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.”

MitoGENE helps Indian patients access LYSODERN (Mitotane) legally and safely under their doctor’s supervision.

Available Dosage Form& Package

  • 100 Tablets of 500 mg

Shipping: Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring it remains within a controlled room temperature range of 15°C to 25°C throughout transit.

LYSODERN (Mitotane)

Access LYSODERN (Mitotane) in India

LYSODERN (Mitotane) 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 personal use to eligible patients.

MitoGENE helps Indian patients access LYSODERN (Mitotane) 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 LYSODERN (Mitotane), MitoGENE is here to support your journey to access this treatment.

Product Description:

Lysodren (mitotane) is used for the treatment of inoperable, functional or non-functional adrenocortical carcinoma (ACC), a rare cancer of the adrenal cortex.

Disease Indications: Adrenocortical Carcinoma (ACC)

Manufacturer: HRA Pharma Rare Diseases

Medicine Approved by:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Other national agencies (including Canada and Australia)

What is Lysodren (mitotane)?

Lysodren is a prescription oral medication used to treat advanced adrenocortical carcinoma (ACC) when the cancer cannot be surgically removed. It is classified as an adrenolytic agent.

This medicine helps to control symptoms by lowering hormone production from the adrenal glands and slowing the growth of adrenal cancer cells.

How does Lysodren work?

Lysodren contains mitotane, which selectively destroys adrenal cortex tissue and suppresses adrenal hormone production. This makes it particularly useful for treating both functional and non-functional forms of adrenocortical carcinoma.

By inhibiting steroidogenesis and causing necrosis of adrenal cells, Lysodren helps reduce tumor burden and manage hormone-related symptoms associated with ACC.

Where is Lysodren approved?

Lysodren has received regulatory approval in several countries:

  • U.S. FDA – Approved for treatment of adrenocortical carcinoma
  • European Medicines Agency (EMA) – Approved in the European Union
  • Health Canada – Approved for patients with ACC
  • Australia TGA – Listed in the Special Access Scheme

Note: Additional country-specific approvals may exist. Please consult your doctor for availability in your region.

What are the possible side effects?

Common side effects of Lysodren may include:

  • Nausea and vomiting
  • Dizziness
  • Loss of appetite
  • Diarrhea
  • Fatigue
  • Skin rash
  • Impaired adrenal function (may require steroid replacement therapy)

Important: Mitotane can cause adrenal insufficiency. Patients should be closely monitored, and corticosteroid supplementation is often necessary.

Note: Always consult your treating physician to confirm whether Lysodren is suitable for your specific condition. Your doctor will evaluate your disease stage, other treatments tried, and overall health status before recommending this medication.

References

  1. U.S. FDA – Lysodren Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016885Orig1s032lbl.pdf
  2. EMA – Lysodren EPAR Summary (European Medicines Agency) https://www.ema.europa.eu/en/medicines/human/EPAR/lysodren
  3. HRA Pharma Rare Diseases – Official Product Information (EU Register) https://ec.europa.eu/health/documents/community-register/2021/20210322150898/anx_150898_en.pdf
  4. National Cancer Institute – Adrenocortical Carcinoma Treatment Guidelines https://www.cancer.gov/types/adrenocortical/patient/adrenocortical-treatment-pdq
  5. Canadian Drug Product Database – Lysodren https://health-products.canada.ca/dpd-bdpp/info?code=3348&lang=eng
  6. TGA Australia – Special Access Scheme (for unapproved drugs) https://www.tga.gov.au/services/unapproved-products-individual-patients-special-access-scheme

Disclaimer: Lysodren (mitotane) is not approved for commercial sale in India. Access is provided strictly for personal use under physician supervision in accordance with Indian regulatory guidelines through the Named Patient Program (NPP). MitoGENE does not market, advertise, or sell unapproved drugs. All content is for informational purposes and not a substitute for professional medical advice.

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

If LYSODERN (Mitotane) 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:

Process to Import LYSODERN (Mitotane) in India legally through Named Patient Program approved by CDSCO
Process to Import LYSODERN (Mitotane) in India legally through Named Patient Program approved by CDSCO
Process to Import LYSODERN (Mitotane) in India legally through Named Patient Program approved by CDSCO
Process to Import LYSODERN (Mitotane) in India legally through Named Patient Program approved by CDSCO

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    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.