LORBRENA- lorlatinib tablet, film coated
Pfizer Laboratories Div Pfizer Inc
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LORBRENA safely and effectively. See full prescribing information for LORBRENA.
LORBRENA®(lorlatinib)tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on
crizotinib and at least one other ALK inhibitor for metastatic disease; or
alectinib as the first ALK inhibitor therapy for metastatic disease; or
ceritinib as the first ALK inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg or 100 mg. (3)
CONTRAINDICATIONS
Concomitant use with strong CYP3A inducers. (4)
WARNINGS AND PRECAUTIONS
Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. (2.3, 5.1)
Central Nervous System (CNS) Effects: CNS effects include seizures, hallucinations and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume LORBRENA at same or reduced dose or permanently discontinue LORBRENA based on severity. (2.2, 5.2)
Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.3)
Atrioventricular Block: Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.4)
Interstitial Lung Disease/Pneumonitis: Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity. (2.2, 5.5)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective non-hormonal method of contraception. (5.6, 7.2, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) are edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inducers: Contraindicated with strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers. (2.3, 7.1)
CYP3A Inhibitors: Avoid concomitant use with strong CYP3A inhibitors; reduce LORBRENA dose if concomitant use cannot be avoided. (2.4, 7.1)
CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious therapeutic failures. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient |
