Xovoltib 30mg Tablet (Afatinib): Comprehensive Medicine Guide
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026
When to Call Your Doctor IMMEDIATELY
- Severe diarrhoea (more than 6 loose stools per day) or signs of dehydration such as dizziness, dry mouth, or reduced urine output.
- New or worsening cough, shortness of breath, or fever, which may indicate interstitial lung disease.
- Severe skin rash with blisters, peeling skin, or sores in the mouth or eyes.
- Yellowing of the skin or eyes, dark urine, or right upper abdominal pain, which may indicate liver problems.
- Eye pain, redness, blurred vision, or excessive tearing.
- Chest pain, palpitations, or swelling of the legs, which may indicate heart problems.
- Severe abdominal pain with fever or blood in stool, which may indicate gastrointestinal perforation.
- Unusual bruising or bleeding.
- Muscle pain, weakness, or dark urine, which may indicate rhabdomyolysis.
If experiencing severe symptoms, call emergency services immediately.
What is xovoltib 30mg tablet used for?
This medicine is a targeted cancer therapy used to treat EGFR mutation-positive non-small cell lung cancer. It works by blocking specific receptors on cancer cells to slow their growth. It is taken orally once daily under the supervision of a cancer specialist.
- Generic Name: Afatinib dimaleate (30mg)
- Manufacturer: Boehringer Ingelheim
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 xovoltib 30mg tablet के बारे में (Hindi Summary)
उपयोग: यह दवा मुख्य रूप से उन फेफड़ों के कैंसर (नॉन-स्मॉल सेल लंग कैंसर) के इलाज के लिए इस्तेमाल की जाती है, जिनमें EGFR जीन में विशेष म्यूटेशन होता है। यह एक टार्गेटेड थेरेपी है, जो कैंसर कोशिकाओं के विकास को रोकने में मदद करती है। यह दवा मुँह से ली जाती है और डॉक्टर की सलाह से ही लेनी चाहिए। यह कैंसर को पूरी तरह ठीक नहीं करती, लेकिन बीमारी को नियंत्रित करने और जीवन की गुणवत्ता सुधारने में मदद करती है।
साइड इफेक्ट्स: इस दवा के सामान्य दुष्प्रभावों में दस्त, त्वचा पर दाने, मुँह के छाले, नाखूनों में सूजन, भूख कम लगना, जी मिचलाना और थकान शामिल हैं। दस्त गंभीर हो सकते हैं, इसलिए पर्याप्त पानी पिएं। त्वचा पर लाल चकत्ते या छाले होने पर तुरंत डॉक्टर को बताएं। कुछ गंभीर दुष्प्रभाव जैसे फेफड़ों में सूजन, लीवर की समस्या, आंखों में दर्द या धुंधली दृष्टि भी हो सकते हैं, जिनके लिए तत्काल चिकित्सा सहायता लेनी चाहिए।
सुरक्षा सलाह: इस दवा को केवल कैंसर विशेषज्ञ की देखरेख में ही लें। रोज एक ही समय पर दवा लें, खाने के साथ या बिना। अंगूर और अंगूर का जूस न लें, क्योंकि इससे दवा का स्तर बढ़ सकता है। गर्भावस्था के दौरान इस दवा का इस्तेमाल न करें, क्योंकि यह शिशु के लिए हानिकारक हो सकती है। स्तनपान कराने वाली महिलाएं इस दवा का सेवन न करें। दवा लेते समय शराब से बचें। धूप में जाने से बचें और सनस्क्रीन का इस्तेमाल करें। नियमित रूप से डॉक्टर से जांच कराते रहें।
💊 xovoltib 30mg tablet Uses & Benefits
- [{"condition":"EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)","description":"This medicine is used as first-line treatment for patients with locally advanced or metastatic NSCLC whose tumours have certain activating EGFR mutations, such as exon 19 deletions or exon 21 L858R substitution.
- It helps shrink tumours and delay progression.","evidence":"Well-established"},{"condition":"Squamous cell carcinoma of the lung (after platinum-based chemotherapy)","description":"This medicine is approved for patients with advanced squamous NSCLC whose disease has progressed after platinum-based chemotherapy.
- It provides an additional treatment option in this setting.","evidence":"Well-established"},{"condition":"Head and neck cancer (off-label)","description":"Sometimes used off-label in recurrent or metastatic head and neck squamous cell carcinoma, especially in patients with EGFR overexpression.
- Evidence is limited and it is not a standard first-line option.","evidence":"Limited"}]
Off-label uses: [{"condition":"HER2-positive breast cancer","description":"Afatinib has been studied in HER2-positive breast cancer, particularly in combination with other targeted therapies, but it is not approved for this indication. Use is investigational.","evidence":"Limited"},{"condition":"Other EGFR-mutated solid tumours","description":"Rarely, this medicine may be used in other cancers with EGFR mutations, such as certain colorectal or brain tumours, but evidence is very limited and it is not standard practice.","evidence":"Limited"}]
Primary treatment for: EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
Also treats: Squamous cell carcinoma of the lung (after platinum-based chemotherapy), Head and neck cancer (off-label), HER2-positive breast cancer (off-label, investigational)
📋 Drug Information
| Generic Name(s) | Afatinib dimaleate (30mg) |
| Brand Name | xovoltib 30mg tablet |
| Manufacturer | Boehringer Ingelheim |
| 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 15°C and 30°C (59°F to 86°F). Keep the tablets in their original blister pack or bottle, tightly closed, and protect from moisture and light. Do not remove the desiccant from the bottle. Keep out of reach of children and pets. |
| Shelf Life | The shelf life of this medicine is typically 24 to 36 months from the date of manufacture. Refer to the expiry date printed on the packaging. Do not use after the expiry date. |
| 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 works by irreversibly binding to and inhibiting the tyrosine kinase activity of the epidermal growth factor receptor (EGFR) family, which includes EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4. These receptors are involved in signalling pathways that promote cell growth, survival, and division. In certain cancers, mutations or overexpression of these receptors lead to uncontrolled cell proliferation. By blocking these receptors, this medicine interrupts the signalling cascade, leading to reduced cancer cell growth and increased cell death. Because the binding is irreversible, the inhibitory effect lasts until new receptors are synthesised.
Mechanism Steps
💡 How to Take xovoltib 30mg tablet
Strength: This medicine is available as an immediate-release tablet containing 30 mg of afatinib dimaleate. It is also available in other strengths such as 20 mg, 40 mg, and 50 mg.
Dosage Information
| Adult Dosage | The recommended adult dose of this medicine is 40 mg taken orally once daily, but for this 30 mg strength, the dose may be adjusted by the doctor. The typical starting dose for EGFR mutation-positive NSCLC is 40 mg once daily, and for squamous NSCLC after platinum-based chemotherapy, it is also 40 mg once daily. However, the 30 mg tablet is often used when a dose reduction is needed due to side effects. Dose reductions may be made in steps of 10 mg. The maximum daily dose is 50 mg, but this is rarely used. Dose must be individualized by a qualified clinician based on indication, age, weight, renal and hepatic function, and tolerability. Do not change the dose without consulting your doctor. |
| Pediatric Dosage | Pediatric dosing is not established from available information. Consult a pediatric oncologist for guidance. |
| Elderly Dosage | No specific dose adjustment is recommended for elderly patients based on age alone. However, elderly patients may be more sensitive to side effects such as diarrhoea and dehydration. Monitor closely and adjust dose as needed based on tolerability and organ function. |
| Renal Impairment | No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance 30-89 mL/min). For severe renal impairment (creatinine clearance <30 mL/min), caution is advised and dose adjustment may be considered based on clinical judgment. Not established for patients on dialysis. |
| Hepatic Impairment | No dose adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh A or B). For severe hepatic impairment (Child-Pugh C), this medicine should be used with caution and dose adjustment may be necessary. Monitor liver function closely. |
| Maximum Daily Dose | The maximum recommended daily dose is 50 mg, but the usual maximum is 40 mg once daily. Dose reductions to 30 mg or 20 mg may be needed for toxicity. Do not exceed the dose prescribed by your doctor. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of xovoltib 30mg 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 | |
| Rifampicin | Major | |
| Verapamil | Moderate | |
| Omeprazole | Moderate | |
| Warfarin | Minor | |
| Ibuprofen | Minor | |
| St. John's wort | Major | |
| Clarithromycin | Major | |
| Phenytoin | Major | |
| Cyclosporine | Moderate |
🚨 Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir)
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)
- P-glycoprotein (P-gp) inhibitors (e.g., verapamil, quinidine, cyclosporine)
- P-glycoprotein (P-gp) inducers (e.g., rifampicin, St. John's wort)
⚡ Moderate Interactions
- Proton pump inhibitors (e.g., omeprazole)
- H2 receptor antagonists (e.g., ranitidine)
- Antacids
🍷 Alcohol Interaction
Alcohol may worsen some side effects of this medicine, such as nausea, fatigue, and liver stress. It is advisable to avoid or limit alcohol consumption while taking this medicine. Consult your doctor for personalised advice.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Known hypersensitivity to afatinib or any component of the tablet","Pregnancy (due to risk of fetal harm)","Breastfeeding (due to potential serious adverse reactions in infants)","Severe hepatic impairment (Child-Pugh C) without close monitoring","Concomitant use with strong CYP3A4 inducers (unless benefits outweigh risks and dose adjusted)"]
⚠️ Warnings & Precautions
["Diarrhoea: May be severe and lead to dehydration. Monitor and treat promptly.","Skin reactions: May be severe; monitor and manage with appropriate skin care and medications.","Interstitial lung disease: Rare but potentially fatal. Discontinue if suspected.","Hepatotoxicity: Monitor liver function tests. Discontinue if severe.","Cardiotoxicity: Monitor cardiac function in at-risk patients.","Eye disorders: Keratitis may occur. Refer to ophthalmologist if symptoms develop.","Embryo-fetal toxicity: Use effective contraception during treatment and for at least 2 weeks after the last dose.","Lactation: Do not breastfeed during treatment and for at least 2 weeks after the last dose.","Renal impairment: Use with caution in severe renal impairment.","Gastrointestinal perforation: Rare but serious. Discontinue if suspected."]
🤱 Lactation Safety
It is not known whether this medicine is excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment 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, treatment should be symptomatic and supportive. Monitor vital signs and manage any adverse reactions. Contact a poison control centre or emergency department immediately. Haemodialysis is not expected to be effective because afatinib is highly protein-bound.
⏰ Missed Dose
If you miss a dose and it is more than 12 hours until your next scheduled dose, take the missed dose as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.
Additional Safety Advice
This medicine must only be taken under the supervision of a qualified cancer specialist. Do not start, stop, or change the dose without consulting your doctor. Take the tablet at the same time each day, with or without food, but avoid grapefruit and grapefruit juice as they can increase the amount of medicine in your body. If you miss a dose and it is more than 12 hours until your next scheduled dose, take it as soon as you remember; if it is less than 12 hours, skip the missed dose and continue with your regular schedule. Do not double the dose. Because this medicine can cause diarrhoea and skin problems, your doctor will monitor you regularly with blood tests and physical examinations. Use effective contraception during treatment and for at least 2 weeks after the last dose if you are of childbearing potential. Do not breastfeed while taking this medicine. Avoid prolonged sun exposure and use sunscreen, as this medicine can make your skin more sensitive to sunlight. Inform all your healthcare providers, including your dentist, that you are taking this medicine before any procedure. Keep this medicine out of the reach of children and store it as directed on the label.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients (above 65 years) may be more sensitive to the side effects of this medicine, especially diarrhoea and dehydration. Close monitoring is recommended. Dose adjustment may be needed based on tolerability and organ function. Falls and fatigue should be managed carefully.
🤰 Pregnancy Planning (TTC)
This medicine can cause harm to the unborn baby. Women of childbearing potential should use effective contraception during treatment and for at least 2 weeks after the last dose. If you are planning to become pregnant, discuss with your doctor before stopping contraception. Men with female partners of childbearing potential should also use effective contraception during treatment and for at least 2 weeks after the last dose.
🏥 Post-Surgery Considerations
If you are scheduled for surgery, inform your surgeon and anaesthesiologist that you are taking this medicine. It may need to be stopped temporarily before surgery due to the risk of impaired wound healing and bleeding. Your doctor will advise you on when to stop and when to restart.
🦷 Dental Procedures
Inform your dentist that you are taking this medicine before any dental procedure. This medicine can cause mouth sores and may affect healing. Your dentist may recommend postponing non-urgent procedures until your blood counts and overall condition are stable. Maintain good oral hygiene to reduce the risk of complications.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
This medicine may cause fatigue, dizziness, or eye problems that could affect your ability to exercise safely. Avoid strenuous activities if you feel unwell. Consult your doctor before starting any new exercise programme. Light activities such as walking may be beneficial, but listen to your body and rest when needed.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause fatigue, diarrhoea, skin rash, and eye problems, which can affect your ability to work and perform daily activities. You may need to take time off or adjust your work schedule during treatment. Driving and operating machinery should be avoided if you feel tired or have vision problems. Discuss with your employer about flexible working arrangements if needed. Emotional support and counselling can help cope with the impact of cancer treatment.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your doctor. Your doctor may decide to stop treatment if the disease progresses, if you experience unacceptable side effects, or if you develop certain serious conditions such as interstitial lung disease. If you need to stop, your doctor will guide you on how to do so safely and may discuss alternative treatments.
📅 Long-Term Use Effects
Long-term use of this medicine may lead to persistent side effects such as skin rash, diarrhoea, and fatigue. Regular monitoring of liver, kidney, and heart function is required. Some patients may develop resistance to the medicine over time, leading to disease progression. Long-term use may also increase the risk of rare but serious side effects. Your doctor will regularly assess the benefits and risks of continuing treatment.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
These are alternative targeted therapies for EGFR-mutated lung cancer. Your doctor may choose one based on your specific mutation and medical history.
Evidence: Well-establishedTraditional chemotherapy may be used alone or in combination with targeted therapy, depending on the stage and type of cancer.
Evidence: Well-establishedImmune checkpoint inhibitors may be an option for some patients with lung cancer, but they are generally less effective in EGFR-mutated tumours.
Evidence: Well-established for certain indicationsParticipation in clinical trials may provide access to new and investigational treatments.
Evidence: Varies💉 Vaccination Considerations
💉 If You're Getting Vaccinated
Live vaccines should be avoided while taking this medicine because it may weaken the immune system. Inactivated vaccines are generally safe, but consult your doctor before receiving any vaccine. Timing of vaccination should be discussed with your oncologist.
📦 Storage Guide
✅ DO
Store at room temperature between 15°C and 30°C.
❌ DON'T
Do not refrigerate or freeze.
✅ DO
Keep in the original blister pack or bottle, tightly closed.
❌ DON'T
Do not transfer to another container.
✅ DO
Protect from moisture and light.
❌ DON'T
Do not store in the bathroom.
✅ DO
Keep out of reach of children and pets.
❌ DON'T
Do not use after the expiry date.
✈️ Traveling with This Medicine
When travelling, carry this medicine in its original packaging with the prescription label clearly visible. Bring a copy of your prescription and a doctor's letter explaining that you need this medicine for cancer treatment. Keep the medicine in your carry-on luggage to avoid loss or temperature extremes. Store at room temperature and protect from moisture. If crossing time zones, consult your doctor about how to adjust the timing of your dose. Check the customs regulations of your destination country regarding controlled or prescription medicines. Carry enough supply for your entire trip and a little extra in case of delays.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: It may take several weeks to months before you notice improvement. Your doctor will assess response with regular scans and tests.
A: Yes, you can take it with or without food. However, avoid grapefruit and grapefruit juice.
A: If it is more than 12 hours until your next dose, take it as soon as you remember. If it is less than 12 hours, skip the missed dose and continue with your regular schedule. Do not double dose.
A: The most common side effects are diarrhoea, skin rash, dry skin, mouth sores, and fatigue. These can usually be managed with supportive care.
A: No, this medicine can harm the unborn baby. It is contraindicated during pregnancy. Use effective contraception during treatment and for at least 2 weeks after the last dose.
A: It is best to avoid or limit alcohol as it may worsen side effects such as nausea, fatigue, and liver stress.
A: Store at room temperature between 15°C and 30°C in the original packaging, protected from moisture and light. Keep out of reach of children.
A: No, do not stop without consulting your doctor. Stopping early can lead to disease progression.
A: Watch for severe diarrhoea, new or worsening cough or breathlessness, severe skin reactions, yellowing of eyes or skin, eye pain, chest pain, and severe abdominal pain. Seek immediate medical attention if these occur.
A: Yes, it can interact with several medicines, including strong CYP3A4 inhibitors and inducers, and P-gp inhibitors. Always inform your doctor about all medicines you are taking.
🤔 Common Patient Concerns
🔄 Substitutes for xovoltib 30mg tablet
View AllAlternative brands with exact same active ingredient:
-
afmed 30mg tabletMedicamen Biotech Ltd ₹4,134.38 68.9% CHEAPER
-
afzeta 30mg tabletSun Pharmaceutical Industries Ltd ₹4,155.00 68.7% CHEAPER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: This medicine is a traditional chemotherapy that causes severe hair loss.
Fact: This medicine is a targeted therapy, not traditional chemotherapy. Hair loss is not a common side effect. It mainly causes skin rash and diarrhoea. - Myth: This medicine can cure lung cancer completely.
Fact: This medicine can control the disease and improve survival, but it is not a cure. It is used to slow progression and manage symptoms. - Myth: You can stop taking this medicine once you feel better.
Fact: You must continue taking this medicine as prescribed by your doctor. Stopping early can lead to disease progression. - Myth: This medicine is safe to take during pregnancy.
Fact: This medicine can harm the unborn baby. It is contraindicated during pregnancy, and effective contraception is required.