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BICNU 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: BiCNU (carmustine ) 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 combination…
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 BiCNU 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 BiCNU 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.
g. g. platelets <25,000 then a maximum of 50% of prior dose should be given). BiCNU Page 6 of 39 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 low 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.
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 Carmustine for Injection (powder) with propylene glycol diluent: Preparation of Intravenous Solutions Dissolve carmustine (100 mg powder) with 3 mL of the supplied sterile diluent (propylene glycol injection) until clear solution is achieved.
). 3 Reconstitution Carmustine for Injection (powder) with propylene glycol diluent: Preparation of Intravenous Solutions Dissolve carmustine (100 mg powder) with 3 mL of the supplied sterile diluent (propylene glycol injection) until clear solution is achieved.
If required, stir vigorously to get clear solution. Use the propylene glycol vial for reconstitution after achieving the room temperature only and use the larger bore size needle (less than 22-gauge needle) to remove the diluent from the vial.
3 mg of carmustine. Reconstitution, as recommended, results in a yellowish solution. 9% Sodium chloride injection or 5% dextrose injection. 2 mg/mL of Carmustine which must be stored protected from light. Examine reconstituted vials for crystal formation prior to use.
If crystals are observed, they may be re- dissolved by warming the vial to room temperature with agitation. Reconstituted vials should be inspected visually for particulate matter and discoloration prior to administration. After reconstitution and dilution After reconstitution as recommended, the reconstituted solution is stable for 480 hours under refrigeration (2°C -8°C) and 24 hours at temperature (25°C ±2°C) in glass container.
Examine reconstituted vials for crystal formation prior to use. The reconstituted diluted solution should be used within 8 hours at 25°C ± 2°C and protected from light. BiCNU Page 7 of 39 The reconstituted diluted solution can be stored in the refrigerator (2-8° C) for 48 hours and, protected from light, for an additional 6 hours at temperature (25°C ± 2°C).
2 mg/mL of Carmustine Carmustine for Injection (Solution): The medicinal product contains no preservative and is not intended as multiple dose vial. The dilutions should be carried out under aseptic conditions. Dilution for each vial for solution for infusion Use the vial after achieving the room temperature only and the vial solution should be present in clear liquid form before usage.
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 in 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 infusion solution with the skin has resulted 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. Comorbidities and poor disease status Patients with comorbidities and poorer disease status are at higher risk for adverse events. This is especially important for elderly patients.
Carcinogenesis and Mutagenesis Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous (iv) use after dilution Solution for Infusion, 100 mg/mL Polysorbate 80 BiCNU Page 10 of 39 BiCNU 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, there is a possibility of dizziness as an adverse reaction reported with this medicinal product which may affect the ability to drive and use machines.
• Carmustine for Injection (powder) is contraindicated in patients who are hypersensitive to BiCNU (carmustine), to other nitrosoureas or to any excipients. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Carmustine for Injection (Solution) is contraindicated in patients who are hypersensitive to BiCNU (carmustine), polysorbate 80, other nitrosoureas or to any of any excipient. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Breastfeeding).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Carmustine in Canada.
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If required, stir vigorously to get clear solution. Use the propylene glycol vial for reconstitution after achieving the room temperature only and use the larger bore size needle (less than 22-gauge needle) to remove the diluent from the vial.
3 mg of carmustine. Reconstitution, as recommended, results in a yellowish solution. 9% Sodium chloride injection or 5% dextrose injection. 2 mg/mL of Carmustine which must be stored protected from light. Examine reconstituted vials for crystal formation prior to use.
If crystals are observed, they may be re- dissolved by warming the vial to room temperature with agitation. Reconstituted vials should be inspected visually for particulate matter and discoloration prior to administration. After reconstitution and dilution After reconstitution as recommended, the reconstituted solution is stable for 480 hours under refrigeration (2°C -8°C) and 24 hours at temperature (25°C ±2°C) in glass container.
Examine reconstituted vials for crystal formation prior to use. The reconstituted diluted solution should be used within 8 hours at 25°C ± 2°C and protected from light. BiCNU Page 7 of 39 The reconstituted diluted solution can be stored in the refrigerator (2-8° C) for 48 hours and, protected from light, for an additional 6 hours at temperature (25°C ± 2°C).
2 mg/mL of Carmustine Carmustine for Injection (Solution): The medicinal product contains no preservative and is not intended as multiple dose vial. The dilutions should be carried out under aseptic conditions. Dilution for each vial for solution for infusion Use the vial after achieving the room temperature only and the vial solution should be present in clear liquid form before usage.
Use the larger bore size needle (below 22-gauge needle) to remove the solution from the vial. Each mL of the vial solution contains 100 mg of carmustine. 9% Sodium chloride injection or 5% dextrose injection. 2 mg/mL of Carmustine which must be stored protected from light.
Examine the vials for presence of clear liquid prior to use. If crystals are observed, they may be re-dissolved by warming the vial to room temperature with agitation. The ready-to-use solution should be administered over 1-2 hours, protected from light.
Administration should be finalised within 3 hours from dilution of the medicinal product. 4 Administration). Administration of the infusion should be performed using a PVC free PE infusion set. Guidelines for the safe handling and disposal of antineoplastic agents must be observed.
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Use the larger bore size needle (below 22-gauge needle) to remove the solution from the vial. Each mL of the vial solution contains 100 mg of carmustine. 9% Sodium chloride injection or 5% dextrose injection. 2 mg/mL of Carmustine which must be stored protected from light.
Examine the vials for presence of clear liquid prior to use. If crystals are observed, they may be re-dissolved by warming the vial to room temperature with agitation. The ready-to-use solution should be administered over 1-2 hours, protected from light.
Administration should be finalised within 3 hours from dilution of the medicinal product. 4 Administration). Administration of the infusion should be performed using a PVC free PE infusion set. Guidelines for the safe handling and disposal of antineoplastic agents must be observed.
4 Administration Carmustine for Injection (powder) with propylene glycol diluent: BiCNU Page 8 of 39 The reconstituted diluted 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 multiple dose vial.
The reconstituted diluted solution in glass or polypropylene containers can be stored in the refrigerator (2-8°C) for 48 hours and, protected from light, for an additional 6 hours at temperature (25°C ± 2°C). (For more information See 11 STORAGE, STABILITY AND DISPOSAL) The solution for infusion is unstable in polyvinyl chloride (PVC) containers.
The carmustine solution can be administered from glass bottles or polypropylene container only, using PVC-free infusion set.
Carmustine for Injection (Solution):
For intravenous use after dilution. 9%) solution for injection, or dextrose 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. The solution for infusion is unstable in polyvinyl chloride (PVC) containers.
The carmustine solution can be administered from glass bottles or polypropylene container only, using PVC-free infusion set. 5 Missed Dose Not applicable. 5 OVERDOSAGE In the case of overdosage, the patient should be treated symptomatically.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 3– Dosage Forms, Strengths, Composition and Packaging: Carmustine for Injection (powder) with propylene glycol diluent: Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous (iv) Powder, 100 mg/vial Powder – no excipients Sterile Diluent- Propylene glycol BiCNU Page 9 of 39 BiCNU (carmustine for Injection, USP; DIN: 00297763) is available in a package that includes a 30 mL amber glass vial with butyl rubber (not made with natural […]
Carmustine for Injection contains propylene glycol which mimics the similar effects of alcohol in the medicinal product. 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 to 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 factors 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.
BiCNU Page 11 of 39 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 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