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LORBRIQUA® (lorlatinib) is indicated for the treatment of adult patients with ALK+ metastatic NSCLC.1

CNS Effects

A broad spectrum of CNS effects can occur in patients receiving LORBRIQUA®   (lorlatinib)1-3

  • The CNS effects include seizures, psychotic effects and changes in cognitive function, mood (including suicidal ideation), speech, mental status and sleep
         ​​
  • Patients should be assessed for mood and cognitive functions before initiating treatment with LORBRIQUA®, and should be monitored by the entire healthcare team and their carer(s) during treatment
     
  • Patients without a primary carer should receive frequent calls and be referred to resources such as therapists or social workers
     
  • Concomitant medications should be considered as a potential contributing factor
     
  • In the pooled data from the CROWN and Phase 1/2 trials, 2.1% of patients required permanent discontinuation of LORBRIQUA® due to CNS effects, 10% of patients required temporary discontinuation and 8% of patients required dose reduction

Dosage Modification Guidance for CNS Effects
 

  

The data in the Warnings and Precautions section of the Prescribing Information reflect exposure to LORBRIQUA® in 476 patients who received 100-mg LORBRIQUA® QD in Study B7461001 (N=327) and in Study B7461006 (N=149).​​​​​

   

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H4 (Mobile)

   

*Grade based on the NCI CTCAE version 4.03.

   

 ALK+, anaplastic lymphoma kinase-positive; CNS, central nervous system; CTCAE, Common Terminology Criteria for Adverse Events; NCI, National Cancer Institute; NSCLC, non-small cell lung cancer; QD, once a day.

   

References:

Lorbriqua. Local product document. Pfizer; 2021. LPD Version 7.0  LPDLOR102022.Bauer TM, Felip E, Solomon BJ, et al. Clinical Management of Adverse Events Associated with Lorlatinib. Oncologist. 2019;24(8):1103-1110.Reed M, Rosales ALS, Chioda MD, Parker L, Devgan G, Kettle J. Consensus recommendations for management and counseling of adverse events associated with lorlatinib: a guide for healthcare practitioners.
Adv Ther. 2020;37(6):3019-3030.

   

Please click the Prescribing Information link to view the safety and adverse events information of LORBRIQUA®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.​​​​​​

   

PP-LOR-IND-0129 June 2022

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