Source: FDA, National Drug Code (US) Revision Year: 2021
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
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.
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.
The recommended dose reductions are:
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:
| Adverse Reaction* | Dosage Modifications |
|---|---|
| Central Nervous System Effects [see Warnings and Precautions (5.2)] | |
| Grade 1 | Continue at the same dose or withhold the dose until recovery to baseline. Resume LORBRENA at the same dose or at a reduced dose. |
| Grade 2 OR Grade 3 | Withhold dose until Grade 0 or 1. Resume LORBRENA at a reduced dose. |
| Grade 4 | Permanently discontinue LORBRENA. |
| Hyperlipidemia [see Warnings and Precautions (5.3)] | |
| Grade 4 hypercholesterolemia OR Grade 4 hypertriglyceridemia | Withhold LORBRENA until recovery of hypercholesterolemia and/or hypertriglyceridemia to less than or equal to Grade 2. Resume LORBRENA at the same dose. If severe hypercholesterolemia and/or hypertriglyceridemia recurs, resume LORBRENA at a reduced dose. |
| Atrioventricular (AV) Block [see Warnings and Precautions (5.4)] | |
| Second-degree AV block | Withhold LORBRENA until PR interval is less than 200 ms. Resume LORBRENA at a reduced dose. |
| First occurrence of complete AV block | Withhold LORBRENA until• pacemaker placed OR • PR interval less than 200 ms. If a pacemaker is placed, resume LORBRENA at the same dose. If no pacemaker is placed, resume LORBRENA at a reduced dose. |
| Recurrent complete AV block | Place pacemaker or permanently discontinue LORBRENA. |
| Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.5)] | |
| Any Grade treatment–related ILD/Pneumonitis | Permanently discontinue LORBRENA. |
| Other Adverse Reactions | |
| Grade 1 OR Grade 2 | Continue LORBRENA at same dose or reduced dose. |
| Grade 3 OR Grade 4 | Withhold LORBRENA until symptoms resolve to less than or equal to Grade 2 or baseline. Resume LORBRENA at reduced dose. |
Abbreviation: AV=atrioventricular.
* Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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 [see Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Avoid concomitant use of moderate CYP3A inducers with LORBRENA. If concomitant use with moderate CYP3A inducers is unavoidable, increase the LORBRENA dose to 125 mg once daily [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Avoid concomitant use of LORBRENA with strong CYP3A inhibitors. If concomitant use with a strong CYP3A inhibitor is unavoidable, 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, reduce the LORBRENA dose to 50 mg orally once daily.
If concomitant use of a strong CYP3A inhibitor is discontinued, increase the LORBRENA dose (after 3 plasma half-lives of the strong CYP3A inhibitor) to the dose that was used before starting the strong inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
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