDIATELY
- Yellowing of the skin or eyes, dark urine, or severe abdominal pain (possible liver injury).
- Blood in stool or vomit, or coughing up blood (possible bleeding).
- Severe chest pain, shortness of breath, or pain radiating to the arm or jaw (possible heart attack).
- Sudden severe headache, confusion, seizures, or vision changes (possible RPLS).
- Severe abdominal pain with fever and changes in bowel habits (possible gastrointestinal perforation).
- Swelling of the face, lips, tongue, or throat, or difficulty breathing (possible allergic reaction).
- Unusual fatigue, dizziness, or fainting (possible severe anemia or bleeding).
If experiencing severe symptoms, call emergency services immediately.
What is nublexa tablet used for?
This medicine is a prescription oral multikinase inhibitor used to treat metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma. It works by blocking enzymes that promote tumor growth and blood vessel formation. The usual dose is 160 mg once daily for 21 days followed by 7 days off, taken with a low-fat meal. It can cause serious side effects, including liver injury, bleeding, and high blood pressure, so regular monitoring is essential.
- Generic Name: Regorafenib (40mg)
- Manufacturer: Bayer Zydus Pharma Pvt Ltd
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 nublexa tablet के बारे में (Hindi Summary)
उपयोग: यह दवा एक प्रिस्क्रिप्शन-आधारित कैंसर रोधी दवा है जिसमें रेगोराफेनिब सक्रिय घटक है। यह मेटास्टेटिक कोलोरेक्टल कैंसर, गैस्ट्रोइंटेस्टाइनल स्ट्रोमल ट्यूमर और हेपेटोसेलुलर कार्सिनोमा के इलाज के लिए उपयोग की जाती है। यह ट्यूमर की वृद्धि और रक्त वाहिकाओं के निर्माण को रोककर काम करती है। इसका उपयोग केवल कैंसर रोग विशेषज्ञ की देखरेख में ही किया जाना चाहिए।
साइड इफेक्ट्स: इस दवा के सामान्य दुष्प्रभावों में थकान, हाथ-पैर की त्वचा पर लालिमा या छाले, दस्त, भूख में कमी, उच्च रक्तचाप और मुँह के छाले शामिल हैं। गंभीर दुष्प्रभावों में यकृत की क्षति, रक्तस्राव, आंतों में छेद, दिल का दौरा और मस्तिष्क की एक दुर्लभ स्थिति शामिल हो सकती है। नियमित जांच और डॉक्टर से परामर्श आवश्यक है।
सुरक्षा सलाह: यह दवा केवल योग्य कैंसर रोग विशेषज्ञ की देखरेख में ही लें। रोज एक ही समय पर कम वसा वाले भोजन के साथ लें। गोली को पूरा निगलें, चबाएं नहीं। अंगूर और अंगूर के रस से बचें। अन्य दवाओं, सप्लीमेंट्स और जड़ी-बूटियों के बारे में डॉक्टर को बताएं। उपचार के दौरान और बाद में गर्भनिरोधक का उपयोग करें। स्तनपान न कराएं। रक्तचाप की नियमित निगरानी करें और असामान्य लक्षण तुरंत बताएं।
💊 nublexa tablet Uses & Benefits
[{"condition":"Metastatic colorectal cancer","description":"Used in patients who have been previously treated with other therapies such as fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.","evidence":"Well-established"},{"condition":"Gastrointestinal stromal tumors (GIST)","description":"Indicated for patients with locally advanced, unresectable, or metastatic GIST who have failed prior treatment with imatinib and sunitinib.","evidence":"Well-established"},{"condition":"Hepatocellular carcinoma (HCC)","description":"Used as a second-line treatment for patients with hepatocellular carcinoma who have previously been treated with sorafenib.","evidence":"Well-established"}]
Off-label uses: [{"condition":"Refractory osteosarcoma","description":"Sometimes used off-label in patients with relapsed or refractory osteosarcoma based on small studies.","evidence":"Limited"},{"condition":"Advanced soft tissue sarcoma","description":"Occasionally used off-label in certain subtypes of soft tissue sarcoma after failure of standard therapies.","evidence":"Limited"}]
Primary treatment for: Metastatic colorectal cancer
Also treats: Gastrointestinal stromal tumors, Hepatocellular carcinoma
📋 Drug Information
| Generic Name(s) | Regorafenib (40mg) |
| Brand Name | nublexa tablet |
| Manufacturer | Bayer Zydus Pharma Pvt Ltd |
| Packaging / Form | Varies by brand (Allopathy) |
| Therapeutic Class | ANTI NEOPLASTICS |
| Action Class | Tyrosine kinase inhibitors |
| Route of Administration | Oral |
| Storage | Store at room temperature between 20°C and 25°C (68°F to 77°F). Keep the tablets in their original blister pack or bottle, tightly closed, away from moisture and heat. Do not remove the desiccant. Keep out of reach of children. |
| Shelf Life | 24 months from the date of manufacture. |
| WHO Guideline | Not established from the available information. |
| ICMR Guideline | Not established from the available information. |
👨⚕️ Doctor's Practical Tips
Evidence-based practical advice from experienced clinicians
🔍 Is This Medicine Right for Your Symptom?
Educational reference. Always consult a doctor for diagnosis.
🔬 How This Medicine Works (Pharmacology)
Pharmacokinetics
How It Works
This medicine is a multikinase inhibitor that targets multiple protein kinases involved in tumor growth, angiogenesis, and the tumor microenvironment. It inhibits kinases such as VEGFR1, VEGFR2, VEGFR3, TIE2, PDGFR, FGFR, KIT, RET, RAF-1, BRAF, and BRAF V600E. By blocking these kinases, it interferes with signaling pathways that promote cancer cell proliferation, survival, and the formation of new blood vessels that supply the tumor. This dual action helps to slow tumor growth and progression.
Mechanism Steps
💡 How to Take nublexa tablet
Strength: 40 mg immediate-release tablet.
Dosage Information
| Adult Dosage | The recommended dose of this medicine is 160 mg (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle, followed by 7 days off treatment. This dose must be individualized by a qualified clinician based on indication, patient's condition, and tolerability. Dose reductions may be necessary for adverse reactions. The maximum recommended dose is 160 mg per day. Always follow your oncologist's instructions. |
| Pediatric Dosage | Pediatric dosing is not established from available information. Consult a pediatric oncologist. |
| Elderly Dosage | No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be more sensitive to the effects of this medicine and should be monitored closely for adverse reactions. Dose selection should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy. |
| Renal Impairment | No dose adjustment is recommended for patients with mild to moderate renal impairment. This medicine has not been studied in patients with severe renal impairment or end-stage renal disease. Use with caution in these patients and monitor closely for toxicity. |
| Hepatic Impairment | No dose adjustment is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A or B). This medicine is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Monitor liver function closely in all patients. |
| Maximum Daily Dose | 160 mg per day. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of nublexa tablet
✅ Common Side Effects
🚨 Serious Side Effects
⚠️ Rare Side Effects
Consult your doctor if you experience any unusual symptoms.
🔬 Drug Interactions
| Drug | Severity | Effect |
|---|---|---|
| Ketoconazole | Major | |
| Rifampin | Major | |
| Warfarin | Major | |
| Irinotecan | Major | |
| Diclofenac | Moderate | |
| Rosuvastatin | Moderate | |
| Amlodipine | Moderate | |
| Grapefruit juice | Minor | |
| St. John's wort | Minor | |
| Phenytoin | Major |
🚨 Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)
- Warfarin and other anticoagulants
- Anticancer agents (e.g., irinotecan, oxaliplatin)
⚡ Moderate Interactions
- UGT1A9 inhibitors (e.g., diclofenac, phenylbutazone)
- BCRP substrates (e.g., rosuvastatin, methotrexate)
- Antihypertensive agents
🍷 Alcohol Interaction
Alcohol may increase the risk of liver toxicity and gastrointestinal bleeding. It is advisable to avoid alcohol while taking this medicine. Consult your doctor for personalized advice.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Severe hepatic impairment (Child-Pugh C).","Known severe hypersensitivity to regorafenib or any component of the formulation.","Uncontrolled hypertension.","Recent or active severe bleeding.","Pregnancy and breastfeeding."]
⚠️ Warnings & Precautions
["This medicine can cause severe liver injury; monitor liver function closely.","May cause hypertension; monitor blood pressure and treat as needed.","Risk of bleeding; avoid concomitant anticoagulants if possible.","Can cause hand-foot skin reaction; manage with supportive care and dose modification.","May cause gastrointestinal perforation; seek immediate care for severe abdominal pain.","Can cause cardiac ischemia; monitor for chest pain.","May cause reversible posterior leukoencephalopathy syndrome (RPLS); report neurological symptoms.","Avoid use in patients with severe renal impairment; adjust dose if needed.","Use effective contraception during treatment and for 2 months after.","Do not breastfeed during treatment and for 2 weeks after."]
🤱 Lactation Safety
It is not known whether this medicine is present in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment with this medicine and for at least 2 weeks after the last dose.
💊 Overdose Management
There is no specific antidote for overdose with this medicine. In case of suspected overdose, discontinue the medicine and provide supportive care. Monitor vital signs and liver function. Gastric lavage may be considered if ingestion is recent. Contact a poison control center for guidance.
⏰ Missed Dose
If you miss a dose of this medicine, take it as soon as you remember on the same day. If it is almost time for your next dose (within 12 hours), skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed dose. If you vomit after taking a dose, do not take another dose that day; resume your normal schedule the next day.
Additional Safety Advice
This medicine must only be taken under the supervision of a qualified oncologist. Do not start, stop, or change the dose without consulting your doctor. Take the tablet at the same time each day, with a low-fat meal (containing less than 30% fat) to improve absorption and reduce stomach upset. Swallow the tablet whole with water; do not crush or chew it. Avoid grapefruit and grapefruit juice, as they can increase the levels of this medicine in your body. Inform your doctor about all other medicines, supplements, and herbal products you are taking, especially blood thinners, antibiotics, and antifungals. Use effective contraception during treatment and for at least 2 months after the last dose if you are of childbearing potential. Do not breastfeed while taking this medicine. Avoid activities that increase the risk of bleeding or injury. Monitor your blood pressure regularly and report any severe headache, vision changes, or chest pain immediately. Keep all appointments for blood tests and imaging. Store this medicine at room temperature away from moisture and heat.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients (above 65 years) may be more sensitive to the effects of this medicine, particularly fatigue, hypertension, and liver toxicity. No specific dose adjustment is recommended based on age alone, but close monitoring is advised. Dose selection should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and concomitant disease or other drug therapy.
🤰 Pregnancy Planning (TTC)
This medicine can cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 2 months after the last dose. Men with female partners of childbearing potential should also use effective contraception during treatment and for at least 2 months after the last dose. If you are planning to become pregnant, consult your doctor before starting or stopping this medicine.
🏥 Post-Surgery Considerations
This medicine can increase the risk of bleeding and impair wound healing. It should be stopped before any planned surgery, and your surgeon and oncologist should be informed. Typically, treatment should be interrupted at least 2 weeks before surgery and resumed only after adequate wound healing, as advised by your doctor. Monitor for signs of bleeding or infection after surgery.
🦷 Dental Procedures
This medicine can increase the risk of bleeding and infection. Inform your dentist that you are taking this medicine before any dental procedure. Your dentist may recommend postponing elective dental work until your blood counts and bleeding risk are assessed. For urgent dental procedures, your doctor may advise temporary interruption of this medicine. Maintain good oral hygiene to prevent dental problems.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
This medicine can cause fatigue, high blood pressure, and bleeding. Avoid strenuous exercise or activities that increase the risk of injury or bleeding. Light to moderate exercise, such as walking or swimming, may be beneficial, but consult your doctor before starting any exercise program. If you experience chest pain, shortness of breath, or dizziness during exercise, stop immediately and seek medical attention.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause fatigue, dizziness, and high blood pressure, which can affect your ability to drive or operate machinery. Avoid driving or operating heavy machinery until you know how this medicine affects you. You may need to adjust your work schedule to accommodate treatment cycles and medical appointments. Discuss any work-related concerns with your doctor and employer. Most patients can continue with light daily activities, but strenuous work may need to be modified.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your doctor. Treatment may be stopped if you experience severe or life-threatening side effects, if the cancer progresses, or if you decide with your doctor that the risks outweigh the benefits. Your doctor may also interrupt treatment temporarily for dose reduction or management of side effects. Always follow your oncologist's guidance regarding when to stop.
📅 Long-Term Use Effects
Long-term use of this medicine may lead to cumulative toxicities, including liver injury, hypertension, hand-foot skin reaction, and fatigue. Regular monitoring of liver function, blood pressure, and blood counts is essential. Some patients may experience thyroid dysfunction or cardiac issues. The benefits of continued treatment should be weighed against the risks, and dose adjustments or treatment breaks may be necessary. Long-term survival benefits have been observed in clinical trials for approved indications.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
Enrollment in clinical trials of new therapies may be an option for patients who cannot tolerate or do not respond to this medicine.
Evidence: VariesPalliative care can help manage symptoms and improve quality of life alongside cancer treatment.
Evidence: Well-establishedDepending on the cancer type and mutations, other targeted therapies or immunotherapies may be appropriate.
Evidence: Well-established for specific indications💉 Vaccination Considerations
💉 If You're Getting Vaccinated
Live vaccines should be avoided during treatment with this medicine because of the potential for increased risk of infection. Inactivated vaccines may be administered, but their effectiveness may be reduced due to immunosuppression. Consult your doctor before receiving any vaccination.
📦 Storage Guide
✅ DO
Store at room temperature between 20°C and 25°C (68°F to 77°F).
❌ DON'T
Do not refrigerate or freeze.
✅ DO
Keep the tablets in their original blister pack or bottle, tightly closed.
❌ DON'T
Do not transfer to unmarked containers.
✅ DO
Keep away from moisture, heat, and direct sunlight.
❌ DON'T
Do not store in the bathroom cabinet.
✅ DO
Keep out of reach of children and pets.
❌ DON'T
Do not use after the expiry date.
✈️ Traveling with This Medicine
When traveling, carry this medicine in its original packaging with the prescription label. Bring a copy of your prescription and a letter from your doctor explaining that you are carrying this medicine for cancer treatment. Keep the medicine in your carry-on luggage to avoid loss or temperature extremes. Store at room temperature and avoid direct sunlight. If crossing time zones, maintain your dosing schedule as close to every 24 hours as possible; consult your doctor for specific advice. Check customs regulations for controlled substances in your destination country.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: This medicine may take several weeks to show clinical benefit. Tumor response is typically assessed after 6-8 weeks of treatment. It is important to continue taking it as prescribed and attend all follow-up appointments.
A: Yes, take this medicine with a low-fat meal (less than 30% fat). Avoid high-fat meals and grapefruit juice, as they can increase drug levels and side effects.
A: The most common side effects include hand-foot skin reaction, diarrhea, fatigue, decreased appetite, high blood pressure, and mouth sores. Most can be managed with supportive care and dose adjustments.
A: No, do not stop taking this medicine without consulting your doctor. Stopping suddenly may cause the cancer to progress. Your doctor will decide when and how to stop treatment.
A: This medicine can cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 2 months after the last dose. Do not breastfeed during treatment and for 2 weeks after.
🤔 Common Patient Concerns
🔄 Substitutes for nublexa tablet
View AllAlternative brands with exact same active ingredient:
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: This medicine can cure cancer.
Fact: This medicine is not a cure for cancer. It can slow disease progression and extend survival but does not eliminate cancer completely. - Myth: You can stop taking this medicine once you feel better.
Fact: You should not stop taking this medicine without consulting your doctor. Stopping suddenly may cause the cancer to progress. - Myth: This medicine has no serious side effects.
Fact: This medicine can cause serious side effects, including liver injury, bleeding, and heart problems. Regular monitoring is required. - Myth: You can take this medicine with any food.
Fact: This medicine should be taken with a low-fat meal. High-fat meals can increase drug levels and toxicity.