w.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A Inducers: Contraindicated with strong CYP3A inducers. Avoid concomitant use with moderate CYP3A inducers. (2.3, 7.1)
CYP3A Inhibitors: Avoid concomitant use with strong CYP3A inhibitors; reduce LORBRENA dose if concomitant use cannot be avoided. (2.4, 7.1)
CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious therapeutic failures. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
LORBRENA® is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on
crizotinib and at least one other ALK inhibitor for metastatic disease; or
alectinib as the first ALK inhibitor therapy for metastatic disease; orceritinib as the first ALK inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on tumor response rate and duration of response [see CLINICAL STUDIES (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage of LORBRENA is 100 mg orally once daily, with or without food, until disease progression or unacceptable toxicity [see CLINICAL PHARMACOLOGY (12.3)].
Swallow tablets whole. Do not chew, crush or split tablets. Do not ingest if tablets are broken, cracked, or otherwise not intact.
Take LORBRENA at the same time each day. If a dose is missed, then take the missed dose unless the next dose is due within 4 hours. Do not take 2 doses at the same time to make up for a missed dose.
Do not take an additional dose if vomiting occurs after LORBRENA but continue with the next scheduled dose.
2.2 Dosage Modifications for Adverse Reactions
The recommended dose reductions are:
First dose reduction: LORBRENA 75 mg orally once daily
Second dose reduction: LORBRENA 50 mg orally once daily
Permanently discontinue LORBRENA in patients who are unable to tolerate 50 mg orally once daily.
Dosage modifications for adverse reactions of LORBRENA are provided in Table 1.
Table 1 Recommended LORBRENA Dosage Modifications for Adverse Reactions
Abbreviation: AV=atrioventricular.
* Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
2.3 Concomitant Use of Strong or Moderate CYP3A Inducers
LORBRENA is contraindicated in patients taking strong CYP3A inducers. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. Avoid concomitant use of LORBRENA with moderate CYP3A inducers [see WARNINGS AND PRECAUTIONS (5.1), CLINICAL PHARMACOLOGY (12.3)].
2.4 Dosage Modification for Strong CYP3A Inhibitors
Avoid concomitant use of LORBRENA with strong CYP3A inhibitors. If concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the starting dose of LORBRENA from 100 mg orally once daily to 75 mg orally once daily.
In patients who have had a dose reduction to 75 mg orally once daily due to adverse reactions and who initiate a strong CYP3A inhibitor, redu |
