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Unmet Need Molecular Structure Guidelines Study design Efficacy Safety Dosing and Therapy Management Summary Important Safety Information Abbreviated Prescribing Information
Important Safety Information

Indications: LORBRENA™ is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.1

Dosage and administration: The recommended dosage of LORBRENA is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Warnings and precautions:
  • Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer.
  • Central Nervous System Effects
    A broad spectrum of central nervous system (CNS) effects can occur in patients receiving LORBRENA. These include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume at the same dose or at a reduced dose or permanently discontinue LORBRENA based on severity.
  • Initiate or increase the dose of lipid-lowering agents in patients with hyperlipidemia. Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter. Withhold and resume at the same dose for the first occurrence; resume at the same or a reduced dose of LORBRENA for recurrence based on severity.1

Adverse reactions: 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.1

References:Lorbrena™ EDA leaflet approval date 26/4/2021.

MOH Approval No: HF0098OA54/062022
Invalidation date: 12/06/2024

Adverse events should be reported. Adverse events can be reported to [email protected]

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