Lurbinectedin binds to DNA, disrupting transcription and repair pathways, inhibiting monocyte activity, reducing tumor-associated macrophages, and ultimately causing cancer cell death.
Lurbinectedin
Generic Name/API:Lurbinectedin
Packaging:ZEPZELCA (lurbinectedin) for injection is supplied as a sterile, preservative-free, white to off white lyophilized powder in a single-dose clear glass vial. Each carton contains 4 mg in one single-dose vial.
Storage:Store refrigerated at 2° to 8°C (36° to 46°F)
Dosage:For dosage information, please check the General Information section.
Strength:For injection: 4 mg of lurbinectedin as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial for reconstitution prior to intravenous infusion.
Indication:ZEPZELCA® (lurbinectedin) is an alkylating agent approved for the treatment of adults with metastatic small cell lung cancer (SCLC) whose disease has progressed following platinum-based chemotherapy.
ZEPZELCA® (lurbinectedin) is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has progressed and metastasized even after receiving platinum based chemotherapy. It is a unique DNA-binding alkylating agent that disrupts transcription and DNA repair pathways, leading to cancer cell death.
STRENGTH:
For injection: 4 mg of lurbinectedin as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial for reconstitution prior to intravenous infusion.
DOSAGE:
Recommended Dosage
The recommended dosage of lurbinectedin is 3.2 mg/m2 by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity. Initiate treatment with lurbinectedin only if absolute neutrophil count (ANC) is at least 1,500 cells/mm3 and platelet count is at least 100,000/mm3.
| Dose reduction | Total dose |
| First | 2.6 mg/m2 every 21 days |
| Second | 2 mg/m2 every 21 days |
Dosage modifications for adverse reactions
Permanently discontinue ZEPZELCA in patients who are unable to tolerate 2 mg/m2 or require a dose delay greater than two weeks.
| Adverse reactions | Severity | Dosage modifications |
| Neutropenia | Grade 4 or any grade febrile neutropenia |
|
| Thrombocytopenia | Grade 3 with bleeding or grade 4 |
|
| Hepatotoxicity | Grade 2 |
|
| Grade ≥ 3 |
|
SIDE EFFECTS:
Following are the clinically significant adverse reactions:
- Myelosuppression
- Hepatotoxicity
STORAGE:
- Store refrigerated at 2° to 8°C (36° to 46°F).
- Lurbinectedin is a hazardous drug. It is advised to follow applicable special handling and disposal procedures.
The following adverse reactions and their severity as mentioned were observed in patients with advanced solid tumours under treatment with lurbinectedin:
- Myelosuppression: Lurbinectedin can cause myelosuppression. In clinical studies, Grade 3 or 4 neutropenia occurred in 41% (median onset: 15 days; duration: 7 days), febrile neutropenia in 7%, and sepsis in 2% (1% fatal, none in SCLC). Grade 3 or 4 thrombocytopenia and anemia occurred in 10% and 17% of patients, respectively. Administer lurbinectedin only to patients with baseline neutrophil count of at least 1,500 cells/mm3 and platelet count of at least 100,000/mm3. Monitor blood counts with neutrophil and platelet count before each administration. For neutrophil count less than 500 cells/mm3 or any value less than lower limit of normal, the use of G-CSF is recommended.
- Hepatotoxicity: In clinical studies, serious liver enzyme elevations (Grade ≥3 ALT/AST) occurred in up to 6% of patients, usually starting around day 8 and lasting about a week. It is advised to monitor liver function tests, prior to initiating treatment, periodically during treatment, and as clinically indicated.
- Embryo-fetal toxicity: Based on animal data and its mechanism of action lurbinectedin can cause fetal harm when administered to a pregnant woman. Embryolethality was observed in animal studies with rats.
For all above mentioned adverse reactions, withhold, reduce the dose, or permanently discontinue lurbinectedin based on severity.
FAQ
What is lurbinectedin used for?
ZEPZELCA® (lurbinectedin) is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC) that has progressed and metastasized even after receiving platinum based chemotherapy.
What are the common side effects of lurbinectedin use?
The primary side effects of lurbinectedin include hepatotoxicity, myelosuppression and embryo-fetal toxicity.
Can lurbinectedin be used in specific populations i.e. for pregnant, breastfeeding , pediatric and geriatric use?
Based on animal data and its mechanism of action, lurbinectedin can cause fetal harm when administered to a pregnant woman. There are no available data to inform the risk of use in pregnant women. Animal studies show a chance of embryolethality.
What is the cost of lurbinectedin (zepzelca) in India?
The cost of lurbinectedin (zepzelca) in India varies as it must be imported, since it’s not approved for local sale. Factors like supplier availability, import fees, and currency fluctuations affect final pricing. For up-to-date cost details, contact 24/7QualityMeds at +91 9967979080.
How to buy lurbinectedin (Zepzelca) injection online in India?
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