TM Owner PharmaMar / Jazz Pharmaceuticals
Zepzelca 4mg Vial
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Indications & Clinical Uses
- Zepzelca 4mg (lurbinectedin) is a cytotoxic (chemotherapy) medicine supplied as a single-dose 4 mg lyophilised powder vial for intravenous infusion.
- In the US it is approved in two settings for adults with small cell lung cancer (SCLC): as maintenance treatment, in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for extensive-stage SCLC whose disease has not progressed after first-line induction with atezolizumab (or atezolizumab and hyaluronidase-tqjs), carboplatin and etoposide; and as treatment for metastatic SCLC with disease progression on or after platinum-based chemotherapy, which was an accelerated approval.
- The recommended dose is 3.2 mg/m2 as an intravenous infusion every 21 days until disease progression or unacceptable toxicity.
- Zepzelca is prepared and given only by trained healthcare professionals in a hospital or cancer clinic.
- It is marketed in the US by Jazz Pharmaceuticals and was developed by PharmaMar.
Side Effects
- Zepzelca has no boxed warning.
- The most common side effects (20% or more) were low white blood cell and lymphocyte counts, tiredness, low haemoglobin (anaemia), low neutrophils (neutropenia), nausea, raised blood creatinine and raised liver enzyme (ALT).
- In the earlier monotherapy data, 46% of patients had severe (grade 3 to 4) neutropenia.
- Serious risks are myelosuppression (which can cause infections and bleeding), liver toxicity, leakage of the drug outside the vein (extravasation) causing tissue damage and death of tissue, and harm to an unborn baby.
- Tell your care team at once about fever or other signs of infection, unusual bruising or bleeding, yellow skin or eyes, or pain, redness or swelling at the infusion site.
- Blood tests before each cycle help detect problems early.
Precautions & Warnings
- Blood counts are checked before each dose (treatment is delayed unless neutrophils are at least 1,500 per mm3 and platelets at least 100,000 per mm3), and liver tests and creatine phosphokinase (CPK) are checked before starting and periodically.
- Doses are reduced to 2.6 mg/m2 and then 2 mg/m2 for side effects, and to 1.6 mg/m2 in hepatic impairment.
- The label lists no contraindications.
- Because extravasation can damage tissue, monitor the infusion site closely; a central venous catheter may be considered.
- Zepzelca can cause fetal harm: females of reproductive potential should use effective contraception during treatment and for 7 months after the last dose, and males with female partners of reproductive potential for 4 months.
- Avoid breastfeeding during treatment and for 2 weeks after the last dose.
- Unopened vials are stored refrigerated at 2°C to 8°C by the pharmacy.
Avoid Interactions
- Medicines that increase Zepzelca levels and toxicity: strong or moderate CYP3A inhibitors such as ketoconazole, itraconazole and clarithromycin raise lurbinectedin exposure; avoid them, and if a strong or moderate inhibitor cannot be avoided reduce the Zepzelca dose by 50%.
- Medicines that reduce efficacy: CYP3A inducers such as rifampin and phenobarbital lower lurbinectedin exposure and should be avoided.
- Tell your healthcare provider about all prescription and non-prescription medicines, herbal products and supplements you use, so that CYP3A interactions can be checked before every cycle.
- The dose is calculated by body surface area, and Zepzelca must be prepared by a healthcare professional following the label instructions.
References
- ZEPZELCA (lurbinectedin) for injection - US Prescribing Information, DailyMed
- ZEPZELCA (lurbinectedin) - US Prescribing Information (full label view), DailyMed
- ZEPZELCA (lurbinectedin) - initial FDA approval label (2020), Drugs@FDA
- Zepzelca (lurbinectedin) dosing, indications, interactions, adverse effects - Medscape
Frequently Asked Questions
Zepzelca (lurbinectedin) is a chemotherapy given into a vein to treat small cell lung cancer in adults. It is used with atezolizumab as maintenance after first-line treatment for extensive-stage disease, and alone for metastatic disease that progressed on or after platinum-based chemotherapy.
Zepzelca (lurbinectedin) is given by a healthcare professional as an intravenous infusion at 3.2 mg/m2 once every 21 days. Treatment continues until the cancer progresses or side effects become unacceptable. Your dose may be lowered to 2.6 mg/m2, then 2 mg/m2, if side effects occur.
Very common Zepzelca side effects (20% or more) are low white cells, low neutrophils, anaemia, tiredness, nausea, and raised creatinine and liver enzymes. Get help quickly for fever, infection signs, unusual bleeding, yellow skin or eyes, or pain, redness or swelling where the drip enters your arm.
Avoid strong or moderate CYP3A inhibitors, such as ketoconazole, itraconazole and clarithromycin, and CYP3A inducers such as rifampin and phenobarbital, during Zepzelca (lurbinectedin) treatment. If an inhibitor cannot be avoided, the Zepzelca dose is reduced by 50%. Tell your healthcare provider about all your medicines and supplements.
Zepzelca (lurbinectedin) needs a complete blood count before every dose, and treatment waits until neutrophils and platelets have recovered. Liver tests and creatine phosphokinase (CPK) are checked before starting and periodically. These tests catch low blood counts and liver problems early.
No. Zepzelca (lurbinectedin) can harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 7 months after the last dose, and men with partners who could become pregnant for 4 months. Avoid breastfeeding during treatment and for 2 weeks after.
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