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LOMUSTINE MEDAC is a brand name for Lomustine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As palliative or supplementary treatment, usually in combination with radiotherapy and/or surgery as part of multiple drug regimens in: - brain tumours (primary or metastatic) - lung tumours (especially oat-cell carcinoma) Hodgkin’s disease (resistant to conventional combination chemotherapy) - malignant melanoma…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Lomustine "medac" is given by mouth. g. 40 mg/m²/day). Dosage is reduced - if Lomustine "medac" is given as part of a drug regimen which includes other marrow-depressant medicinal products. - in the presence of leucopenia below 3,000/mm³ or thrombocytopenia below 75,000/mm³.
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.
Paediatric population 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).
Method of administration Lomustine "medac" is given by mouth. The capsules should not be opened and should be swallowed whole.
Summary of the safety profile Bone marrow toxicity and gastrointestinal symptoms are the most frequent and relevant undesirable effects of lomustine. Tabulated list of adverse reactions The list is presented by system organ class and frequency, using the following categories: • Very common (≥1/10) • Common (≥1/100 to <1/10) • Uncommon (≥1/1,000 to <1/100) • Rare (≥1/10,000 to <1/1,000) • Very rare (<1/10,000) • Not known (cannot be estimated from the available data).
System Organ Class Frequency MedDRA Term Common InfectionInfections and infestations Not known Herpes zoster Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Very rare Second primary malignancy, acute leukaemia, myelodysplastic syndrome Blood and lymphatic system disorders Very common Myelosuppression, pancytopenia, thrombocytopenia, leukopenia, neutropenia, anaemia Immune system disorders Common Immunosuppression Common Coordination abnormal, disorientation, lethargy, dysarthria, ataxia Nervous system disorders Uncommon Apathy, confusional state, dysphemia Eye disorders Very rare After combined therapy with radiation: blindness Respiratory, thoracic and mediastinal disorders Rare Interstitial lung disease, System Organ Class Frequency MedDRA Term pulmonary fibrosis, dyspnoea, cough Not known Lung infiltration Very common Nausea, vomiting, decreased appetite Common Stomatitis, diarrhoea Gastrointestinal disorders Common Hepatic function abnormal Hepatobiliary disorders Rare Jaundice cholestatic, hepatic failure Skin and subcutaneous tissue disorders Rare Alopecia, rash, pruritus Uncommon Renal failure, renal injury Renal and urinary disorders Not known Azotaemia, renal atrophy Reproductive system and breast disorders Rare Spermatogenesis abnormal, ovulation disorder General disorders and administration site conditions Common Pyrexia, chills, swelling (especially feet and lower legs) Common Hepatic enzymes increased (ASAT, ALAT, LDH and alkaline phosphatase) Investigations Not known Blood bilirubin increased Description of selected adverse reactions Blood and lymphatic system disorders The most frequent and most serious toxicity of lomustine is delayed or prolonged myelosuppression.
Patients receiving lomustine chemotherapy should be under the care of physicians experienced in cancer treatment. 8). Delayed bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of lomustine.
Treatment and dosage are governed principally by the haemoglobin, white cell count and platelet count. At the recommended dose, courses of lomustine must not be given more frequently than every 6 weeks. 2). The bone marrow toxicity of lomustine is cumulative and therefore dose adjustment must be considered on the basis of nadir blood counts from prior dose.
8). Baseline pulmonary function studies should be conducted along with frequent pulmonary function tests during treatment. Patients with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DLco) are particularly at risk.
8). Renal function tests should also be assessed periodically. 8). Long term use of nitrosoureas has been reported to be possibly associated with the development of secondary malignancies. Care must be taken whenever handling anticancer products.
Steps should be taken to avoid exposure. This includes the use of appropriate equipment, such as wearing gloves, and washing hands with soap and water after handling such products. It is recommended that patients do not receive live vaccines until at least 3 months after the end of treatment with lomustine.
Excipients Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Wheat starch This medicine contains only very low levels of gluten (from wheat starch).
It is regarded as ‘gluten-free’ and is very unlikely to cause problems in patients with coeliac disease. One capsule contains no more than 4 micrograms of gluten. Patients with wheat allergy must not take this medicine.
5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It usually occurs 4 to 6 weeks after administration of the medicinal product and is dose related. Thrombocytopenia occurs at about 4 weeks post-administration and lasts 1 or 2 weeks at a level around 80 - 100,000/mm³. Leukopenia occurs 5 to 6 weeks after a dose of lomustine and persists for 1 to 2 weeks.
Approximately 65 % of patients receiving 130 mg/m² develop white blood cell counts below 5,000 WBC/mm³. Thirty-six percent develop white blood cell counts below 3,000/mm³. Thrombocytopenia is generally more severe than leukopenia. However, both may be dose-limiting toxicities.
Lomustine may produce cumulative myelosuppression, manifested by more depressed indices or longer duration of suppression after repeated doses. Anaemia also occurs but is less frequent and less severe than thrombocytopenia or leukopenia.
The occurrence of acute leukaemia and bone marrow dysplasia has been reported in patients following long term nitrosourea therapy. Respiratory, thoracic and mediastinal disorders Pulmonary toxicity characterised by pulmonary infiltrates, interstitial pneumonia and/or fibrosis has been rarely reported with lomustine.
Onset of toxicity has occurred after an interval of 6 months or longer from the start of therapy with cumulative doses of lomustine usually greater than 1,100 mg/m². There is one report of pulmonary toxicity at a cumulative dose of only 600 mg/m².
Delayed pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients with intracranial tumours who received related nitrosoureas during their childhood and early adolescence. Gastrointestinal disorders Nausea and vomiting may occur 3 to 6 hours after an oral dose and usually last for less than 24 hours, followed by anorexia for 2 to 3 days.
The effects are less troublesome if the 6-weekly dose is divided into three doses and given on the first 3 days of each 6-week period. The frequency and duration may be reduced by the use of antiemetics prior to dosing and by the administration of lomustine to fasting patients.
Hepatobiliary disorders A reversible type of hepatic toxicity, manifested by increased transaminase, alkaline phosphatase, and bilirubin levels, has been reported in a small percentage of patients receiving lomustine. An effect on liver function manifested by transient elevation of liver enzymes (ASAT, ALAT, LDH and alkaline phosphatase) is commonly observed.
In the majority of cases, this is mild. Cholestatic jaundice has been reported in rare cases. Renal and urinary disorders Renal abnormalities consisting of decrease in kidney size, progressive azotaemia, and renal failure have been reported in patients who receive large cumulative doses after prolonged therapy with lomustine and related nitrosoureas.
The cumulative dose in these cases was higher than 1,500 mg/m². Kidney damage has also been reported occasionally in patients receiving lower total doses. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.