This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

Zepzelca (lurbinectedin)

General Description:

Zepzelca (lurbinectedin) is a prescription medication used to treat adult patients with metastatic small cell lung cancer (SCLC) whose disease has progressed following treatment with platinum-based chemotherapy.

GettingZepzelca (lurbinectedin)in India

Zepzelca (lurbinectedin) has been approved in countries like the U.S. and Europe but is not yet available for commercial sale in India. However, it is accessible through the Named Patient Program (NPP) for eligible patients.

MitoGENE helps Indian patients access Zepzelca (lurbinectedin)legally and safely under their doctor’s supervision. We handle the documentation, regulatory approvals, and logistics to ensure compliance with Indian regulations.

If you or your loved one may benefit from Zepzelca (lurbinectedin), MitoGENE is here to support your journey to access this treatment.

Disease Indications:Lung Cancer

Manufacturer:Jazz Pharmaceuticals

Usage:Intravenous

Medicine Approved by:

  • Food and Drug Administration (FDA)

Available Dosage Form& Package

  • Single-dose vial x 4 mg (lyophilized powder)

Shipping:Cold Chain Shipping. Certain medicines can be affected by heat, light, or improper handling. Cold chain shipping uses temperature-controlled packaging and transport provided by specialized medical couriers to keep these medicines stable and effective. Due to the added care and equipment involved, this method is often more expensive than standard shipping.

What is Zepzelca (lurbinectedin) used for?

Zepzelca (lurbinectedin) is a chemotherapy drug indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC)—cancer that has spread to other parts of the body—after disease progression following platinum-based chemotherapy.[1]

It is supplied in single-dose vials containing 4 mg of lurbinectedin.

How does Zepzelca (lurbinectedin) work?

Lurbinectedin functions as an alkylating agent. It binds to guanine bases in DNA, disrupting the DNA structure and preventing normal function and replication.[1,2]

By attaching to multiple guanine sites, lurbinectedin interferes with essential cellular processes, leading to DNA strand breaks. This results in cancer cell damage and eventually cell death, helping to slow tumor growth and promote tumor shrinkage.[2]

Where is Zepzelca approved?

Zepzelca received accelerated approval from the U.S. Food and Drug Administration (FDA) on June 15, 2020, for adults with metastatic SCLC whose disease has progressed following platinum-based chemotherapy.[3]

Note: Zepzelca may also be approved in other regions. For approval status in a specific country, please contact our support team.

What are the side effects of Zepzelca?

Common side effects (≥20% of patients) include:[1]

  • Fatigue
  • Low white/red blood cell counts
  • Elevated creatinine (kidney function marker)
  • Abnormal liver function tests
  • High blood sugar
  • Nausea, vomiting, constipation, or diarrhea
  • Loss of appetite
  • Muscle and joint pain
  • Low albumin levels
  • Breathing difficulty, cough
  • Low sodium and magnesium levels

Serious side effects may include:[1]

  • Severe neutropenia (low white blood cell count)
  • Liver toxicity

Use in specific populations

Zepzelca can cause harm to an unborn baby. Pregnancy and breastfeeding should be avoided during treatment.[1]

Refer to the official prescribing information for a complete list of adverse effects and precautions.

References

1. Full prescribing information [FDA]: Zepzelca (lurbinectedin) [PDF]
Jazz Pharma, June 2020

2. Types of Chemotherapy Agents and Regimens – Alkylating agents
Last checked Jul 20, 2020

3. FDA Approves Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer
Press release June 15, 2020

4. Zepzelca Dosage and Administration
Last checked Jul 20, 2020

How to Access Zepzelca (lurbinectedin) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If Zepzelca (lurbinectedin) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.