Lorlatinib/Lorlatinib Instructions

1. Generic name: Lorlatinib

Product name:Lorbrena

All names:lorlatinib,lorlatinib, Lorlatinib, Lorbrena

2. Indications

Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are positive for anaplastic lymphoma kinase (ALK) by an FDA-approved test.

Three. Dosage and usage

Recommended dose: 100mg orally, once daily.

Severe renal impairment: 75mg orally, once daily.

Four. Dosage form and strength

Tablets: 25mg or 100mg.

Five. Contraindications

Concurrent use with strongCYP3A inducers.

6. Warnings and Precautions

Risk of serious hepatotoxicity concomitant use of strongCYP3A inducers:Discontinue strongCYP3A inducers3 plasma half-lives before initiatinglorlatinib.

Central Nervous System(CNS)Effects: CNSEffects include seizures, psychotic effects, and cognitive function, mood(Including suicidal ideation) Changes in speech, mental status, and sleep. Depending on severity, withhold or resume lorlatinib at the same or reduced dose, or permanently discontinue lorlatinib.

Hyperlipidemia:Initiate or increase the dose of lipid-lowering drugs. Withhold or resume the same or reduced dose of lorlatinib based on severity.

AV block:Keep and resume the same or reduced doselorlatinib based on severity.

Interstitial Lung Disease/Pneumonitis:Discontinue lorlatinib immediately in patients with suspectedILD/pneumonitis. Permanently discontinuelorlatinib for treatment-relatedILD/pneumonitis of any severity.

Hypertension: Monitor blood pressure after 2 weeks and at least once a month during treatment. For severe hypertension, discontinue lorlatinib and then reduce the dose or permanently discontinue lorlatinib. (2.3, 5.6)

Hyperglycemia:Assess fasting blood glucose before initiatinglorlatinib and periodically during treatment. If adequate control is not achieved with optimal medical management, discontinue lorlatinib and consider dose reduction or permanent discontinuation based on severity.

Embryo-Fetal Toxicity:Can cause fetal harm. Inform women of reproductive potential about the potential risk to the fetus and recommend that men and women of childbearing potential use effective non-hormonal contraceptive methods.

7. Adverse reactions

The most common (incidence≥20%)adverse reactions and grade 3-4 laboratory abnormalities are edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough.

8. Drug interactions

StrongCYP3AInducers:Contraindicated.

ModerateCYP3AInducers:Avoid coadministration. If coadministration cannot be avoided, increase the dose of lorlatinib.

PowerfulCYP3AInhibitors:Avoid combined use; if combined use cannot be avoided, reduce the dose of lorlatinib.

Fluconazole: Avoid concomitant use; if concomitant use cannot be avoided, reduce the dose of lorlatinib .

CertainCYP3Asubstrates:Avoid coadministration with CYP3Asubstrates as minimal concentration changes may result in serious treatment failure.

CertainP-gpsubstrates:Avoid concurrent use with P-gpsubstrates as minimal concentration changes may result in serious treatment failure.

8. Use among specific groups of people

Lactation:It is recommended not to breastfeed.

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