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Lysodren

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Lysodren

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Medicine Name: Lysodren
Generic Name (API): Mitotane
Dosage Form & Strength: 500 mg
Route: Oral
Drug Class: Oral adrenal cytotoxic (adrenolytic) agent — antineoplastic

Manufacturer / Innovator:

France

Regulatory Approval:

  • FDA (US)
  • EMA (Europe)
  • NMPA (China)
  • and others
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What Is Lysodren Used For?

Lysodren (mitotane) is an oral adrenal cytotoxic agent — the only medicine specifically approved by both the US FDA and the European Medicines Agency for adrenocortical carcinoma. It acts directly on the adrenal cortex, selectively damaging and suppressing adrenocortical cells, and also alters peripheral steroid metabolism, reducing measurable levels of 17-hydroxycorticosteroids. Because of this adrenolytic effect, most patients on Lysodren develop adrenal insufficiency and require lifelong corticosteroid replacement alongside treatment. Lysodren is indicated for the:

  • Treatment of patients with inoperable, functional or nonfunctional adrenocortical carcinoma (ACC).

Lysodren is a prescription cytotoxic anticancer medicine. Treatment must be initiated and supervised by a physician experienced in the management of adrenocortical carcinoma, with access to therapeutic drug monitoring.

Recommended Dosage

The recommended starting dose of Lysodren is 2 g to 6 g orally per day, given in three or four divided doses. The dose is then increased incrementally to achieve a plasma mitotane concentration of 14 to 20 mg/L, or as tolerated. This therapeutic window is central to treatment: concentrations below 14 mg/L are generally considered subtherapeutic, while concentrations above 20 mg/L are associated with a markedly greater incidence of toxicity.

Tablets should be swallowed whole with food and must not be crushed, chewed, or split. The timing of doses relative to meals should be kept consistent, as administration with high-fat food enhances absorption. If a dose is missed, the next dose should be taken as scheduled — the dose should not be doubled.

Plasma mitotane levels should be measured regularly during dose titration and thereafter, and monitoring should continue even when Lysodren has been temporarily withheld, because mitotane accumulates in adipose tissue and continues to be released from it. Close monitoring is particularly important in overweight patients and in patients with recent weight loss. Specialist laboratory services for plasma mitotane monitoring are available internationally and can be coordinated as part of the access pathway.

Because Lysodren causes adrenal insufficiency in most patients, corticosteroid replacement therapy is generally required. Free cortisol and corticotropin (ACTH) levels should be measured to guide optimal steroid replacement.

Treatment should be temporarily withheld in the setting of shock, severe trauma, or infection, and exogenous steroids administered. In patients with mild or moderate renal impairment, mitotane plasma levels should be monitored frequently and the dose adjusted as needed.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Lysodren Warnings and Precautions

  • Treatment with Lysodren increases the risk of life-threatening adrenal crisis during shock, severe trauma, or infection. Temporarily stop treatment, administer steroid replacement, monitor closely, and immediately inform all healthcare providers about any illness, injury, or planned surgery.
  • This medicine may cause or worsen adrenal insufficiency in patients with adrenocortical carcinoma. Steroid replacement therapy should be initiated when clinically required, with regular monitoring of free cortisol and ACTH levels throughout treatment.
  • Lysodren may cause sedation, dizziness, lethargy, or vertigo, especially when plasma concentrations exceed 20 mg/L. Regular neurological assessment and plasma monitoring are recommended. Avoid driving or operating machinery if symptoms develop.
  • Premenopausal women receiving Lysodren may develop ovarian macrocysts. Pelvic ultrasound should be performed before treatment and periodically thereafter. Promptly report abdominal or pelvic pain and abnormal vaginal bleeding to your healthcare provider.
  • This therapeutic drug can harm an unborn baby and has been associated with adverse pregnancy outcomes. Use effective contraception during and after treatment, confirm pregnancy status before therapy, and avoid breastfeeding while receiving Lysodren.
  • Lysodren strongly induces CYP3A4, reducing the effectiveness of many medicines. Avoid concurrent use with spironolactone and warfarin. Inform your healthcare provider about all prescription medicines, over-the-counter drugs, and dietary supplements you take.
  • Lysodren is a hazardous cytotoxic medicine. Wear disposable gloves when handling tablets, avoid contact with broken tablets, wash exposed skin immediately, and never use tablets showing signs of damage or deterioration.

How to Access Lysodren in India: A 6-Step Process

  • Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
  • Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
  • Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
  • Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
  • Step 5 – Compliant import & handling: The medicine is sourced and transported under strict GDP-compliant, controlled-temperature conditions, with cytotoxic handling precautions, to maintain product integrity.
  • Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

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Documentation & Availability

What documents are required to import Lysodren to India?

Lysodren (mitotane) tablets may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:

  • A valid prescription from a qualified doctor
  • The patient's diagnostic reports, including histopathology or imaging confirming adrenocortical carcinoma
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is Lysodren available in India?

Lysodren (mitotane tablets) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, Lysodren is not commercially marketed or registered in India.

However, patients in India can legally access Lysodren through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

NamedPatientProgram.com (NPP) acts as a facilitator under named patient supply, providing input on:

  • Availability of Lysodren in India and pathways to access it
  • Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE)
  • Lysodren price in India under the NPP route
  • Sourcing from genuine, reliable channels in the USA, Europe, China, Singapore, Canada, and Australia
  • Ensuring full transparency throughout the process

Lysodren can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only upon receipt of a valid doctor's prescription and, where applicable, an import permit.

Sourcing & Delivery of Lysodren

NamedPatientProgram.com (NPP) can source Lysodren from reliable global manufacturers and qualified pharmaceutical supply channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. Lysodren is an oral solid dosage form shipped under GDP-compliant controlled room-temperature conditions, with cytotoxic handling protocols observed through packing, transit, and dispensing, and full batch traceability maintained end to end.

Because treatment is long-term and dose titration is guided by plasma mitotane levels, continuity of supply matters. NPP can coordinate scheduled repeat consignments so that therapy is not interrupted during titration or maintenance.

All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Lysodren cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability of Lysodren® Across Major Cities in India

Patients across India can access Lysodren® through regulated import pathways, with delivery arranged to the treating hospital or patient based on a valid specialist's prescription.

Mumbai: A major oncology and endocrinology hub with institutions like Tata Memorial, Mumbai manages a significant share of India's adrenocortical carcinoma referrals and supports access to specialised imported therapies.

Bangalore: With a growing network of multispecialty hospitals and endocrine surgery units, Bangalore supports access to global rare-cancer treatments through structured import pathways guided by treating specialists.

Delhi: As part of the Delhi NCR region, the city has a strong concentration of endocrinology and medical oncology departments, making it a key location for accessing advanced imported therapies.

Gurgaon: Home to leading hospitals like Medanta, Gurgaon plays an important role in facilitating access to innovative rare cancer treatments through coordinated care pathways.

Noida: With proximity to Delhi and access to top hospitals, Noida patients benefit from streamlined logistics and specialist-driven treatment planning.

Hyderabad: Hyderabad's advanced healthcare infrastructure and endocrine oncology expertise support patients seeking access to internationally approved cancer therapies.

Chennai: Known for its established medical ecosystem, Chennai attracts patients from across India for complex endocrine tumour management and specialized drug access.

Kolkata: A key eastern healthcare hub, Kolkata offers access to advanced endocrinology and oncology care through leading hospitals and treatment centers.

Ahmedabad: Ahmedabad's expanding healthcare sector and oncology facilities support patients requiring advanced and imported cancer therapies.

Pune: With reputed hospitals and a growing cancer care infrastructure, Pune is an emerging center for access to specialized endocrine oncology treatments.

Chandigarh: Serving North India, Chandigarh provides access to advanced endocrinology and oncology care through reputed institutions and specialist-led treatment planning.

Jaipur: Jaipur's improving healthcare network enables patients to explore access to innovative rare cancer therapies through structured import processes.

Lucknow: As a major city in North India, Lucknow supports access to advanced endocrine oncology treatment through both public and private healthcare institutions.

Indore: Indore is emerging as a regional healthcare hub, offering access to specialized cancer care and modern treatment pathways.

Bhopal: Patients in Bhopal can access advanced cancer treatments through the growing healthcare infrastructure and referral networks.

Nagpur: Nagpur serves as a central hub for patients across Vidarbha, with increasing access to oncology care and specialized therapies.

Surat: Surat's developing healthcare ecosystem supports patients seeking access to global oncology treatments through coordinated care.

Patna: As a major city in Eastern India, Patna provides growing access to cancer treatment through expanding hospital networks.

Coimbatore: Coimbatore is known for quality healthcare services, offering access to advanced oncology treatments in South India.

Kochi: With modern hospitals and specialist care, Kochi enables patients to explore access to internationally approved cancer therapies.

Note: Access timelines may vary depending on documentation, regulatory approvals, and sourcing logistics.

Access/Buy Lysodren® at Leading Hospitals in India

Lysodren® is used in endocrine oncology settings where surgery, endocrinology, and medical oncology teams work together, and can be accessed at leading hospitals across India, where specialists guide treatment decisions and coordinate patient-specific access pathways.

Major Hospitals Covered:

  • Tata Memorial Centre: One of India's premier cancer institutes, Tata Memorial manages complex endocrine and adrenal malignancies and guides patients toward specialised therapies like Lysodren®.
  • AIIMS: As a leading government medical institution, AIIMS provides comprehensive endocrinology, endocrine surgery and oncology services and supports patients requiring access to rare-disease treatments.
  • PGIMER Chandigarh: A premier North Indian institute with established endocrinology and endocrine surgery departments managing adrenal tumours and long-term mitotane therapy.
  • SGPGIMS Lucknow: Known for its dedicated endocrinology and endocrine surgery department, SGPGIMS is a national referral centre for adrenal disorders and adrenocortical carcinoma.
  • Christian Medical College (CMC) Vellore: CMC Vellore is a nationally recognised referral centre for complex endocrine tumour management and multidisciplinary adrenal care.
  • Apollo Hospitals: With a nationwide presence, Apollo Hospitals offers advanced oncology and endocrinology services and facilitates access to global treatment options through its extensive medical network.
  • Fortis Healthcare: Fortis hospitals are equipped with modern cancer care facilities and multidisciplinary teams that manage complex treatment pathways for patients.
  • Max Healthcare: Max Healthcare is known for its strong oncology and endocrinology departments, providing access to innovative therapies under expert clinical supervision.
  • Manipal Hospitals: Manipal Hospitals supports advanced cancer and endocrine care through experienced specialists and structured treatment planning across multiple cities.
  • Kokilaben Dhirubhai Ambani Hospital: A leading private hospital in Mumbai, Kokilaben Hospital offers cutting-edge oncology care and access to advanced global therapies.
  • Medanta – The Medicity: Medanta is a renowned super-specialty hospital where complex endocrine and oncology cases are managed with advanced treatment protocols and global access support.
  • BLK-Max Super Speciality Hospital: BLK-Max provides comprehensive oncology and endocrine services and supports patients seeking access to specialized treatment options.
  • Rajiv Gandhi Cancer Institute: A dedicated cancer care center, RGCI focuses on advanced oncology treatments and supports patients through complex treatment journeys.
  • HCG Cancer Centre: HCG is a specialized cancer hospital network known for its focus on precision oncology and advanced treatment modalities.
  • Narayana Health: Narayana Health combines affordability with advanced medical care, offering oncology and endocrinology services across multiple locations in India.
  • Amrita Hospital: Amrita Hospital provides high-quality cancer and endocrine care with a focus on patient-centric treatment and access to modern therapies.
  • Yashoda Hospitals: Yashoda Hospitals are known for their strong oncology departments and advanced treatment infrastructure in South India.
  • Aster Hospitals: Aster Hospitals offer integrated cancer care services and support access to innovative therapies through coordinated treatment planning.
  • Sir Ganga Ram Hospital: A well-established hospital in Delhi, Sir Ganga Ram provides multidisciplinary endocrine and cancer care supported by experienced specialists.
  • CARE Hospitals: CARE Hospitals provide modern oncology and endocrinology treatment facilities and multidisciplinary care across multiple cities.

Note: Lysodren® is not stocked for direct purchase but is arranged through compliant import processes and delivered to the patient or hospital for patient-specific treatment.

Written By:

Nitin Goswami, Senior Medical Content Writer

Medically Reviewed By:

Shilpi Banerjee, Registered Pharmacist (M.Pharm)

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