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Carmustine Medac (Previously Carmustine Obvius) is a brand name for Carmustine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Carmustine is indicated in adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery): - Brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases -…
Verbatim from this product's EMA label. Tap a section to expand.
Carmustine medac must be administered only by specialists experienced in the field of chemotherapy and under appropriate medical supervision 3 Posology Initial doses The recommended dose of Carmustine medac as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks.
This may be given as a single dose or divided into daily infusions such as 75 to 100 mg/m2 on two successive days. When Carmustine medac is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should be adjusted according to the haematologic profile of the patient as shown below.
Monitoring and subsequent doses A repeat course of Carmustine medac should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks.
Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed haematologic toxicity. Doses subsequent to the initial dose should be adjusted according to the haematologic response of the patient to the preceding dose, in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products.
g. g. platelets <25,000 then a maximum of 50% of prior dose should be given). There are no limits for the period of application of carmustine therapy. In case the tumor remains incurable or some serious or intolerable adverse reactions appear, the carmustine therapy must be terminated.
Conditioning treatment prior to HPCT Carmustine is given in combination with other chemotherapeutic agents in patients with malignant haematological diseases before HPCT at a dose of 300 – 600 mg/m2 intravenously. 3) Elderly In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and take into consideration concomitant disease or therapy with other medicinal products.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and the glomerular filtration rate should be monitored and the dose reduced according to this. 4 Renal impairment For patients with renal impairment, the dose of Carmustine medac should be reduced if the glomerular filtration rate is reduced.
Summary of the safety profile The table includes adverse reactions that were presented during treatment with this medicinal product but may not necessarily have a causal relationship with the medicinal product. Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed may not reflect the rates observed in clinical practice.
Adverse reactions are generally included if they were reported in more than 1% of patients in the product monograph or pivotal trials, and/or determined to be clinically important. When placebo-controlled trials are available, adverse reactions are included if the incidence is ≥ 5% higher in the treatment group.
Tabulated list of adverse reactions The following table includes adverse reactions of carmustine listed by MedDRA system organ class and frequency convention presented in order of decreasing seriousness: 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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. MedDRA system organ class Frequency Adverse reactions Infections and infestations Not known Opportunistic infections (including fatal) Neoplasms benign, malignant and unspecified (including cysts and polyps) Common Acute leukaemia, bone marrow dysplasia – following long-term use.
Blood and lymphatic system disorders 7 Very common Myelosuppression. Common Anaemia. Nervous system disorders Very common Ataxia, dizziness, headache. Common Encephalopathy (high-dose therapy and dose-limiting). Not known Muscular pain, status epilepticus, seizure, grand mal seizure.
Eye disorders Very common Ocular toxicities, transient conjunctival flushing and blurred vision due to retinal haemorrhages. Cardiac disorders Very common Hypotension, due to the alcohol content of the solvent (high-dose therapy). Not known Tachycardia Vascular disorders Very common Phlebitis.
Pulmonary toxicity characterised by pulmonary infiltrates and/or fibrosis has been reported to occur with a frequency ranging up to 30%. This may occur within 3 years of therapy and appears to be dose related with cumulative doses of 1,200-1,500 mg/m2 being associated with increased likelihood of lung fibrosis.
Risk factors include smoking, the presence of a respiratory condition, pre-existing radiographic abnormalities, sequential or concomitant thoracic irradiation and association with other agents that cause lung damage. Baseline pulmonary function studies and chest X-ray 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. An increased risk for pulmonary toxicities upon treatment with conditioning regimes and HPCT for females has been reported.
g. TBI or busulfan-cyclophosphamide) or with carmustine (BEAM: carmustine, etopside, cytarabine and melphalan or CBV: cyclophosphamide, carmustine and etoposide). High-dose therapy with carmustine (especially with 600 mg/m2) prior to haematopoietic stem cell transplantation has been shown to increase the risk for incidence and severity of pulmonary toxicities.
Therefore, in patients with other risks for pulmonary toxicities, use of carmustine needs to be weighed against the risks. Upon high-dose therapy with carmustine, the risk and severity for infections, cardiac, hepatic, gastrointestinal, and renal toxicity, diseases of the nervous system and electrolyte abnormalities (hypokalemia, hypomagnesemia and hypophosphatemia) rises.
5 Patients with comorbidities and worse disease status have a higher risk for adverse reactions. This needs to be respected especially for elderly patients. 8). Neutropenic enterocolitis can occur as therapy-related adverse reaction upon treatment with chemotherapeutic agents.
1. - Severe bone marrow depression. - Severe (end-stage) renal impairment. - Children and adolescents - Breast-feeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Method of administration Carmustine medac is for intravenous use after reconstitution and further dilution. By reconstituting the powder with the solvent provided, a solution has to be prepared by adding additional 27 ml water for injections.
9%) solution for injection, or glucose 50 mg/ml (5%) solution for injection. The resulting ready-to-use solution for infusion should then be administered immediately by intravenous drip over a one- to two-hour period protected from light.
The duration of infusion should not be less than one hour, otherwise it leads to burning and pain in the injected area. The injected area should be monitored during the administration. 6.
Rare Veno-occlusive disease (high-dose therapy). Respiratory, thoracic and mediastinal disorders Very common Pulmonary toxicity, interstitial fibrosis (with prolonged therapy and cumulative dose)* Pneumonitis. Rare Interstitial fibrosis (with lower doses).
Gastrointestinal disorders Very common Emetogenic potential. Nausea and vomiting – severe Common Anorexia, constipation, diarrhoea, stomatitis. Hepatobiliary disorders Common Hepatotoxicity, reversible, delayed up to 60 days after administration (high-dose therapy and dose-limiting), manifested by: - bilirubin, reversible increase - alkaline phosphatase, reversible increase - SGOT, reversible increase.
Skin and subcutaneous tissue disorders Very common Dermatitis with topical use improves with reduced concentration of compounded product, hyperpigmentation, transient, with accidental skin contact. 8 Common Alopecia, flushing (due to alcohol content of solvent; increased with administration times <1-2 h), injection site reaction.
Not known Extravasation hazard: vesicant Renal and urinary disorders Rare Renal toxicity. Reproductive system and breast disorders Rare Gynecomastia. Not known Infertility, teratogenesis. Metabolism and nutrition disorders Not known Electrolyte abnormalities (hypokalemia, hypomagnesemia and hypophosphatemia) * An increased risk for pulmonary toxicities upon treatment with conditioning regimes and HPCT for females has been reported.
g. TBI or busulfan-cyclophosphamide) or with carmustine (BEAM: carmustine, etopside, cytarabine and melphalan or CBV: cyclophosphamide, carmustine and etoposide). Description of selected adverse reactions Myelosuppression Myelosuppression is very common and begins 7-14 days of administration with recovery 42-56 days of administration.
The myelosuppression is dose and cumulative dose related, and often biphasic. Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis (with fatal outcome), pulmonary infiltration Pulmonary toxicity has been observed in up to 30% of patients.
In cases where pulmonary toxicity started early (within 3 years of treatment), pulmonary infiltrates and/or pulmonary fibrosis occurred, some of which were fatal. The patients were between 22 months and 72 years old. Risk factors include smoking, respiratory disease, existing radiographic abnormalities, sequential or concomitant thoracic radiation, as well as combination with other active substances that can cause lung damage.
The incidence of adverse reactions is probably dose-related; cumulative doses of 1200-1500 mg/m2 have been associated with an increased likelihood of pulmonary fibrosis. During treatment, lung function tests (FVC, DLCO) should be performed regularly.
Patients showing a baseline value of <70% of expected forced vital capacity or carbon monoxide diffusion capacity in these tests are at particular risk. In patients having received carmustine in childhood or adolescence, cases of extremely delayed-onset pulmonary fibrosis (up to 17 years after treatment) have been described.
Long-term follow-up observation of 17 patients who survived brain tumours in childhood showed that 8 of them succumbed to pulmonary fibrosis. Two of these 8 fatalities occurred within the first 3 years of treatment and 6 of them occurred 8-13 years after treatment.
5 years (1-12 years), the median age of long-term survivors on treatment was 10 years (5-16 years). All patients younger than 5 years of age at the time of treatment died from pulmonary fibrosis; neither the carmustine dose nor an additional vincristine dose or spinal radiation had any influence on the fatal outcome.
All remaining survivors available for follow-up were diagnosed with pulmonary fibrosis. Use of carmustine in children and adolescents < 18 years is contraindicated, see […]
3). Bone marrow toxicity is a common and severe toxic adverse reaction of carmustine. Complete blood count should be monitored frequently for at least six weeks after a dose. 2. 8). Repeat doses of Carmustine medac should not be given more frequently than every six weeks.
2). Direct administration of carmustine into the carotid artery is regarded as experimental and has been associated with ocular toxicity. 7 mg/100 ml. For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.
g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects. Because this medicine is usually given slowly over 6 hours, the effects of alcohol may be reduced.