Xovoltib 20mg 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 or vomiting leading to dehydration
- New or worsening cough, shortness of breath, or fever
- Yellowing of skin or eyes, dark urine, or abdominal pain
- Eye pain, redness, blurred vision, or excessive tearing
- Severe skin rash with blisters or peeling
- Sudden severe abdominal pain, fever, and chills
- Unusual bleeding or bruising
- Swelling of face, lips, or throat
If experiencing severe symptoms, call emergency services immediately.
What is xovoltib 20mg tablet used for?
This medicine is a targeted therapy used to treat non-small cell lung cancer with specific EGFR mutations. It works by blocking proteins that help cancer cells grow. It is taken orally once daily.
- Generic Name: Afatinib dimaleate (20mg)
- Manufacturer: Boehringer Ingelheim
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 xovoltib 20mg tablet के बारे में (Hindi Summary)
उपयोग: यह दवा एफिनिब (afatinib) नामक सक्रिय तत्व से बनी है और यह 20 मिलीग्राम की गोली के रूप में उपलब्ध है। यह मुख्य रूप से उन फेफड़ों के कैंसर (नॉन-स्मॉल सेल लंग कैंसर) के इलाज के लिए दी जाती है जिनमें EGFR जीन में विशिष्ट उत्परिवर्तन (म्यूटेशन) होता है। यह दवा कैंसर कोशिकाओं के विकास को रोकने में मदद करती है। यह केवल योग्य कैंसर विशेषज्ञ (ऑन्कोलॉजिस्ट) की देखरेख में ही ली जानी चाहिए।
साइड इफेक्ट्स: आम दुष्प्रभावों में दस्त, दाने, सूखी त्वचा, मुँह के छाले और नाखूनों में बदलाव शामिल हैं। गंभीर दुष्प्रभावों में गंभीर दस्त, निर्जलीकरण, फेफड़ों में सूजन, यकृत की समस्या और आंखों की समस्या हो सकती है। यदि आपको गंभीर दस्त, उल्टी, या निर्जलीकरण के लक्षण महसूस हों तो तुरंत डॉक्टर से संपर्क करें।
सुरक्षा सलाह: इस दवा को डॉक्टर के बताए अनुसार ही लें। गोली को पानी के साथ पूरा निगलें, चबाएं नहीं। इसे भोजन के साथ या बिना भोजन के ले सकते हैं, लेकिन हर दिन एक ही समय पर लें। चकोतरा (ग्रेपफ्रूट) और उसके जूस से बचें। अन्य दवाओं के बारे में डॉक्टर को बताएं। गर्भावस्था और स्तनपान के दौरान इस दवा का सेवन न करें। इसे बच्चों की पहुंच से दूर रखें।
💊 xovoltib 20mg tablet Uses & Benefits
[{"condition":"EGFR mutation-positive non-small cell lung cancer (NSCLC)","description":"First-line treatment for patients with locally advanced or metastatic NSCLC whose tumours have activating EGFR mutations (e.g., exon 19 deletions or exon 21 L858R substitution).","evidence":"Well-established"},{"condition":"Squamous cell carcinoma of the lung","description":"Treatment of patients with advanced squamous NSCLC that has progressed after platinum-based chemotherapy.","evidence":"Well-established"},{"condition":"Head and neck squamous cell carcinoma","description":"Sometimes used off-label for recurrent or metastatic head and neck cancer.","evidence":"Limited"}]
Off-label uses: [{"condition":"HER2-positive breast cancer","description":"Investigated in clinical trials for HER2-positive breast cancer, but not approved for this indication.","evidence":"Limited"},{"condition":"Other EGFR-mutated cancers","description":"Occasionally used in other cancers with EGFR mutations, such as glioblastoma, but evidence is limited.","evidence":"Limited"}]
Primary treatment for: EGFR mutation-positive non-small cell lung cancer (NSCLC)
Also treats: Squamous cell carcinoma of the lung
📋 Drug Information
| Generic Name(s) | Afatinib dimaleate (20mg) |
| Brand Name | xovoltib 20mg 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 20°C and 25°C (68°F to 77°F). Keep in the original container to protect from moisture and light. Do not refrigerate or freeze. |
| Shelf Life | Refer to the packaging for the expiry date. 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 is an irreversible inhibitor of the epidermal growth factor receptor (EGFR) family, including EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4. It binds covalently to the ATP-binding site of these receptors, leading to irreversible inhibition of tyrosine kinase activity. This blocks autophosphorylation and downstream signalling pathways that promote cell proliferation, survival, and metastasis. By inhibiting these pathways, this medicine helps to slow or stop the growth of cancer cells that overexpress or have mutations in these receptors.
Mechanism Steps
💡 How to Take xovoltib 20mg tablet
Strength: 20 mg immediate-release tablet
Dosage Information
| Adult Dosage | The recommended dose of this medicine is 40 mg orally once daily for first-line treatment of EGFR mutation-positive NSCLC. For squamous NSCLC after platinum-based chemotherapy, the recommended dose is 40 mg once daily. For patients with severe renal impairment, the dose may be reduced to 30 mg once daily. Dose adjustments may be necessary for adverse reactions. The dose must be individualized by a qualified clinician based on indication, patient's condition, renal and hepatic function, and tolerability. |
| 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 susceptible to dehydration and renal impairment from diarrhoea. Monitor closely and adjust dose as needed based on tolerability and organ function. |
| Renal Impairment | For patients with severe renal impairment (creatinine clearance 15-29 mL/min), the recommended dose is 30 mg once daily. For patients with end-stage renal disease requiring dialysis, the dose is not established. Use with caution and monitor closely. |
| Hepatic Impairment | No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. This medicine is not recommended for patients with severe (Child-Pugh C) hepatic impairment. |
| Maximum Daily Dose | The maximum recommended daily dose is 40 mg once daily. In case of severe renal impairment, the maximum dose is 30 mg once daily. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of xovoltib 20mg 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 | |
| Ranitidine | Moderate | |
| Antacids | Minor | |
| Warfarin | Moderate | |
| CYP3A4 inducers (e.g., carbamazepine) | Major | |
| CYP3A4 inhibitors (e.g., ritonavir) | Major | |
| P-gp inhibitors (e.g., quinidine) | Moderate |
🚨 Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin)
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin)
- P-glycoprotein inhibitors (e.g., verapamil, quinidine)
⚡ Moderate Interactions
- Proton pump inhibitors (e.g., omeprazole)
- H2 receptor antagonists (e.g., ranitidine)
🍷 Alcohol Interaction
Alcohol may increase the risk of liver toxicity and gastrointestinal side effects. It is advisable to avoid or limit alcohol consumption while taking this medicine.
🔎 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 formulation.","Severe hepatic impairment (Child-Pugh C).","Severe renal impairment (creatinine clearance
⚠️ Warnings & Precautions
["Diarrhoea: May be severe and lead to dehydration, renal failure, and electrolyte imbalances. Monitor and treat promptly.","Skin reactions: Severe bullous, blistering, or exfoliative skin conditions have been reported. Discontinue if life-threatening.","Interstitial lung disease (ILD): May be fatal. Discontinue if ILD is suspected.","Hepatotoxicity: Monitor liver function. Discontinue if severe.","Ocular disorders: Keratitis may occur. Refer to ophthalmologist if symptoms develop.","Gastrointestinal perforation: Discontinue if suspected.","Cardiac toxicity: Monitor LVEF in at-risk patients.","Embryo-fetal toxicity: Use effective contraception. Avoid pregnancy during treatment."]
🤱 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 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 treat symptoms as they occur. Gastric lavage may be considered if ingestion is recent. Contact a poison control center or emergency department immediately.
⏰ Missed Dose
If you miss a dose, take it as soon as you remember. 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.
Additional Safety Advice
Take this medicine exactly as prescribed by your oncologist. Do not change the dose or stop taking it without consulting your doctor. Swallow the tablet whole with a glass of water; do not crush or chew it. You can take it with or without food, but taking it with food may help reduce stomach upset. If you miss a dose, take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose. Avoid grapefruit and grapefruit juice while taking this medicine, as it can increase the levels of the medicine in your body. Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements. Use effective contraception during treatment and for at least two weeks after the last dose, as this medicine can harm an unborn baby. Do not breastfeed while taking this medicine. Store at room temperature away from moisture and heat. Keep out of reach of children.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients may be more susceptible to dehydration and renal impairment from diarrhoea. Monitor closely and adjust dose based on tolerability and organ function. No specific dose adjustment is recommended based on age alone.
🤰 Pregnancy Planning (TTC)
This medicine can harm an 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 starting this medicine. 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
This medicine may affect wound healing and increase the risk of bleeding. Inform your surgeon that you are taking this medicine before any surgery. Your doctor may advise you to stop the medicine temporarily before and after surgery.
🦷 Dental Procedures
This medicine can cause mouth sores and increase the risk of bleeding. Inform your dentist that you are taking this medicine before any dental procedure. Good oral hygiene is important to prevent infections.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
This medicine may cause fatigue, dizziness, or eye problems that could affect your ability to exercise. Avoid strenuous activities until you know how the medicine affects you. Consult your doctor before starting any new exercise regimen.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause fatigue, diarrhoea, and skin rash, which can affect your daily activities and work. You may need to take time off or adjust your schedule. Driving may be affected if you experience fatigue or vision problems. Discuss any work-related concerns with your doctor.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your doctor. If you experience severe side effects, your doctor may temporarily stop the medicine or reduce the dose. Stopping suddenly may cause the cancer to grow. Always follow your doctor's instructions.
📅 Long-Term Use Effects
Long-term use of this medicine may lead to chronic side effects such as persistent diarrhoea, skin changes, and nail problems. Regular monitoring of liver, kidney, and heart function is necessary. Some patients may develop resistance to the medicine over time, requiring a change in treatment. It is important to attend all follow-up appointments and report any new symptoms.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
Erlotinib, gefitinib, or osimertinib may be alternatives based on mutation type and prior treatments.
Evidence: Well-establishedPlatinum-based chemotherapy may be used if targeted therapy is not suitable or stops working.
Evidence: Well-establishedImmune checkpoint inhibitors may be an option for some patients with lung cancer.
Evidence: Well-established💉 Vaccination Considerations
💉 If You're Getting Vaccinated
Live vaccines should be avoided while taking this medicine due to the risk of infection. Inactivated vaccines may be given, but consult your doctor first. Ensure all age-appropriate vaccinations are up to date before starting treatment.
📦 Storage Guide
✅ DO
Store at room temperature (20-25°C)
❌ DON'T
Do not refrigerate or freeze
✅ DO
Keep in original container
❌ DON'T
Do not transfer to unmarked containers
✅ DO
Keep away from direct sunlight and moisture
❌ DON'T
Do not store in bathroom cabinet
✈️ Traveling with This Medicine
Carry this medicine in its original packaging with a copy of your prescription. Keep it in your carry-on luggage to avoid loss or temperature extremes. If crossing time zones, adjust dosing times gradually in consultation with your doctor. Store at room temperature and avoid direct sunlight. Check customs regulations for carrying prescription medicines.
💰 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 to see the full effect. Your doctor will monitor your response with regular scans.
A: Yes, you can take it with or without food, but be consistent. Avoid grapefruit and grapefruit juice.
A: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
A: No, this medicine can harm an unborn baby. Use effective contraception during treatment and for at least 2 weeks after the last dose. Do not breastfeed while taking this medicine.
🤔 Common Patient Concerns
🔄 Substitutes for xovoltib 20mg tablet
View AllAlternative brands with exact same active ingredient:
-
afmed 20mg tabletMedicamen Biotech Ltd ₹2,868.75 94.4% CHEAPER
-
afanat 20 tabletNatco Pharma Ltd ₹2,906.00 94.4% CHEAPER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: This medicine can cure lung cancer completely.
Fact: This medicine can slow or stop cancer growth but does not cure cancer. It is used to control the disease and improve quality of life. - Myth: I can stop taking this medicine once I feel better.
Fact: You should not stop taking this medicine without consulting your doctor. Stopping suddenly may cause the cancer to grow back. - Myth: This medicine has no side effects.
Fact: This medicine can cause side effects, some of which may be serious. Regular monitoring and reporting of symptoms are important.