Important safety information
Indications and clinical use:
PrZEPZELCA® (lurbinectedin) is indicated for the treatment of adult patients with Stage III or metastatic SCLC (small cell lung cancer) who have progressed on or after platinum-containing therapy.
The marketing authorization with conditions was based on overall response rate and duration of response; no overall survival benefit has been demonstrated.
Pediatrics: Not indicated for pediatric use.
Geriatrics: In the clinical trial, there was a higher incidence of serious adverse reactions in patients ≥ 65 years of age than in patients < 65 years of age.
Most serious warnings and precautions:
Experience: ZEPZELCA should be administered under the supervision of a physician who is experienced in the use of cancer chemotherapeutics.
Risk of extravasation: Consider use of a central venous catheter to reduce risk of extravasation with ZEPZELCA.
Myelosuppression: Fatal cases observed. Administer ZEPZELCA only to patients with baseline neutrophil count of
≥ 1,500 cells/mm3 (1.5 x 109/L) and platelet count ≥ 100,000/mm3 (100 x 109/L). In case of neutrophil counts < 500 cells/mm3 (0.5 x 109/L) or less than the lower limit of normal, the use of G-CSF (granulocyte colony-stimulating factor) is recommended.
Embryofetal toxicity: ZEPZELCA can cause fetal harm when administered to a pregnant woman. Animal studies in pregnant rats during the period of organogenesis reported embryofetal lethality and maternal toxicity following administration of a single intravenous dose.
Injection site reactions: Extravasation of ZEPZELCA resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur.
Other relevant warnings and precautions:
- Genotoxicity.
- Driving and operating machinery.
- Liver function monitoring.
- Complete blood count monitoring.
- Peripheral neuropathy monitoring.
- Use in patients of reproductive potential or with partners of reproductive potential.
- Consider more frequent laboratory monitoring in patients who are > 75 years of age, have poor performance status, have low blood albumin levels, or are of low weight or have low body surface area.
For more information:
Please consult the Product Monograph at
https://pp.jazzpharma.com/pi/zepzelca.ca.PM-en.pdf for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece.
The Product Monograph is also available by calling us at 1-800-520-5568.
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