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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg or 100 mg. (3)
Concomitant use with strong CYP3A inducers. (4)
WARNINGS AND PRECAUTIONS
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. (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.
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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