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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:
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.
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.
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Lysodren (mitotane) tablets may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:
The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.
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:
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.
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.
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.
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:
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.
Nitin Goswami, Senior Medical Content Writer
Shilpi Banerjee, Registered Pharmacist (M.Pharm)
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