HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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LORBRENA® (lorlatinib)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
LORBRENA® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of metastatic NSCLC with LORBRENA based on the...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Tablets:
- •
- 25 mg: 8 mm round, tan, immediate release, film-coated, debossed with "Pfizer" on one side and "25" and "LLN" on the other side
- •
- 100 mg: 8.5 mm ×...
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Contraindications
4 CONTRAINDICATIONS
LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity [see Warnings and Precautions (5.1)]...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers
Severe hepatotoxicity occurred in 10 of 12 healthy...
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Adverse Reactions
6 ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- •
- Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on LORBRENA
Strong CYP3A Inducers
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings...
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Description
11 DESCRIPTION
LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C21H19FN6O2 (...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Lorlatinib is a kinase inhibitor with in vitro activity against ALK and ROS1 as well as TYK1, FER, FPS, TRKA, TRKB...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with lorlatinib. Lorlatinib was...
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Clinical Studies
14 CLINICAL STUDIES
Previously Untreated ALK-Positive Metastatic NSCLC (CROWN Study)
The efficacy of LORBRENA for the treatment of...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Table 11 describes the available strengths and package configurations for LORBRENA:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of...
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Other
This product's labeling may have been updated. For the most recent prescribing information, please visit www.Pfizer.com. For medical...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.