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LORBRENA®Dosage and Administration (lorlatinib)

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
Adverse Reaction*Dosage Modifications
Abbreviation: AV=atrioventricular.
*
Grade based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Central Nervous System Effects [see Warnings and Precautions (5.2)]
Grade 1Continue 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 3Withhold dose until Grade 0 or 1. Resume LORBRENA at a reduced dose.
Grade 4Permanently 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 blockWithhold LORBRENA until PR interval is less than 200 ms. Resume LORBRENA at a reduced dose.
First occurrence of complete AV blockWithhold 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 blockPlace pacemaker or permanently discontinue LORBRENA.
Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.5)]
Any Grade treatment–related ILD/PneumonitisPermanently discontinue LORBRENA.
Other Adverse Reactions
Grade 1 OR Grade 2Continue LORBRENA at same dose or reduced dose.
Grade 3 OR Grade 4Withhold LORBRENA until symptoms resolve to less than or equal to Grade 2 or baseline. Resume LORBRENA at reduced dose.

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, 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 Clinical Pharmacology (12.3)].

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