Lysodren® (Mitotane)

Lysodren® (Mitotane) Mitotane 500 mg tablets by HRA Pharma. Genuine stock supplied in bulk/wholesale quantities to hospitals and pharmacies across India by A.K. Pharma, a licensed pharmaceutical distributor in Delhi.

Additional information

Composition

Mitotane 500 mg

Manufacturer

HRA Pharma

Country

Austria

Pack size

Mitotane 500 mg: Bottle of 100 tablets per US label; please confirm the pack supplied

Storage

As per bottle and leaflet; original pack

Prescription medicine

Supplied only against a valid prescription from a registered medical practitioner.

100% genuine

Sourced from authorised channels

Cold-chain delivery

Temperature-controlled packing

Pan-India delivery

Hospitals, clinics, pharmacies

Licensed distributor

Delhi drug licence holder

Product information

Lysodren® (Mitotane) Mitotane 500 mg Tablets — Adrenal Cytotoxic Agent: A Sourcing Guide for Hospitals and Oncology Pharmacies

Lysodren® is a brand of mitotane tablets, an adrenal cytotoxic agent. According to the current US prescribing information (DailyMed), Lysodren is indicated for the treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC). The pack image on this page shows older Bristol-Myers Squibb packaging, while the current manufacturer and US label holder is HRA Pharma (with Esteve Pharmaceuticals also listed in the US); indications in India are defined by the approved pack insert and the Indian regulator. The decision to prescribe mitotane, including patient selection, dose and monitoring, rests entirely with the treating physician. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.

As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Lysodren® (mitotane) Mitotane 500 mg tablets to hospitals, oncology centres and pharmacies across India. Buyers comparing pharmaceutical distribution companies and wholesale pharmaceutical distributors can also browse our full product range and the cancer medicines category. Supply is in bulk/wholesale quantities only.


What is Lysodren (Mitotane)?

Lysodren contains mitotane 500 mg per tablet. The US label describes the tablets as white, round, biconvex and scored, supplied in bottles of 100 tablets. Mitotane is lipophilic and accumulates in adipose tissue.

How it works, according to the label: The label describes mitotane as an adrenal cytotoxic agent. It also notes that it can cause adrenal insufficiency (adrenal crisis), which is why the label calls for steroid replacement to be considered by the treating physician.


Indications as Listed in the Reference Label

The current US prescribing information for LYSODREN® (mitotane tablets) (DailyMed) lists the following. Indications in India may differ and are defined by the Indian regulator and the Lysodren pack insert.

  • Treatment of patients with inoperable, functional or nonfunctional, adrenocortical carcinoma (ACC)
  • The label states there are no contraindications listed
  • The label describes dose titration against mitotane plasma levels (14 to 20 mg/L), under the treating physician’s direction
  • The label classes mitotane as a hazardous drug requiring special handling and disposal procedures

Clinical Studies and Evidence

The current US Lysodren label does not carry a dedicated controlled-trial Clinical Studies section. Published literature on mitotane in advanced adrenocortical carcinoma includes the FIRM-ACT randomised trial (Fassnacht et al., New England Journal of Medicine, 2012), which compared etoposide, doxorubicin and cisplatin plus mitotane with streptozocin plus mitotane. It is cited here for information only, not as a recommendation for any patient; the approved prescribing information governs.


Available Presentation

Strength Dosage form Pack size (as shown on the carton)
Mitotane 500 mg Tablets (oral) Bottle of 100 tablets per US label; please confirm the pack supplied

Please confirm the current pack and batch with us before ordering. Dose and regimen must be determined and followed exactly as directed by the treating physician and the approved prescribing information.


Key Benefits for Procurement

  • Genuine, sealed original-pack stock sourced through authorised channels
  • Original manufacturer packaging with batch and expiry details
  • Batch and expiry details provided on request
  • Careful handling and storage of stock before dispatch
  • Documentation support for hospital purchase departments

Who Is This Page For?

This page is written for hospital pharmacists, endocrine oncology department buyers, and pharmacies that source specialty oncology products. Mitotane is prescribed and supervised by a physician, as described in the prescribing information.


Possible Side Effects Reported in the Label

The Lysodren label lists adverse reactions including anorexia, nausea, vomiting, diarrhea, dizziness, vertigo, confusion, headache, ataxia, rash and blood-count changes (leukopenia, anemia, thrombocytopenia). The label warns of adrenal insufficiency and adrenal crisis, central nervous system toxicity, ovarian macrocysts in premenopausal women and hepatotoxicity. This list is not complete; the full prescribing information governs.


Precautions

  • The label lists adrenal insufficiency and adrenal crisis as a warning, particularly with shock, severe injury or infection, as managed by the treating physician.
  • The label describes monitoring of mitotane plasma levels, because levels above 20 mg/L are associated with a greater incidence of toxicity.
  • The label describes monitoring of liver function and neurologic assessments, as determined by the treating physician.
  • The label states that mitotane is a hazardous drug and should be handled and disposed of accordingly.
  • All use should follow the approved prescribing information and the instructions of the treating physician.

All use should follow the approved prescribing information and the instructions of the treating physician.


Storage and Handling

Please follow the storage instructions printed on the Lysodren carton and bottle. For reference, the US label describes storage at 25°C, with excursions permitted between 15°C and 30°C. Keep in the original container, out of reach of children.


Manufacturer Information

Lysodren is marketed by HRA Pharma. A.K. Pharma is a licensed distributor and does not manufacture the product. As one of the pharmaceutical distributors serving Indian hospitals, we source Lysodren through authorised channels and supply it with pack and batch details. Buyers comparing a pharmaceutical wholesale distributors list or a pharma distribution company can verify our credentials on the About Us page.


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Frequently Asked Questions

Is Lysodren available in India?
A.K. Pharma supplies Lysodren (mitotane) Mitotane 500 mg tablets to hospitals and pharmacies in India. Contact us for current availability.

What does Lysodren contain?
Mitotane 500 mg per tablet, an adrenal cytotoxic agent.

Can I order a single pack?
A.K. Pharma is a distributor and supplies bulk/wholesale quantities only, not one or two pieces.

How should Lysodren be stored?
As printed on the carton and bottle, in the original container. The US label describes storage at 25°C.

Does A.K. Pharma advise on dosing or suitability?
No. Treatment decisions, including dosing, rest solely with the treating physician and the approved prescribing information.

How do I request a quote?
Call or WhatsApp us, or use the contact details below.


Why Order from A.K. Pharma

  • Licensed pharmaceutical distributor in Delhi with 25+ years in specialty medicines
  • Genuine, original-pack stock
  • Bulk/wholesale supply to hospitals, oncology centres and pharmacies
  • Batch and expiry details on request
  • Dedicated team for hospital procurement queries

Sources and Further Reading


Contact A.K. Pharma for Lysodren Supply

📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052
📞 011 4172 6999
📱 WhatsApp: +91 9810034827
🌐 akpharma.in


Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. A.K. Pharma is a licensed medicine distributor, not a healthcare provider, and does not provide clinical guidance. All treatment decisions, including drug selection and dosing, rest solely with the treating physician and should follow the approved prescribing information.

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