Product Information
Lorbrexen (Lorlatinib) 100mg is a potent, brain-penetrant, third-generation ALK and ROS1 tyrosine kinase inhibitor used to treat ALK-positive metastatic Non-Small Cell Lung Cancer (NSCLC), both as first-line therapy and in patients whose disease has progressed after earlier ALK inhibitor treatment. It works by inhibiting the ALK fusion protein with broad coverage of ALK resistance mutations, and was specifically designed to achieve strong penetration into the central nervous system, making it particularly useful for patients with brain metastases. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Lorbrexen (Lorlatinib) 100mg
| Brand Name | Lorbrexen (Lorlatinib) |
| Generic Name | Lorlatinib INN |
| Drug Class | Third-Generation ALK and ROS1 Tyrosine Kinase Inhibitor |
| Available Strength | 100mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 1 Bottle of 30 Tablets per Box |
| Primary Indication | ALK-Positive Metastatic NSCLC (First-Line and After Prior ALK Inhibitor Therapy) |
| Regulatory Approvals | USFDA Approved (First-Line and Later-Line ALK-Positive NSCLC). Carries an FDA Boxed Warning for CNS effects and hepatotoxicity risk with strong CYP3A inducers. |
| Originator Brand | Lorbrena (Lorviqua in the EU) by Pfizer |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration | Registered in Bangladesh |
| Storage Conditions | Store below 30 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children. |
How Lorbrexen (Lorlatinib) Works
Lorbrexen contains Lorlatinib, a third-generation kinase inhibitor with potent activity against the ALK (anaplastic lymphoma kinase) fusion protein and ROS1. Lorlatinib was engineered with broad coverage of the resistance mutations that commonly emerge after treatment with earlier-generation ALK inhibitors, giving it activity in tumours that have already stopped responding to other ALK-targeted therapies.
A defining feature of Lorlatinib is its strong ability to cross the blood-brain barrier, achieving meaningful drug concentrations within the central nervous system. In early clinical studies, Lorlatinib showed activity in patients with ALK-positive NSCLC, most of whom had brain metastases and had already progressed on prior ALK-directed therapy, an area of significant unmet need in lung cancer treatment. This CNS penetration is also linked to the characteristic CNS side-effect profile described below.
Lorbrexen is taken as a once-daily oral tablet, and treatment is only appropriate for patients whose tumours have been confirmed to be ALK-positive, using an approved diagnostic test.
Indications for Lorbrexen (Lorlatinib)
Lorbrexen (Lorlatinib) is indicated for the following conditions:
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First-Line ALK-Positive Metastatic NSCLC For adult patients with metastatic NSCLC whose tumours are ALK-positive, as detected by an approved test, as initial treatment. |
ALK-Positive NSCLC After Prior ALK Inhibitor Therapy For patients whose disease has progressed on alectinib or ceritinib as their first ALK inhibitor for metastatic disease, or on crizotinib and at least one other ALK inhibitor. |
Benefits of Lorbrexen (Lorlatinib) 100mg
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Strong Central Nervous System Activity Lorbrexen’s high blood-brain barrier penetration makes it particularly valuable for ALK-positive NSCLC patients with brain metastases, a common and difficult-to-treat complication. |
Effective After Earlier ALK Inhibitors Lorbrexen’s broad coverage of ALK resistance mutations gives it activity in tumours that have already progressed on earlier-generation ALK-targeted therapies. |
Backed by the CROWN Trial Lorbrexen’s first-line approval is supported by the Phase 3 CROWN trial, a major clinical study establishing its efficacy as initial therapy for ALK-positive NSCLC. |
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Affordable Alternative to Lorbrena Lorbrexen contains the same active ingredient as Lorbrena by Pfizer, at a significantly lower cost, making this precision therapy more financially accessible. |
Convenient Once-Daily Dosing Lorbrexen is taken as a single oral tablet once daily, with or without food, offering a manageable outpatient regimen. |
cGMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under cGMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Lorbrexen tablets. |
How to Take Lorbrexen (Lorlatinib)
Route: Oral, with or without food. Tablets should be swallowed whole; do not chew, crush, or split tablets, and do not take any tablet that is broken, cracked, or otherwise not intact.
Standard dose: 100mg (one tablet) taken orally once daily, continued until disease progression or unacceptable toxicity, exactly as directed by the prescribing oncologist.
Missed dose: If a dose is missed, take it as soon as remembered on the same day, unless the next dose is due within 4 hours, in which case skip the missed dose and resume the normal schedule.
Dose reduction for toxicity: Dose interruption and/or reduction in defined steps may be required to manage CNS effects, hyperlipidaemia, or other adverse reactions, as directed by the prescribing physician.
Severe hepatic impairment: The recommended dose is reduced to 50mg once daily.
Renal impairment: The recommended dose is reduced to 75mg once daily, as directed by the prescribing physician.
Paediatric use: The safety and efficacy of Lorbrexen in paediatric patients have not been established. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Lorbrexen treatment. Your oncologist will monitor closely for new or worsening CNS symptoms, including changes in thinking, mood, speech, sleep, or behaviour, particularly during the early months of treatment. Monitoring also includes periodic lipid panels, as Lorbrexen very commonly raises cholesterol and triglyceride levels and may require lipid-lowering therapy, along with periodic liver function tests and weight and cardiac monitoring. Report any confusion, memory problems, mood changes, thoughts of self-harm, difficulty speaking, sleep disturbances, seizures, or unusual behaviour to your oncology team and family immediately, as these can develop gradually and may not always be recognised by the patient themselves.
Drug Interactions and Important Information
Lorbrexen is contraindicated with strong CYP3A inducers (such as rifampin, carbamazepine, phenytoin, and St. John’s Wort), due to a risk of serious hepatotoxicity; these must be discontinued for at least 3 half-lives before starting Lorbrexen. Use caution with strong CYP3A inhibitors, which may increase Lorlatinib exposure. Use caution when combining Lorbrexen with other medicines affecting the central nervous system, or with alcohol.
Lorbrexen can make hormonal contraceptives ineffective; women of childbearing potential must use an effective, non-hormonal method of contraception during treatment and for at least 6 months after the final dose. Men with partners of childbearing potential should use effective contraception during treatment and for 3 months after the final dose. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Lorbrexen.
Side Effects and Precautions
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Common Side Effects Elevated cholesterol and triglycerides (hyperlipidaemia) Fatigue and weight gain Oedema (swelling) and constipation Peripheral neuropathy (numbness/tingling) Nausea, vomiting, and diarrhoea Headache, dizziness, and difficulty sleeping Muscle/joint pain and vision changes |
Serious Warnings and Precautions CNS effects, including seizures, psychosis, cognitive changes, and mood changes including suicidal ideation. See boxed warning. Serious hepatotoxicity with strong CYP3A inducers. See boxed warning. Severe hyperlipidaemia, requiring monitoring and often lipid-lowering therapy. Atrioventricular block and cardiac conduction effects. Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Lorbrexen (Lorlatinib)?
Lorbrexen is suitable for adult patients with ALK-positive metastatic NSCLC, confirmed by an approved biomarker test, either as first-line therapy or after progression on prior ALK-directed treatment. It is prescribed by medical oncologists and thoracic oncology specialists experienced in biomarker-guided cancer therapy and in monitoring for CNS adverse effects. A thorough medical assessment including ALK testing, baseline lipid panel, liver function, and a review of concomitant medications for CYP3A interactions is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, focused on complex, technology-driven specialty medicines across oncology, nephrology, and virology. Operating under Bangladesh’s TRIPS/Doha Declaration exemption for least-developed countries, Everest manufactures advanced generics such as Lorbrexen under cGMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Lorbrexen is one of Everest’s specialty oncology products, offering a bioequivalent alternative to Lorbrena by Pfizer at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty and oncology medications. We ensure Lorbrexen (Lorlatinib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Lorbrexen (Lorlatinib) from Mediaid Pharmacy?
Lorbrexen represents one of the most advanced options available for ALK-positive lung cancer, with particular strength against brain metastases and resistant disease. As the generic equivalent of Lorbrena by Pfizer, it delivers the same active ingredient, Lorlatinib, with the same proven, brain-penetrant ALK-inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under cGMP-compliant standards and distributed globally by Mediaid Pharmacy, Lorbrexen gives patients worldwide access to advanced targeted lung cancer therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Lorlatinib option with worldwide delivery, Lorbrexen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Lorbrexen (Lorlatinib)
What is Lorbrexen (Lorlatinib) used for?
Lorbrexen (Lorlatinib) is used to treat adult patients with ALK-positive metastatic NSCLC, either as first-line treatment or after the disease has progressed on prior ALK inhibitor therapy such as crizotinib, alectinib, or ceritinib. It works by blocking the ALK protein that drives these cancers and penetrates well into the brain, helping treat associated brain metastases.
How should I take Lorbrexen (Lorlatinib)?
Lorbrexen is taken orally, once daily, with or without food. The standard dose is 100mg (one tablet) once daily. Tablets should be swallowed whole and never split, crushed, or chewed. Always follow your oncologist’s exact instructions.
What strength is Lorbrexen available in?
Lorbrexen is available in a 100mg film-coated tablet, supplied as a bottle of 30 tablets in each box, providing a full 30-day supply at the standard once-daily dose.
Is Lorbrexen the same as Lorbrena (Lorlatinib by Pfizer)?
Yes. Lorbrexen is the generic equivalent of Lorbrena (marketed as Lorviqua in some regions). Both contain the same active ingredient, Lorlatinib, and work through the same ALK-inhibition mechanism. Lorbrexen is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offers the same clinical mechanism as Lorbrena at a significantly lower cost.
What are the side effects of Lorbrexen (Lorlatinib)?
Very common side effects include elevated cholesterol and triglycerides, fatigue, weight gain, swelling, and numbness or tingling. Lorbrexen also carries a boxed warning for CNS effects, including changes in mood, thinking, speech, and sleep, which occurred in over half of patients in clinical trials. Always consult your oncology team for a complete assessment of your individual risks and benefits before starting treatment.
Can Lorbrexen be used with other medications?
Lorbrexen must not be combined with strong CYP3A inducers, which must be stopped for at least 3 half-lives before starting treatment, due to a serious liver injury risk. Lorbrexen can also make hormonal contraceptives ineffective, so non-hormonal contraception is required. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Lorbrexen.
Is Lorbrexen (Lorlatinib) safe during pregnancy or breastfeeding?
No. Lorbrexen is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Women of childbearing potential must use effective, non-hormonal contraception during treatment and for at least 6 months after the final dose, and men should use contraception for at least 3 months after their final dose. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Lorbrexen (Lorlatinib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Lorbrexen (Lorlatinib) 100mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Lorbrexen (Lorlatinib) 100mg with Worldwide Shipping
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