Lysodren (Mitotane) – ACC | HongKong DengYue Medicine

Mitotane Application Scope

Indication: Treatment of unresectable, functional or non-functional adrenal cortical carcinoma (ACC).

Mitotane Characteristics

• Ingredients: Mitotane.

• Properties:​

  • Oral antineoplastic agent, derivative of DDT, with adrenolytic activity.

  • Selectively destroys adrenal cortical cells and alters peripheral steroid metabolism.

• Packaging Specification:​ 500 mg tablets × 100 tablets/bottle.

• Storage:​

  • Store below 25 °C in tightly closed container.

  • Keep away from children; protect from moisture.

• Expiry Date: As printed on package.

• Executive Standard: ​Per registered pharmacopoeia/marketed product standard.

• Approval Number: As indicated on approval document.

• Date of Revision: As shown on label/package insert.

• Manufacturer: Laboratoire HRA Pharma (France).

Guidelines for the Use of Lysodren

• Dosage and Administration:

  • Recommended Dose:

    • Initial: 2–6 g/day orally, divided into 2–3 doses.

    • Maintenance: up to 8–10 g/day, adjusted by tolerance and plasma concentration.

  • Administration: Oral use; swallow tablets whole with water; preferably with food (fat-rich meals improve absorption).

  • Missed Dose:​ If a dose is missed, take the next scheduled dose. Do not double.

• Adverse Reactions:

  • Common Adverse Reactions: Nausea, vomiting, diarrhea, anorexia, dizziness, ataxia, confusion, lethargy, rash.

  • Serious Adverse Reactions: Neurotoxicity (ataxia, speech disorder, cognitive impairment), leukopenia, prolonged bleeding time, hepatotoxicity, adrenal insufficiency.

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• Contraindications:

  • Hypersensitivity to mitotane or excipients.

  • Pregnancy (teratogenic risk).

  • Breastfeeding.

• Precautions:

  • Monitor plasma mitotane levels regularly.

  • Monitor liver function, blood counts, lipid profile, neurological status.

  • Contraception required during and after treatment (both genders).

  • Adrenal replacement therapy often required due to adrenal destruction.

  • Caution with activities requiring alertness (neurotoxic effects).

Mitotane Interactions

• CYP3A4 inducer → reduces plasma concentrations of many drugs (e.g., warfarin, phenytoin, rifampicin, oral contraceptives, tyrosine kinase inhibitors).

• Increases metabolism of corticosteroids → higher doses may be required.

• Avoid alcohol (enhances CNS toxicity).

• Use caution with drugs having narrow therapeutic index.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.