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LORBRENA®(lorlatinib)
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LORBRENA® Quick Finder
1 INDICATIONS AND USAGE
LORBRENA® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose...
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for the treatment of metastatic NSCLC with...
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...
4 CONTRAINDICATIONS
LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity [see Warnings and Precautions (5.1)]...
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers
...
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...
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on LORBRENA
Strong CYP3A Inducers
...8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
11 DESCRIPTION
LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C21H19FN6O2 (...
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...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with lorlatinib. Lorlatinib was...
14 CLINICAL STUDIES
Previously Untreated ALK-Positive Metastatic NSCLC (CROWN Study)
The efficacy of LORBRENA for the treatment of...
16 HOW SUPPLIED/STORAGE AND HANDLING
Table 11 describes the available strengths and package configurations for LORBRENA:
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Risk of...
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 either 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.
(800)-332-1088.