s permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers
Inform patients of the potential risk of hepatoxicity with the concomitant use of strong CYP3A inducers.
Advise patients to inform their healthcare providers of all medications they are taking, including prescription medicines, over-the-counter drugs, vitamins, and herbal products (e.g., St. John's wort) [see Warnings and Precautions (5.1)].
Central Nervous System (CNS) Effects
Advise patients to notify their healthcare provider if they experience new or worsening CNS symptoms [see Warnings and Precautions (5.2)].
Hyperlipidemia
Inform patients that serum cholesterol and triglycerides will be monitored during treatment. Advise patients that initiation or an increase in the dose of lipid-lowering agents may be required [see Warnings and Precautions (5.3)].
Atrioventricular (AV) Block
Inform patients of the risks of AV block. Advise patients to contact their healthcare provider immediately to report new or worsening cardiac symptoms [see Warnings and Precautions (5.4)].
Interstitial Lung Disease (ILD)/Pneumonitis
Inform patients of the risks of severe ILD/pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.5)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective non-hormonal contraception during treatment with LORBRENA and for at least 6 months after the final dose [see Use in Specific Populations (8.3)].
Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LORBRENA and for at least 3 months after the final dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Lactation
Advise women not to breastfeed during treatment with LORBRENA and for 7 days after the final dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that LORBRENA may transiently impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
This product's label may have been updated. For full prescribing information, please visit www.LORBRENA.com.
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LAB-1162-1.0
PATIENT INFORMATION
LORBRENA (lor-BREN-ah)
(lorlatinib)
tablets
This Patient Information has been approved by the U.S. Food and Drug Administration. November 2018
What is the most important information I should know about LORBRENA?
LORBRENA may cause serious side effects, including:
Liver problems due to interactions with other medicines. It is important to know what medicines should not be taken with LORBRENA.
Problems with brain (central nervous system [CNS]) function. Many patients experienced problems with brain function including problems with thinking (such as forgetfulness or confusion), mood (such as depression), speech, seeing or hearing things that are not real (hallucinations), a |
