Bretolap Tablet (Lapatinib 250mg): Complete Guide to Uses, Side Effects, and Safety
Clinical Reference Standards: CDSCO (Central Drugs Standard Control Organisation), Indian Pharmacopoeia (IP) & WHO | Last Updated: September 2026
When to Call Your Doctor IMMEDIATELY
- More than six loose stools in a day or diarrhea that does not improve with treatment.
- Yellowing of the eyes or skin, dark urine, or right upper abdominal pain.
- Shortness of breath, swelling of the legs, or sudden weight gain.
- Chest pain, palpitations, or fainting.
- Severe skin rash with blistering or peeling.
- New or worsening cough, fever, or difficulty breathing.
- Fever with chills or sore throat suggesting infection.
- Unusual bleeding or bruising.
- Severe headache with confusion or vision changes.
- Inability to eat or drink, or signs of dehydration such as dizziness or reduced urine output.
If experiencing severe symptoms, call emergency services immediately.
What is bretolap tablet used for?
This medicine is a targeted anticancer tablet containing lapatinib 250 mg. It is used for HER2-positive metastatic breast cancer in combination with other medicines. It works by blocking EGFR and HER2 receptors on cancer cells. It can cause diarrhea, rash, liver problems, and heart problems, so regular monitoring is essential.
- Generic Name: Lapatinib
- Manufacturer: Alkem Laboratories Ltd
- Form: Allopathy
- Pregnancy Category: Consult doctor
- Prescription Required: Yes
🇮🇳 bretolap tablet के बारे में (Hindi Summary)
उपयोग: यह दवा लैपेटिनिब 250 मिलीग्राम की एक टैबलेट है जिसका उपयोग HER2-पॉजिटिव मेटास्टेटिक ब्रेस्ट कैंसर के इलाज में किया जाता है। यह एक टार्गेटेड कैंसर थेरेपी है जो कैंसर कोशिकाओं में EGFR और HER2 रिसेप्टर्स को ब्लॉक करती है, जिससे कैंसर कोशिकाओं की वृद्धि रुकती है। यह दवा अकेले नहीं, बल्कि कैपेसिटाबिन या लेट्रोज़ोल जैसी अन्य दवाओं के साथ दी जाती है। यह दवा केवल कैंसर रोग विशेषज्ञ की देखरेख में ही लेनी चाहिए। इसे गर्भवती महिलाओं, स्तनपान कराने वाली महिलाओं और गंभीर लिवर रोग वाले मरीजों को नहीं लेना चाहिए।
साइड इफेक्ट्स: इस दवा के सामान्य दुष्प्रभावों में दस्त, जी मिचलाना, उल्टी, त्वचा पर दाने, मुँह के छाले, थकान, भूख न लगना और सिरदर्द शामिल हैं। दस्त गंभीर हो सकते हैं और शरीर में पानी की कमी कर सकते हैं, इसलिए इन्हें तुरंत डॉक्टर को बताना चाहिए। कुछ मरीजों में हाथ-पैर सिंड्रोम हो सकता है जिसमें हथेलियों और तलवों पर लालिमा, सूजन और दर्द होता है। लिवर की जाँच और दिल की जाँच नियमित रूप से करानी चाहिए क्योंकि यह दवा लिवर और हृदय को नुकसान पहुँचा सकती है।
सुरक्षा सलाह: यह दवा केवल कैंसर रोग विशेषज्ञ की सलाह से ही लें। दवा की खुराक खुद से कम या ज्यादा न करें। इसे हर दिन एक ही समय पर लें, खाने के साथ या बिना खाने के, लेकिन अंगूर या अंगूर के जूस के साथ कभी न लें। टैबलेट को पानी के साथ पूरा निगलें, चबाएं या तोड़ें नहीं। दस्त होने पर ओआरएस का घोल पिएं और अगर एक दिन में चार से ज्यादा बार दस्त हों तो डॉक्टर को बताएं। इलाज के दौरान गर्भधारण से बचें और स्तनपान न कराएं। लिवर, दिल और खून की नियमित जाँच कराते रहें। अगर आँखों या त्वचा का रंग पीला पड़े, पेशाब गहरा हो, सांस फूले या पैरों में सूजन आए तो तुरंत डॉक्टर से मिलें।
💊 bretolap tablet Uses & Benefits
[{"condition":"HER2-positive metastatic breast cancer","description":"Used in combination with capecitabine for patients with advanced or metastatic HER2-positive breast cancer who have received prior therapy including an anthracycline, a taxane, and trastuzumab.","evidence":"Well-established"},{"condition":"Hormone receptor-positive, HER2-positive metastatic breast cancer","description":"Used in combination with letrozole for postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses HER2 and for whom hormonal therapy is indicated.","evidence":"Well-established"},{"condition":"HER2-positive inflammatory breast cancer","description":"Sometimes used as part of a treatment plan for inflammatory breast cancer that is HER2-positive, though this is less common and depends on the clinical situation.","evidence":"Limited"}]
Off-label uses: [{"condition":"Other HER2-positive solid tumors","description":"Occasionally used off-label in HER2-positive cancers such as gastric or gastroesophageal junction cancer, but this is not a standard approved use.","evidence":"Limited"},{"condition":"EGFR-overexpressing tumors","description":"Rarely used off-label in some EGFR-driven cancers, but evidence is not strong enough for routine use.","evidence":"Limited"}]
Primary treatment for: HER2-positive metastatic breast cancer
Also treats: Hormone receptor-positive, HER2-positive metastatic breast cancer, HER2-positive inflammatory breast cancer
📋 Drug Information
| Generic Name(s) | Lapatinib |
| Brand Name | Bretolap Tablet |
| Manufacturer | Alkem Laboratories 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 15°C and 30°C (59°F to 86°F). Keep the tablets in their original container, tightly closed, and protect them from light and moisture. Do not store in the bathroom. Keep out of reach of children and pets. |
| Shelf Life | The shelf life is typically 24 months from the date of manufacture, but check the expiry date on the pack. Do not use after the expiry date. |
| WHO Guideline | Not established from the available information. Treatment should follow institutional and national oncology guidelines. |
| ICMR Guideline | Not established from the available information. Consult your oncologist for guideline-based care. |
👨⚕️ 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 reversible, small-molecule tyrosine kinase inhibitor that binds to the intracellular ATP-binding pocket of the epidermal growth factor receptor (EGFR/ErbB1) and human epidermal growth factor receptor 2 (HER2/ErbB2). By blocking the kinase activity of these receptors, it prevents autophosphorylation and downstream signaling through pathways such as MAPK and PI3K/AKT, which are important for cancer cell proliferation and survival. This leads to growth arrest and, in some cases, apoptosis of HER2-dependent cancer cells.
Mechanism Steps
💡 How to Take bretolap tablet
Strength: Immediate-release tablet containing 250 mg of lapatinib.
Dosage Information
| Adult Dosage | The usual adult dose of this medicine is 1,250 mg (five 250 mg tablets) taken once daily on days 1 to 21 continuously in combination with capecitabine, or 1,500 mg (six 250 mg tablets) once daily when used with letrozole. The dose may be reduced by your doctor if you have side effects or liver problems. Dose must be individualized by a qualified clinician based on indication, age, weight, renal and hepatic function, and other medicines you are taking. Do not change the dose without medical advice. |
| 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 side effects, especially diarrhea, dehydration, and heart problems. Close monitoring is advised. |
| Renal Impairment | No dose adjustment is needed for mild to moderate kidney impairment. There is limited information for severe kidney impairment. Use with caution and monitor closely. |
| Hepatic Impairment | For patients with moderate liver impairment (Child-Pugh class B), the dose should be reduced. For severe liver impairment (Child-Pugh class C), this medicine is contraindicated. Your doctor will decide the appropriate dose based on your liver function tests. |
| Maximum Daily Dose | The maximum recommended daily dose is 1,500 mg once daily, but this depends on the specific combination regimen and your doctor's instructions. Do not exceed the prescribed dose. |
Dosage Timeline
🍽️ Food Timing Guide
⏰ What to Do If You Miss a Dose
⚠️ Side Effects of bretolap 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 | |
| Grapefruit juice | Major | |
| Omeprazole | Moderate | |
| Amiodarone | Major | |
| Digoxin | Moderate | |
| Midazolam | Moderate | |
| St. John's wort | Major | |
| Warfarin | Moderate | |
| Phenytoin | Major |
🚨 Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice)
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort)
- Drugs that prolong QT interval (e.g., amiodarone, sotalol, some antipsychotics)
- Proton pump inhibitors (e.g., omeprazole) and H2 blockers (e.g., ranitidine)
⚡ Moderate Interactions
- CYP3A4 substrates with narrow therapeutic index (e.g., midazolam, triazolam)
- CYP2C8 substrates (e.g., repaglinide)
- P-glycoprotein substrates (e.g., digoxin)
🍷 Alcohol Interaction
Alcohol may increase the risk of liver problems and stomach upset while taking this medicine. It is best to avoid alcohol or limit it as advised by your doctor.
🔎 Check Your Other Medicines
Educational tool. Always confirm with your doctor or pharmacist.
🛡️ Safety & Warnings
🚫 Contraindications
["Known severe hypersensitivity to lapatinib or any component of the tablet.","Severe hepatic impairment (Child-Pugh class C).","Pregnancy or breastfeeding.","Use with strong CYP3A4 inhibitors or inducers should be avoided or managed with dose adjustment.","Patients with uncontrolled heart disease or recent heart attack should use with caution and only after cardiology evaluation."]
⚠️ Warnings & Precautions
["This medicine can cause severe diarrhea. Start antidiarrheal treatment early and drink plenty of fluids. Report diarrhea that does not improve or is accompanied by dizziness or weakness.","Liver injury can occur. Report yellowing of the eyes or skin, dark urine, or right upper abdominal pain immediately. Regular liver tests are required.","Heart function can decrease. Report shortness of breath, swelling of the legs, or unusual tiredness. Heart function tests are needed before and during treatment.","Severe skin reactions can occur. Report blistering, peeling, or sores in the mouth or eyes immediately.","Lung inflammation is rare but serious. Report new or worsening cough, shortness of breath, or fever.","This medicine can interact with many other medicines. Always tell your doctor about all medicines, supplements, and herbal products you are taking.","Do not take this medicine with grapefruit or grapefruit juice.","Use effective contraception during treatment and for at least one week after the last dose.","Do not breastfeed while taking this medicine.","Avoid live vaccines during treatment.","This medicine may cause tiredness or dizziness. Use caution when driving or operating machinery until you know how it affects you."]
🤱 Lactation Safety
It is not known whether this medicine passes into breast milk. Because of the potential for serious side effects in a nursing infant, breastfeeding is not recommended during treatment and for at least one week after the last dose.
💊 Overdose Management
There is no specific antidote for an overdose of this medicine. If an overdose is suspected, seek emergency medical attention immediately. Treatment should be supportive and symptomatic, with close monitoring of vital signs, liver function, heart function, and blood counts. Gastric lavage may be considered if the overdose was recent and the patient is stable. Contact a poison control center if available.
⏰ Missed Dose
If you miss a dose, take it as soon as you remember if it is more than 12 hours before your next scheduled dose. If it is less than 12 hours before your next dose, 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 only be taken under the supervision of a qualified oncologist. Do not start, stop, or change the dose without medical advice. Take the tablet at the same time each day, with or without food, but avoid taking it with grapefruit or grapefruit juice because these can increase the amount of medicine in your body. Swallow the tablet whole with water; do not crush or chew it. Because this medicine can cause diarrhea, keep oral rehydration solutions at home and report more than four loose stools in a day to your doctor. Use effective contraception during treatment and for at least one week after the last dose if you are of childbearing potential. Do not breastfeed while taking this medicine. Avoid live vaccines during treatment. Tell your doctor about all other medicines, supplements, and herbal products you are taking, especially those that affect liver enzymes or stomach acid. Regular blood tests for liver function, heart function, and blood counts are essential. If you miss a dose, do not double the next dose. If you experience severe diarrhea, yellowing of the eyes or skin, dark urine, chest pain, shortness of breath, or swelling of the legs, seek medical attention immediately.
👴 Special Considerations for Elderly
💡 For Patients Above 65
Elderly patients may be more sensitive to the side effects of this medicine, especially diarrhea, dehydration, heart problems, and liver toxicity. Close monitoring of liver and heart function is recommended. Dose adjustments may be needed based on kidney and liver function. Falls and fatigue should be managed carefully.
🤰 Pregnancy Planning (TTC)
This medicine can harm the unborn baby and is contraindicated during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least one week after the last dose. If you are planning pregnancy, discuss with your oncologist well in advance. Men with female partners of childbearing potential should also use effective contraception during treatment and for at least one week after the last dose.
🏥 Post-Surgery Considerations
If you are scheduled for surgery, inform your surgeon and anesthesiologist that you are taking this medicine. It may need to be stopped temporarily before surgery due to the risk of bleeding, infection, and heart problems. Your oncologist will advise on the timing of stopping and restarting the medicine. Wound healing may be affected, and close monitoring is needed after surgery.
🦷 Dental Procedures
Inform your dentist that you are taking this medicine before any dental procedure. Because this medicine can affect blood counts and increase infection risk, your dentist may need to take precautions. Dental work should be coordinated with your oncologist, especially if you have low white blood cell or platelet counts. Good oral hygiene is important to prevent mouth sores and infections.
💚 Lifestyle Tips for Better Results
🏋️ Exercise Considerations
Mild to moderate exercise such as walking or yoga may help with fatigue and overall well-being, but you should avoid strenuous activity if you have diarrhea, dizziness, or heart symptoms. Always consult your doctor before starting any exercise program while on this medicine.
🥗 Diet Recommendations
💼 Impact on Daily Work & Life
This medicine may cause tiredness, dizziness, or diarrhea, which can affect your ability to work or drive. You should avoid driving or operating heavy machinery until you know how this medicine affects you. Most patients can continue with light work and daily activities, but you may need to take time off during severe side effects or hospital visits. Discuss your work schedule with your doctor and employer to make necessary adjustments.
🛑 When to Stop This Medicine
Do not stop taking this medicine without consulting your oncologist. Your doctor may decide to stop treatment if the cancer progresses, if you develop serious side effects such as severe liver injury or heart failure, or if you cannot tolerate the medicine. If you experience any red-flag symptoms, contact your doctor immediately; they will advise whether to continue, reduce the dose, or stop the medicine.
📅 Long-Term Use Effects
Long-term use of this medicine may lead to persistent diarrhea, skin changes, and fatigue. Regular monitoring of liver and heart function is essential because toxicity can develop over time. Some patients may experience chronic hand-foot syndrome or nail changes. The risk of heart failure and liver injury continues with prolonged use, so periodic testing is necessary. Your doctor will weigh the benefits of continued treatment against the risks and may adjust or stop the medicine if serious side effects occur.
🌿 Non-Medicine Approaches
These can complement medicine but do not replace prescribed treatment.
Another HER2-targeted treatment that may be used instead of or in combination with this medicine.
Evidence: Well-establishedA combination regimen for HER2-positive breast cancer.
Evidence: Well-establishedParticipation in clinical trials of new HER2-targeted therapies may be an option.
Evidence: VariesPain management, nutritional support, and psychological support can complement cancer treatment.
Evidence: Well-established💉 Vaccination Considerations
💉 If You're Getting Vaccinated
Live vaccines should be avoided while taking this medicine because the immune system may be suppressed. Inactivated vaccines are generally safe, but consult your doctor before receiving any vaccine. Timing of vaccines 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 container, tightly closed.
❌ DON'T
Do not transfer to unmarked containers.
✅ DO
Protect from light and moisture.
❌ 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 traveling, carry this medicine in its original packaging with the prescription label clearly visible. Bring a copy of your prescription and a letter from your doctor explaining that you are taking this medicine for cancer treatment. Keep the tablets in your carry-on luggage to avoid loss or temperature extremes. Store at room temperature and protect from light and moisture. If crossing time zones, continue taking your dose at the same interval as prescribed; discuss any adjustments with your oncologist. Check customs regulations for controlled or prescription medicines in your destination country. Carry enough supply for the 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: This medicine starts working at the cellular level soon after you take it, but its full anticancer effect builds over weeks to months. Your doctor will assess response with regular scans and tests.
A: Yes, you can take it with or without food, but it is best to take it the same way each day. Avoid grapefruit and grapefruit juice.
A: If you remember within 12 hours of the missed dose, take it as soon as you remember. If more than 12 hours have passed, skip the missed dose and continue with your regular schedule. Do not double the dose.
A: This medicine is a targeted therapy and does not usually cause hair loss. Hair loss is more common with traditional chemotherapy.
A: No, you should not stop taking this medicine without talking to your oncologist. Stopping early may allow the cancer to grow.
A: Yes, it can decrease heart pumping function in some patients. Your doctor will check your heart function before and during treatment.
A: No, this medicine can harm the unborn baby. Use effective contraception during treatment and for at least one week after the last dose.
A: Avoid grapefruit and grapefruit juice, St. John's wort, and live vaccines. Tell your doctor about all other medicines and supplements you take.
🤔 Common Patient Concerns
🔄 Substitutes for bretolap tablet
View AllAlternative brands with exact same active ingredient:
-
libset tabletIntas Pharmaceuticals Ltd ₹5,995.00 0.1% COSTLIER
-
herduo tabletNatco Pharma Ltd ₹6,000.00 0.2% COSTLIER
-
herlapsa tabletMylan Pharmaceuticals Pvt Ltd ₹8,057.00 34.5% COSTLIER
-
du knib 250mg tabletSayre Therapeutics Pvt Ltd ₹8,100.00 35.2% COSTLIER
-
lanib 250 tabletBDR Pharmaceuticals Internationals Pvt ₹8,100.00 35.2% COSTLIER
Medical Note: Always consult your doctor before switching medications.
🛑 Myths vs. Facts
- Myth: This medicine is a traditional chemotherapy that causes hair loss.
Fact: This medicine is a targeted therapy and does not usually cause hair loss. It works differently from traditional chemotherapy. - Myth: This medicine can be taken without regular blood tests.
Fact: Regular blood tests for liver function, heart function, and blood counts are essential because this medicine can cause serious side effects. - Myth: This medicine can be taken with grapefruit juice.
Fact: Grapefruit and grapefruit juice should be avoided because they can increase the levels of this medicine and cause more side effects. - Myth: This medicine can be stopped when you feel better.
Fact: This medicine should only be stopped on the advice of your oncologist. Stopping early may allow the cancer to grow.
🔄 Alternative Options
Generic Alternatives
- Lapatinib 250 mg tablet
Brand Alternatives
- Bretolap tablet