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.”

LYSODERN (Mitotane)

General Description:

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

Getting Lysodren (mitotane) in India

Lysodren (mitotane) is approved for medical use in the U.S., Europe, and other countries, but is not commercially sold in India. However, Indian patients who require this life-saving treatment can legally access Lysodren through the Named Patient Program (NPP).

MitoGENE helps eligible patients and their physicians navigate the legal and regulatory process to import Lysodren safely and compliantly into India. We assist with the required documentation, facilitate the importation process, and coordinate secure delivery while ensuring full regulatory adherence.

If you or a loved one has been prescribed Lysodren, MitoGENE is here to support you every step of the way.

Disease Indications:Adrenocortical Carcinoma (ACC)

Manufacturer:HRA Pharma Rare Diseases

Usage:Oral

Medicine Approved by:

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

Available Dosage Form & Package:

  • Tablets, 500 mg

Shipping:

Room Temperature Shipping. This medication is shipped using standard delivery methods, ensuring that it remains within a controlled temperature range (15°C to 25°C) during transit.

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. TGA Australia – Lysodren Access Pathway.
  2. U.S. FDA – Lysodren Prescribing Information. Accessed May 2025.
  3. EMA – Lysodren EPAR Summary. European Medicines Agency. Accessed May 2025.
  4. HRA Pharma Rare Diseases – Official Product Information.
  5. National Cancer Institute – Adrenocortical Carcinoma Treatment Guidelines.
  6. Canadian Drug Product Database – Lysodren Approval.

How to Access Lysodren (mitotane) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)

If Lysodren (mitotane) is not available in India commercially, MitoGENE can help you access it legally under 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.