Afzeta 30mg Tablet (Afatinib Dimaleate) - 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 diarrhea with dehydration, dizziness, or decreased urination
- New or worsening cough, shortness of breath, or fever
- Painful skin rash with blisters or peeling, especially with mouth sores
- Yellowing of skin or eyes, dark urine, or severe abdominal pain
- Eye pain, redness, blurred vision, or excessive tearing
- Severe abdominal pain with fever or changes in bowel habits
- Unusual bleeding or bruising
- Swelling of face, lips, or throat
If experiencing severe symptoms, call emergency services immediately.
What is afmed 30mg 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
- Manufacturer: Medicamen Biotech Ltd
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 afmed 30mg tablet के बारे में (Hindi Summary)
उपयोग: यह दवा मुख्य रूप से फेफड़ों के कैंसर (नॉन-स्मॉल सेल लंग कैंसर) के इलाज के लिए इस्तेमाल की जाती है, खासकर उन मरीजों में जिनके ट्यूमर में EGFR जीन में म्यूटेशन होता है। यह एक टार्गेटेड थेरेपी है जो कैंसर कोशिकाओं की वृद्धि को रोकती है। यह मुंह से ली जाती है और आमतौर पर दिन में एक बार ली जाती है। यह दवा कैंसर विशेषज्ञ की देखरेख में ही लेनी चाहिए।
साइड इफेक्ट्स: इस दवा के आम दुष्प्रभावों में दस्त, त्वचा पर दाने, मुंह के छाले, नाखूनों में बदलाव, भूख कम लगना, जी मिचलाना और थकान शामिल हैं। कुछ गंभीर दुष्प्रभाव भी हो सकते हैं जैसे गंभीर दस्त, निर्जलीकरण, फेफड़ों में सूजन, लीवर की समस्या, आंखों की समस्या और त्वचा पर गंभीर प्रतिक्रियाएं। अगर कोई भी गंभीर लक्षण दिखे तो तुरंत डॉक्टर से संपर्क करें।
सुरक्षा सलाह: इस दवा को डॉक्टर के बताए अनुसार ही लें। दिन में एक बार नियमित समय पर लें। दस्त होने पर पानी और तरल पदार्थ का सेवन अधिक करें। धूप से बचें और सनस्क्रीन का इस्तेमाल करें। गर्भवती महिलाएं या गर्भधारण की योजना बना रही महिलाएं इस दवा का सेवन न करें। स्तनपान कराने वाली महिलाएं भी इस दवा का सेवन न करें। अन्य दवाओं के साथ इस दवा का सेवन करने से पहले डॉक्टर से सलाह लें। नियमित रूप से लीवर और किडनी की जांच कराते रहें।
💊 afmed 30mg tablet Uses & Benefits
[{"condition":"EGFR mutation-positive non-small cell lung cancer (NSCLC)","description":"Used as first-line treatment in patients with locally advanced or metastatic NSCLC whose tumors have certain EGFR mutations (e.g., exon 19 deletions or exon 21 L858R substitution).","evidence":"Well-established"},{"condition":"Squamous cell carcinoma of the lung","description":"Used in patients with advanced squamous NSCLC that has progressed after platinum-based chemotherapy.","evidence":"Established"},{"condition":"HER2-positive breast cancer","description":"Used in combination with other agents in certain patients with HER2-positive metastatic breast cancer after prior treatments.","evidence":"Limited"},{"condition":"Head and neck cancer","description":"Sometimes used in clinical trials or off-label for recurrent or metastatic head and neck squamous cell carcinoma.","evidence":"Investigational"}]
Off-label uses: [{"condition":"Other EGFR-mutated solid tumors","description":"Occasionally used off-label for other cancers with EGFR mutations, such as glioblastoma or colorectal cancer, based on molecular profiling.","evidence":"Limited"}]
Primary treatment for: EGFR mutation-positive non-small cell lung cancer (NSCLC)
Also treats: Squamous cell carcinoma of the lung, HER2-positive breast cancer
📋 Drug Information
| Generic Name(s) | Afatinib |
| Brand Name | Afzeta 30mg Tablet |
| Manufacturer | Medicamen Biotech 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). Excursions permitted to 15°C to 30°C (59°F to 86°F). Keep in the original container to protect from moisture and light. Do not remove the desiccant. Keep out of reach of children. |
| Shelf Life | Refer to the expiration date printed on the package. 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 ErbB family of receptor tyrosine kinases, including EGFR (ErbB1), HER2 (ErbB2), ErbB3, and ErbB4. It covalently binds to the ATP-binding site of these receptors, leading to irreversible inhibition of autophosphorylation and downstream signaling. This results in inhibition of cell proliferation, induction of apoptosis, and reduction of angiogenesis and metastasis. The irreversible binding distinguishes it from reversible inhibitors and may lead to prolonged effects.
Mechanism Steps
💡 How to Take afmed 30mg tablet
Strength: This medicine is available as a 30 mg immediate-release tablet for oral administration.
Dosage Information
| Adult Dosage | The recommended adult dose of this medicine is 40 mg orally once daily for first-line treatment of EGFR mutation-positive non-small cell lung cancer. For squamous NSCLC after platinum-based chemotherapy, the recommended dose is 40 mg once daily. For HER2-positive breast cancer, the dose may be 40 mg once daily with other agents. Dose reductions to 30 mg or 20 mg may be required for adverse reactions. Dose must be individualized by a qualified clinician based on indication, age, weight, 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 based on age alone. However, elderly patients may be more susceptible to adverse effects such as diarrhea and dehydration. Monitor closely and adjust dose as needed based on tolerability and organ function. |
| Renal Impairment | For patients with severe renal impairment (creatinine clearance <30 mL/min), the recommended dose is 30 mg once daily. For moderate renal impairment (creatinine clearance 30-59 mL/min), no initial dose adjustment is required, but monitor closely. For mild renal impairment, no adjustment is needed. |
| Hepatic Impairment | For patients with severe hepatic impairment (Child-Pugh C), the recommended dose is 30 mg once daily. For moderate hepatic impairment (Child-Pugh B), no initial dose adjustment is required, but monitor closely. For mild hepatic impairment, no adjustment is needed. |
| Maximum Daily Dose | The maximum recommended daily dose is 40 mg once daily. Dose reductions may be necessary for toxicity. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of afmed 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 |
|---|---|---|
| Ritonavir | Major | |
| Rifampicin | Major | |
| Ketoconazole | Major | |
| Cyclosporine | Major | |
| Verapamil | Major | |
| Carbamazepine | Major | |
| Phenytoin | Major | |
| St. John's wort | Major | |
| Omeprazole | Moderate | |
| Ranitidine | Moderate |
🚨 Major Interactions
- P-glycoprotein (P-gp) inhibitors (e.g., ritonavir, cyclosporine, ketoconazole, itraconazole, quinidine, verapamil)
- P-glycoprotein (P-gp) inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)
⚡ Moderate Interactions
- Proton pump inhibitors (e.g., omeprazole)
- H2 receptor antagonists (e.g., ranitidine)
🍷 Alcohol Interaction
Alcohol may worsen side effects such as nausea, dizziness, and fatigue. 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 severe hypersensitivity to afatinib or any component of the formulation","Pregnancy (due to risk of fetal harm)","Breastfeeding (due to potential serious adverse reactions in infants)","Severe hepatic impairment (Child-Pugh C) without dose adjustment","Severe renal impairment (creatinine clearance
⚠️ Warnings & Precautions
["Diarrhea: May be severe and lead to dehydration, renal failure, and electrolyte imbalances. Monitor and treat promptly.","Skin reactions: Severe bullous, blistering, and exfoliative skin disorders have occurred. Discontinue if life-threatening.","Interstitial lung disease (ILD): Has been reported; discontinue if ILD is suspected.","Hepatotoxicity: Monitor liver function; dose interruption or discontinuation may be required.","Gastrointestinal perforation: Has been reported; discontinue if suspected.","Ocular disorders: Keratitis and conjunctivitis have been reported; refer to ophthalmologist if symptoms occur.","Embryo-fetal toxicity: Can cause fetal harm; advise contraception.","Renal impairment: Dose adjustment needed for severe renal impairment.","P-gp interactions: Avoid concomitant use with strong P-gp inhibitors or inducers; adjust dose if necessary."]
🤱 Lactation Safety
It is not known whether afatinib 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, treatment should be symptomatic and supportive. Gastric lavage may be considered if ingestion is recent. Monitor vital signs and provide appropriate supportive care. 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
This medicine must be taken exactly as prescribed by your oncologist. Do not adjust the dose without consulting your doctor. Take it at the same time each day, with or without food. If you miss a dose, take it as soon as you remember, but if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose. Diarrhea is a common side effect; your doctor may prescribe anti-diarrheal medicines and advise you to drink plenty of fluids. Report any signs of severe diarrhea, rash, or breathing difficulties immediately. Avoid prolonged sun exposure and use sunscreen, as this medicine can make your skin sensitive to sunlight. Use effective contraception during treatment and for at least two weeks after the last dose, as this medicine can harm a developing baby. Do not breastfeed while taking this medicine. Inform your doctor about all other medicines you are taking, including over-the-counter drugs and herbal supplements, as many can interact with this medicine. Regular blood tests to check liver and kidney function, as well as eye examinations, may be needed. Store this medicine 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 sensitive to the side effects of this medicine, especially diarrhea and dehydration. Close monitoring and dose adjustments may be necessary. Ensure adequate fluid intake and monitor kidney function.
🤰 Pregnancy Planning (TTC)
This medicine can cause harm to a developing fetus. 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 the 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
If you are planning surgery, inform your surgeon and oncologist 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 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 elective procedures until your mouth sores have healed. Good oral hygiene is important.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
Mild to moderate exercise is generally safe, but if you experience fatigue, dizziness, or diarrhea, avoid strenuous activities. Consult your doctor before starting any new exercise regimen.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause fatigue, diarrhea, and skin rash, which can affect your ability to work or perform daily activities. If you experience dizziness or severe diarrhea, avoid driving or operating heavy machinery. Discuss with your employer about flexible work arrangements if needed.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your doctor. Your doctor may decide to stop treatment if the cancer progresses or if you experience unacceptable side effects. If you need to stop for any reason, your doctor will provide guidance on monitoring and alternative treatments.
📅 Long-Term Use Effects
Long-term use of this medicine may lead to chronic side effects such as persistent diarrhea, skin changes, and nail abnormalities. Regular monitoring of liver, kidney, and lung function is necessary. Some patients may develop resistance to the medicine over time, requiring a change in treatment. Long-term effects on fertility are not fully known. Discuss any concerns with your oncologist.
🌿 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 effective or not tolerated.
Evidence: Well-establishedImmune checkpoint inhibitors may be an option for some patients, but not typically for EGFR-mutated tumors.
Evidence: Limited💉 Vaccination Considerations
💉 If You're Getting Vaccinated
Live vaccines should be avoided while taking this medicine due to the potential for increased risk of infection. Inactivated vaccines may be given, but their effectiveness may be reduced. Consult your doctor before receiving any vaccinations.
📦 Storage Guide
✅ DO
Store at room temperature (20-25°C)
❌ DON'T
Do not refrigerate
✅ DO
Keep in original container with desiccant
❌ DON'T
Do not transfer to another container
✅ DO
Keep away from moisture and heat
❌ DON'T
Do not store in bathroom
✅ DO
Keep out of reach of children
❌ DON'T
Do not use after 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 doctor's letter explaining your medical condition and the need for this medicine. Keep it in your carry-on luggage to avoid loss or temperature extremes. Store at room temperature and protect from moisture. If crossing time zones, continue taking your dose at the same time each day according to your home schedule, or adjust as advised by your doctor. Check customs regulations for carrying prescription medicines in your destination country.
💰 Cost Analysis & Savings
👥 Real Patient Stories
Educational, anonymized scenarios. Individual results may vary.
💬 Questions Patients Often Ask
A: This medicine starts working on cancer cells soon after you begin taking it, but noticeable tumor shrinkage may take several weeks to months. Your doctor will monitor your response with regular scans.
A: Yes, you can take this medicine with or without food. However, avoid grapefruit juice as it can increase the levels of this medicine in your body.
A: Diarrhea is common. Start anti-diarrheal medication as advised by your doctor, drink plenty of fluids, and if it persists or is severe, contact your doctor immediately.
A: No, this medicine is a targeted therapy, not traditional chemotherapy. It specifically blocks proteins that drive cancer cell growth.
A: No, you should continue taking this medicine exactly as prescribed until your doctor tells you to stop. Stopping early may allow the cancer to grow back.
🤔 Common Patient Concerns
🔄 Substitutes for afmed 30mg tablet
View AllAlternative brands with exact same active ingredient:
-
afzeta 30mg tabletSun Pharmaceutical Industries Ltd ₹4,155.00 0.5% COSTLIER
-
xovoltib 30mg tabletBoehringer Ingelheim ₹13,272.66 221% COSTLIER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: Afatinib is a traditional chemotherapy that causes severe hair loss.
Fact: Afatinib is a targeted therapy, not traditional chemotherapy. Hair loss is uncommon; it primarily causes skin and gastrointestinal side effects. - Myth: Afatinib can be taken by anyone with lung cancer.
Fact: Afatinib is only effective for cancers with specific EGFR mutations. Genetic testing is required before use. - Myth: You can stop taking afatinib once you feel better.
Fact: Afatinib should be continued as prescribed until your doctor advises otherwise, even if you feel better, to keep the cancer under control.