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Unmet Need Molecular Structure Guidelines Study design Efficacy Safety Dosing and Therapy Management Summary Important Safety Information Abbreviated Prescribing Information
Dosing and Therapy Management

Dosing Schedule

Dose modification

LORBRENA™ has a once-daily dosing schedule1

Dosing recommendations1

The recommended dose for LORBRENA™ is 100 mg taken orally once daily, with or without food.
If a dose reduction is needed, LORBRENA™ is also available as a 25 mg tablet.
Not actual size of tablets

Dosing guidance1

LORBRENA™ tablets should be swallowed whole.
The tablets should not be chewed, crushed or split prior to swallowing.
LORBRENA™ is contraindicated in patients taking strong CYP3A inducers.*
While taking LORBRENA™, consider alternative medicinal products to strong CYP3A inhibitors with less potential to inhibit CYP3A.*

*Please refer to the full LORBRENA LPD for recommendations regarding the use of CYP3A4/5 inducers and CYP3A4/5 inhibitors.1

LORBRENA™ is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.1

Abbreviations: CYP, Cytochrome; LPD, Local Product Document.

References:Lorbrena™ EDA leaflet approval date 26/4/2021.
Dose modifications may enable patients to remain on treatment1
  • Dose modifications* can be used to manage adverse reactions associated with LORBRENA™1†

LORBRENA™ dose modifications: Hyperlipidemia1

Hyperlipidemia was generally managed with lipid-lowering agents and dose interruptions, with or without dose modifications.2

Patients should have their serum cholesterol and triglycerides monitored:1

  • Before initiation of LORBRENA™
  • 1 and 2 months after initiating LORBRENA™ 
  • Periodically thereafter

LORBRENA™ dose modifications: CNS adverse reactions1

Advise patients to notify their healthcare provider if they experience new or worsening CNS symptoms.1

In some cases, LORBRENA™ needs to be withheld and then the dose reduced.
For Grade 4 adverse reactions, permanently discontinue LORBRENA™.1


CNS adverse reactions experienced with LORBRENA™ include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep.1

LORBRENA™ dose modifications: ILD/pneumonitis1

Severe or life-threatening pulmonary adverse reactions consistent with ILD/pneumonitis have occurred with LORBRENA™.1

Any Grade treatment–related ILD/Pneumonitis, permanently discontinue LORBRENATM1

Any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis should be promptly evaluated. Symptoms include:1

  • Dyspnea 
  • Cough
  • Fever

Immediately withhold LORBRENATM in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENATM for treatment-related ILD/pneumonitis of any severity.

LORBRENA™ dose modifications: AV block1

PR interval prolongation and AV block have been reported in patients receiving LORBRENA™.1
  • AV block occurred in 1.9% experienced AV block and 0.2% experienced Grade 3 AV block and underwent pacemaker placement1 § 

The recommendations for dose modifications vary according to the degree of AV block.1

Recommendations for monitoring patients:1
  • Monitor ECG prior to initiating LORBRENA™ and monthly thereafter, particularly in patients with predisposing conditions to clinically significant cardiac events

LORBRENA™ dose modifications: Other adverse reactions1

Grades 1 and 2 adverse reactions:1
  • Consider no dose modification or reduce by one dose level, as clinically indicated

Grade ≥3 adverse reactions:1
  • Withhold LORBRENA™ until symptoms resolve to ≤ Grade 2 or baseline,and then resume LORBRENA™ at one reduced dose level

Please refer to the LORBRENA™ Local Product Document, Therapy Management package (available from your representative) or medical information for dose recommendations for different grades of adverse reactions. 

*Dose interruptions associated with TRAEs were reported in 83 patients (30%). Dose reductions due to TRAEs were reported in 61 patients (22%).3
ing adverse events: hyperlipidemia, CNS effects, increased lipase/amylase, ILD/pneumonitis, AV block. Please refer to the LORBRENA™ Local Product Document, Therapy Management package (available from your representative), or medical information for dose recommendations for these adverse reactions. 
LORBENA™ to be withhold until PR interval is less than 200 ms. 

§ 0.2% experienced Grade 3 AV block and underwent pacemaker placement.

Abbreviations: AV, Atrioventricular; CNS, Central nervous system; ILD, Interstitial lung disease; TRAEs, Treatment-related adverse events.

References:Lorbrena™ EDA leaflet approval date 26/4/2021.Bauer TM, Felip E, Solomon BJ, et al. Clinical Management of Adverse Events Associated with Lorlatinib. Oncologist. 2019;24(8):1103-1110Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018;19(12):1654–1667.

MOH Approval No: HF0098OA54/062022
Invalidation date: 12/06/2024

Adverse events should be reported. Adverse events can be reported to [email protected]

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