Lorbrexen 100 mg (Generic Lorlatinib) – Everest Pharmaceuticals

Lorbrexen 100 mg is a generic formulation of Lorlatinib — a third-generation, macrocyclic ALK and ROS1 inhibitor — manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP certified conditions in Bangladesh. Each tablet contains 100 mg of lorlatinib, the same active molecule found in Lorbrena® (Pfizer), and is dispensed under the Named Patient Program for patients who require an affordable alternative after progression on earlier-generation ALK inhibitors.

Lorlatinib’s defining characteristic is its activity against virtually all known ALK resistance mutations and the most potent CNS penetration of any ALK inhibitor available.

Lorlatinib is a macrocyclic kinase inhibitor engineered specifically to overcome the resistance mutations that develop during first- and second-generation ALK inhibitor therapy. It retains activity against the most clinically relevant resistance mutations — including those that defeat alectinib and brigatinib.

Lorlatinib has a distinct side-effect profile from earlier ALK inhibitors — particularly its effects on lipid levels and, in some patients, the central nervous system.

• Week 1–2: Hypercholesterolaemia (elevated cholesterol and triglycerides) occurs in the majority of patients and often begins within the first two weeks. Oedema (swelling of ankles and legs) is also common.
• Weeks 2–3: Some patients notice cognitive or mood changes — mild difficulty with word-finding, short-term memory, or concentration. These CNS effects should be reported honestly to your oncologist, not concealed.
• Week 4: Most patients see early clinical benefit. Brain metastasis responses can be dramatic. Your oncologist will schedule a scan and blood tests for lipids, glucose, and liver function.

Lorlatinib’s side-effect profile includes some effects unique to this drug. Open communication with your care team about all symptoms — including cognitive ones — is essential.

Standard dose: 100 mg once daily, with or without food. Your oncologist will confirm if a lower starting dose is appropriate.

• 1
  Once daily at the same time — consistency of timing maintains stable blood levels.
• 2
  Swallow tablet whole with a full glass of water. Do not crush, split, or chew.
• 3
  Avoid strong CYP3A4 inducers — rifampicin, carbamazepine, St John’s Wort, and phenytoin significantly reduce lorlatinib blood levels. Inform your doctor of all medications.
• 4
  Lipid-lowering therapy may be started by your oncologist alongside lorlatinib. Take any prescribed statins as directed — do not discontinue without advice.
• 5
  Storage: below 25°C, protected from moisture, light, and out of reach of children.

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  Watch for cognitive and mood changes — caregivers often notice these changes before the patient does. Keep a symptom diary and share it honestly with the care team.
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  Monitor oedema — check ankle and leg swelling daily. If swelling increases rapidly or involves the face or hands, contact the oncologist the same day.
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  Ensure diet and lipid monitoring — lorlatinib raises cholesterol significantly. Support a heart-healthy, low-saturated-fat diet and ensure scheduled lipid blood tests are not missed.