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CARMUSTINE FOR is a brand name for Carmustine, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Carmustine for Injection USP is indicated as palliative therapy to surgery and radiotherapy as a single agent or in established combination therapy with other chemotherapeutic agents in the following: Brain tumours - glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumours. Multiple myeloma - in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients with impaired renal function. Pediatric and Geriatric patients. In patients with Combination/Concomitant therapy with other myelosuppressive drugs or in whom the bone marrow reserves are depleted.
2 Recommended Dose and Dosage Adjustment The recommended dose of Carmustine for Injection USP as a single agent in previously untreated patients is 200 mg/m² intravenously every 6 weeks. This may be given as a single dose or divided into daily injections such as 100 mg/m² on 2 successive days.
A repeat course of Carmustine for Injection USP should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000 cells/mm³, leukocytes above 4,000 cells/mm³) and this usually occurs within six weeks.
Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed hematologic toxicity. Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose, in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products.
The following schedule is suggested as a guide to dosage adjustment:
Table 1 Nadir After Prior Dose Percentage of Prior Dose to be GivenLeukocytes Platelets > 4000 > 100,000 100% 3000 - 3999 75,000 - 99,999 100% Serious Warnings and Precautions Carmustine for Injection USP should only be used by physicians with special experience in the field of chemotherapy.
Carmustine for Injection USP can cause common serious side effects such as o Severe bone marrow depression or Myelosupression o Hepatic toxicity o Severe (end-stage) Renal impairment Complete blood count, Hepatic and Renal function tests are checked prior to treatment and regularly monitored during therapy.
Carmustine for Injection USP should be used with extreme caution in children (<18 years of age) due to high risk of pulmonary toxicity. g. g. platelets < 25,000 then a maximum of 50% of prior dose should be given). Patients with impaired renal function In patients with impaired renal function, the dose of carmustine should be reduced depending on the glomerular filtration rate.
Geriatrics (65 years of age) In general, dose selection for an elderly patient should be cautious, usually starting at the lo w end of the dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and take into consideration concomitant disease or other therapy with other medicinal products.
). 3 Reconstitution Preparation of Intravenous Solutions To facilitate reconstitution, allow the powder vial and supplied sterile diluent (Dehydrated Alcohol Injection USP) to come to controlled room temperature (15°C to 30°C) before mixing.
Dissolve Carmustine for Injection USP (100 mg powder) completely with 3 mL of the supplied sterile diluent and dilute to 30 mL by aseptically adding 27 mL of Sterile Water for Injection to the alcohol solution. 8). Carmustine must be completely dissolved in ethanol before sterile water for injection is added.
Reconstitution as recommended results in a clear, colorless to yellowish solution that can be stored in a refrigerator (2°C-8°C) for 48 hours. The infusion solution concentrate must be checked for precipitations before use. If precipitates have formed, they can be dissolved again by warming the vial to room temperature with gentle shaking.
To prepare the ready-to-use infusion, the infusion solution concentrate (30 mL) is to be diluted immediately with 500 mL of Sodium Chloride for Injection or 5% Dextrose for Injection. e. the ready-to-use solution) should be mixed for at least 10 seconds before administration.
The ready-to-use infusion should be used within 8 hours and protected from light. e. glass or polypropylene containers. 4 Administration The reconstituted solution should be used intravenously only and should be administered by slow IV infusion over a 1- to 2-hour period, protected from light.
Rapid IV infusion in less than one hour may produce intense pain and burning at the site of injection (see 8 ADVERSE REACTIONS). The lyophilized dosage formulation contains no preservatives and is not intended as a multipl e dose vial.
The ready-to-use infusion can be stored in the refrigerator (2°C-8°C) for 24 hours and, protected from light, for an additional 6 hours at room temperature (15°C - 25°C). (For more information see 11 STORAGE, STABILITY AND DISPOSAL).
Carmustine should only be used by physicians with special experience in the field of chemotherapy. General Parenteral administration The intra-arterial compatibility has not been tested. Severe tissue damage can be expected i n case of inadvertent intra-arterial administration.
Experimental direct injection of Carmustine to the carotid artery has been associated with ocular toxicity. During administration of carmustine, administration site reactions may occur. Given the possibility of extravasation, close monitoring of the infusion site is recommended for possible infiltration during administration.
A special method for handling extravasation is currently unknown. Accidental contact of the reconstituted infusion solution with the skin has resulte d in burns and excessive pigmentation in the affected areas. Local soft tissue toxicity resulting from extravasation of carmustine has been reported.
Infiltration of carmustine may cause swelling, pain, erythema, burning, and skin necrosis. This is especially important for elderly patients. Carcinogenesis and Mutagenesis Carmustine is carcinogenic in rats and mice, producing a marked increase in tumor incidence in doses approximating those employed clinically.
The benefit to the mother versus the risk of toxicity to the mother and fetus must be carefully weighed. See 16 NON-CLINICAL TOXICOLOGY for discussion on animal data. Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed, however, it should be taken into account that the amount of alcohol in this medicinal product may affect the Carmustine for Injection USP Page 9 of 30 ability to drive and use machines.
Hematologic Bone marrow toxicity Delayed and cumulative 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 Recommended Dose and Dosage Adjustment).
Patients who are hypersensitive to Carmustine for Injection USP (carmustine), to other nitrosoureas or to any excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 2 Breastfeeding). Carmustine for Injection USP Page 5 of 30
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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As elderly patients are more likely to have decreased renal function, care should be taken in selecting the dose, monitoring renal function, and reducing the dose accordingly. Pediatrics (<18 years of age) Carmustine is contraindicated (see 2 CONTRAINDICATIONS) due to the high risk of pulmonary toxicity (see 8 ADVERSE REACTIONS).
3 Reconstitution Preparation of Intravenous Solutions To facilitate reconstitution, allow the powder vial and supplied sterile diluent (Dehydrated Alcohol Injection USP) to come to controlled room temperature (15°C to 30°C) before mixing.
Dissolve Carmustine for Injection USP (100 mg powder) completely with 3 mL of the supplied sterile diluent and dilute to 30 mL by aseptically adding 27 mL of Sterile Water for Injection to the alcohol solution. 8). Carmustine must be completely dissolved in ethanol before sterile water for injection is added.
Reconstitution as recommended results in a clear, colorless to yellowish solution that can be stored in a refrigerator (2°C-8°C) for 48 hours. The infusion solution concentrate must be checked for precipitations before use. If precipitates have formed, they can be dissolved again by warming the vial to room temperature with gentle shaking.
To prepare the ready-to-use infusion, the infusion solution concentrate (30 mL) is to be diluted immediately with 500 mL of Sodium Chloride for Injection or 5% Dextrose for Injection. e. the ready-to-use solution) should be mixed for at least 10 seconds before administration.
The ready-to-use infusion should be used within 8 hours and protected from light. e. glass or polypropylene containers. 4 Administration The reconstituted solution should be used intravenously only and should be administered by slow IV infusion over a 1- to 2-hour period, protected from light.
Rapid IV infusion in less than one hour may produce intense pain and burning at the site of injection (see 8 ADVERSE REACTIONS). The lyophilized dosage formulation contains no preservatives and is not intended as a multipl e dose vial.
The ready-to-use infusion can be stored in the refrigerator (2°C-8°C) for 24 hours and, protected from light, for an additional 6 hours at room temperature (15°C - 25°C). (For more information see 11 STORAGE, STABILITY AND DISPOSAL).
5 Missed Dose Not applicable.
5 Missed Dose Not applicable. 5 OVERDOSAGE In the case of overdosage, the patient should be treated symptomatically. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3- Dosage Forms, Strengths, Composition and Packaging: For management of a suspected drug overdose, contact your regional poison control centre.
Carmustine for Injection USP Page 8 of 30 Route of Administration Dosage Form/ Strength/Composition Non-medicinal Ingredients Intravenous (iv) Lyophilized powder, 100 mg/vial Powder - no excipients Sterile Diluent - Dehydrated Alcohol Injection USP Carmustine for Injection USP is available in a package that includes a 30 mL amber glass vial with a rubber (not made with natural rubber latex) stopper containing 100 mg of carmustine (powder) and a glass vial with a rubber (not made with natural rubber latex) stopper containing 3 mL of sterile diluent.
7 WARNINGS AND PRECAUTIONS Carmustine should only be used by physicians with special experience in the field of chemotherapy. General Parenteral administration The intra-arterial compatibility has not been tested. Severe tissue damage can be expected i n case of inadvertent intra-arterial administration.
Experimental direct injection of Carmustine to the carotid artery has been associated with ocular toxicity. During administration of carmustine, administration site reactions may occur. Given the possibility of extravasation, close monitoring of the infusion site is recommended for possible infiltration during administration.
A special method for handling extravasation is currently unknown. Accidental contact of the reconstituted infusion solution with the skin has resulte d in burns and excessive pigmentation in the affected areas. Local soft tissue toxicity resulting from extravasation of carmustine has been reported.
Infiltration of carmustine may cause swelling, pain, erythema, burning, and skin necrosis. This is especially important for elderly patients. Carcinogenesis and Mutagenesis Carmustine is carcinogenic in rats and mice, producing a marked increase in tumor incidence in doses approximating those employed clinically.
The benefit to the mother versus the risk of toxicity to the mother and fetus must be carefully weighed. See 16 NON-CLINICAL TOXICOLOGY for discussion on animal data. Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed, however, it should be taken into account that the amount of alcohol in this medicinal product may affect the Carmustine for Injection USP Page 9 of 30 ability to drive and use machines.
Hematologic Bone marrow toxicity Delayed and cumulative 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 Recommended Dose and Dosage Adjustment).
In addition to this, the liver, kidney and lung function should be examined and monitored regularly during the carmustine therapy. Repeat doses of Carmustine should not be given more frequently than every six weeks. The myelosuppression is dose and cumulative dose related, and often biphasic.
Thrombocytopenia is generally more pronounced than […]
In addition to this, the liver, kidney and lung function should be examined and monitored regularly during the carmustine therapy. Repeat doses of Carmustine should not be given more frequently than every six weeks. The myelosuppression is dose and cumulative dose related, and often biphasic.
Thrombocytopenia is generally more pronounced than leukopenia, but both are dose -limiting adverse effects. Anaemia is common but is usually less pronounced. 2 Recommended Dose and Dosage Adjustment). Respiratory Lung toxicity has been observed in up to 30% of patients.
The early onset of lung toxicity (within 3 years of treatment) resulted in pulmonary infiltrates and / or pulmonary fibrosis, some of which were fatal. The patients were between 22 months and 72 years old. The risk f actors include smoking, respiratory diseases, existing radiographic abnormalities, sequential or simultaneous chest irradiation and the combination with other active substances that can cause lung damage.
The incidence of side effects is likely to be dose dependent. Cumulative doses of 1200-1500 mg / m2 have been associated with an increased likelihood of pulmonary fibrosis. Spirometry (FVC, DLCO) should be performed regularly during treatment.
Patients who have a baseline value of <70% of the expected forced expiratory vital capacity (FVC) or the carbon monoxide diffusion capacity (DLCO) are particularly at risk. Cases of very late onset pulmonary fibrosis (up to 17 years after treatment) have been observed in patients who received carmustine in childhood or adolescence.
Long-term follow-up of 17 patients who survived childhood brain tumors showed that 8 of them died of pulmonary fibrosis. Two of these 8 deaths occurred within the first 3 years of treatment and 6 within 8-13 years of treatment. 5 years (1-12 years) and the mean age of the long-term survivors was 10 years (5-16 years).
All patients younger than 5 years at the time of treatment died of pulmonary Carmustine for Injection USP Page 10 of 30 fibrosis. Neither the carmustine dose nor the addition of vincristine or irradiation to the spine had any effect on the fatal outcome.
Pulmonary fibrosis was noted in all remaining survivors who were available for follow -up. The risk- benefit ratio of carmustine therapy must be carefully considered due to the high risk of lung toxicity. Hepatic/Biliary/Pancreatic Hepatic necrosis may occur after administration of doses higher than those recommended in the dosage instructions.
Monitoring and Laboratory Tests In addition to Complete Blood Count, hepatic, and renal should also be checked prior to treatment and regularly monitored during therapy (see