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Adverse event reporting can be found at the bottom of the page
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The content of this webpage has been produced in line with the LORVIQUA®▼ (lorlatinib) Summary of Product Characteristics for Great Britain.
If you are an HCP in Northern Ireland click here.
LORVIQUA®▼ (lorlatinib) Prescribing Information for Great Britain and Northern Ireland click here. XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
LORVIQUA® is generally well tolerated and has a manageable safety profile.1,2
The most frequently reported adverse reactions (all grade events occuring in more than 20% of patients) in patients treated with LORVIQUA® 100mg once daily in the Phase I/II Study A (n=327) and Phase 3 CROWN study (n=140) were:1
| Most Frequently Reported Adverse Reaction | All Grade Adverse Events | Grade 3-4 Adverse Events |
|---|---|---|
| Hypercholesterolaemia | 81.1% | 18.3% |
| Hypertriglyceridaemia | 67.2% | 19.3% |
| Oedema | 55.7% | 2.7% |
| Peripheral neuropathy | 43.7% | 2.7% |
| Weight increased | 30.9% | 10.1% |
| Cognitive effects | 27.7% | 2.9% |
| Fatigue | 27.3% | 1.3% |
| Dyspnoea | 26.9% | 5.5% |
| Arthralgia | 23.5% | 0.8% |
| Diarrhoea | 22.9% | 1.5% |
| Mood effects | 21.0% | 1.5% |
| Cough | 20.6% | 0% |
Dose reductions due to adverse events (AEs) were reported in 24.6% of patients.1
Permanent discontinuations due to AEs ocurred in 9.2% of patients.1
The most frequent adverse reactions that led to permanent discontinuations were cognitive effects, peripheral neuropathy and pneumonitis.1
For the most up-to-date safety information and full information on dose modifications and the management of treatment related adverse events, please refer to the LORVIQUA® Summary of Product Characteristics.
LORVIQUA®▼(lorlatinib) Prescribing Information for Great Britain and Northern Ireland click here.
XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here.
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PP-UNP-GBR-7812. January 2024