HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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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.
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of metastatic NSCLC with...
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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 × 17 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
...
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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 from...
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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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Report Adverse Event
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.
If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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 https://vaers.hhs.gov or call (800) 822-7967.