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

LORBRENA™ has a generally manageable safety profile with a low discontinuation rate2*

  • In the pooled safety population, the most frequent adverse reactions in ≥ 20% of 476 patients who received LORBRENA™ were edema (56%), peripheral neuropathy (44%), weight gain (31%), cognitive effects (28%), fatigue (27%), dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects (21%), and cough (21%)1
  • The most frequent Grade 3-4 laboratory abnormalities in ≥ 20% of 476 patients who received LORBRENA™ were hypercholesterolemia (21%) and hypertriglyceridemia (21%)1
  • In previously untreated ALK-Positive Metastatic NSCLC (CROWN Study), serious adverse reactions occurred in 34% of patients treated with LORBRENA™; the most frequently reported serious adverse reactions were pneumonia (4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive effects (2.0%), and pyrexia (2.0%)1
  • Fatal adverse reactions occurred in 3.4% of patients treated with LORBRENA™ and included pneumonia (0.7%), respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary embolism (0.7%), and sudden death (0.7%)1
  • Permanent discontinuation of LORBRENA™ due to adverse reactions occurred in 6.7% of patients1
  • Adverse reactions leading to dose interruptions occurred in 49% of patients treated with LORBRENA™1
  • Adverse reactions leading to dose reductions occurred in 21% of patients treated with LORBRENA™1
  • In previously treated ALK-Positive Metastatic NSCLC, serious adverse reactions occurred in 32% of the 295 patients; the most frequently reported serious adverse reactions were pneumonia (3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%), and respiratory failure (1.4%)1
  • Permanent discontinuation of LORBRENA™ for adverse reactions occurred in 8% of patients1
  • Approximately 24% of patients required at least 1 dose reduction for adverse reactions1

Refer to the LORBRENA™ Local Product Document for the most up-to-date safety profile.
*All patients included in the safety analysis received at least one dose of LORBRENATM.2

Abbreviations: AST, Aspartate aminotransferase; ALK, Anaplastic lymphoma kinase; NSCLC: non-small cell lung cancer.

References:Lorbrena™ EDA leaflet approval date 26/4/2021.Solomon 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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