Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany
As palliative or supplementary treatment, usually in combination with radiotherapy and/or surgery as part of multiple drug regimens in:
Lomustine “medac” may also be of value as second-line treatment in Non-Hodgkin’s lymphoma, myelomatosis, gastrointestinal tumours, carcinoma of the kidney, the testis, the ovary, the cervix uteri and the breast.
Lomustine “medac” is given by mouth. The recommended dose in patients with normally functioning bone marrow receiving Lomustine “medac” as their only chemotherapy is 120–130 mg/m² as a single dose every six to eight weeks (or as a divided dose over 3 days, e.g. 40 mg/m²/day).
Dosage is reduced:
Marrow depression after Lomustine “medac” is sustained longer than after nitrogen mustards and recovery of white cell and platelet counts may not occur for six weeks or more. Blood elements depressed below the above levels should be allowed to recover to 4,000/mm³ (WBC) and 100,000/mm³ (platelets) before repeating Lomustine “medac” dosage.
Until further data is available, administration of Lomustine “medac” to children with malignancies other than brain tumours should be restricted to specialised centres and exceptional situations. Dosage in children, like that in adults, is based on body surface area (120-130 mg/m² every six to eight weeks, with the same qualifications as apply to adults).
Lomustine “medac” is given by mouth.
Accidental overdose with lomustine has been reported, including fatal cases. Symptoms of overdose with Lomustine “medac” will probably include bone marrow toxicity, haematological toxicity, abdominal pain, nausea and vomiting, diarrhoea, anorexia, lethargy, dizziness, abnormal hepatic function, cough, and shortness of breath.
Overdose should be treated immediately by gastric lavage.
There is no specific antidote to overdose with Lomustine “medac”. Treatment should be symptomatic and supportive. Appropriate blood product replacement should be given as clinically required.
Shelf life: 3 years as packaged for sale.
Do not store above 25°C.
Store in the original container in order to protect from light and moisture.
Securitainers containing 20 capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements..
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