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LORBRENA® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

2.1 Patient Selection

Select patients for the treatment of metastatic NSCLC with...

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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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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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5 WARNINGS AND PRECAUTIONS

5.1 Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers

...

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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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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on LORBRENA

Strong CYP3A Inducers

...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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11 DESCRIPTION

LORBRENA (lorlatinib) is a kinase inhibitor for oral administration. The molecular formula is C21H19FN6O2 (...

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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with lorlatinib. Lorlatinib was...

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14 CLINICAL STUDIES

Previously Untreated ALK-Positive Metastatic NSCLC (CROWN Study)

The efficacy of LORBRENA for the treatment of...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Table 11 describes the available strengths and package configurations for LORBRENA:

...
Table 11 LORBRENA Tablets
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.LORBRENA.com.

...

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