Bicnu
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Questions & Answers
Side Effects & Adverse Reactions
Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of BiCNU should not be given more frequently than every 6 weeks.
The bone marrow toxicity of BiCNU is cumulative; therefore, dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see "Dosage Adjustment Table" under DOSAGE AND ADMINISTRATION).
Pulmonary toxicity from BiCNU appears to be dose related. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less. Additionally delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients who received BiCNU in childhood and early adolescence (see ADVERSE REACTIONS).
Long-term use of nitrosoureas has been reported to be associated with the development of secondary malignancies.
Liver and renal function tests should be monitored periodically (see ADVERSE REACTIONS).
BiCNU (carmustine for injection) may cause fetal harm when administered to a pregnant woman. BiCNU has been shown to be embryotoxic in rats and rabbits and teratogenic in rats when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
BiCNU has been administered through an intraarterial intracarotid route; this procedure is investigational and has been associated with ocular toxicity.
Injection site reactions may occur during the administration of BiCNU (see ADVERSE REACTIONS: Other Toxicities). Given the possibility of extravasation, close monitoring of the infusion site for possible infiltration during drug administration is recommended. A specific treatment for extravasation reactions is unknown at this time.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
BiCNU (carmustine for injection) is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
1. Brain tumors- glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
2. Multiple myeloma-in combination with prednisone.
3. Hodgkin's disease-as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
4. Non-Hodgkin's lymphomas- as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
History
There is currently no drug history available for this drug.
Other Information
BiCNU® (carmustine for injection) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1,3-bis(2-chloroethyl)-1-nitrosourea. It is sterile lyophilized pale yellow flakes or congealed mass with a molecular weight of 214.06. It is highly soluble in alcohol and lipids, and poorly soluble in water. BiCNU is administered by intravenous infusion after reconstitution as recommended.
The structural formula is:
BiCNU is available in 100-mg single dose vials of lyophilized material. Sterile diluent for constitution of BiCNU is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP.
Sources
Bicnu Manufacturers
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Heritage Pharmaceuticals Inc.
![Bicnu (Carmustine) Kit [Heritage Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bicnu | Heritage Pharmaceuticals Inc.
The recommended dose of BiCNU 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 injections such as 75 to 100 mg/m2 on 2 successive days. When BiCNU is used in combination with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted, the doses should be adjusted accordingly.
Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:
Nadir After Prior Dose
Percentage of Prior Dose to
be Given
Leukocytes/mm3
Platelets/mm3
>4000
>100,000
100%
3000-3999
75,000-99,999
100%
2000-2999
25,000-74,999
70%
<2000
<25,000
50%
A repeat course of BiCNU 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 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative.Administration Precautions
As with other potentially toxic compounds, caution should be exercised in handling BiCNU and preparing the solution of BiCNU. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 Accidental contact of reconstituted BiCNU with the skin has caused transient hyperpigmentation of the affected areas. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing BiCNU. If BiCNU lyophilized material or solution contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. More information is available in the references listed below.Reconstituted solution should only be administered by slow intravenous infusion. Administration of BiCNU over a period of less than 2 hours can lead to pain and burning at the site of injection.
Preparation of Intravenous Solutions
First, dissolve BiCNU with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP). Second, aseptically add 27 mL Sterile Water for Injection, USP. Each mL of resulting solution contains 3.3 mg of BiCNU in 10% ethanol. Such solutions should be protected from light.Reconstitution as recommended results in a clear, colorless to yellowish solution which may be further diluted with 5% Dextrose Injection, USP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Important Note
The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.Stability
The unopened vial of the dry drug must be stored in a refrigerator (2°-8°C, 36°-46°F). The diluent vials must be stored in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years. After reconstitution as recommended, BiCNU is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F). Reconstituted vials should be examined for crystal formation prior to use. If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation.Vials reconstituted as directed and further diluted to a concentration of 0.2 mg/mL in 5% Dextrose Injection, USP, should be stored at room temperature, protected from light and utilized within 8 hours.
Glass containers were used for the stability data provided in this section. Only use glass containers for BiCNU administration.Important Note
BiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass.If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.
-
E.r. Squibb & Sons, L.l.c.
Bicnu | E.r. Squibb & Sons, L.l.c.
The recommended dose of BiCNU 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 injections such as 75 to 100 mg/m2 on 2 successive days. When BiCNU is used in combination with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted, the doses should be adjusted accordingly.
Doses subsequent to the initial dose should be adjusted according to the hematologic response of the patient to the preceding dose. The following schedule is suggested as a guide to dosage adjustment:
Nadir After Prior Dose Percentage of Prior Dose to
be Given Leukocytes/mm3 Platelets/mm3 >4000 >100,000 100% 3000–3999 75,000–99,999 100% 2000–2999 25,000–74,999 70% <2000 <25,000 50%A repeat course of BiCNU 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 6 weeks. Adequate number of neutrophils should be present on a peripheral blood smear. Blood counts should be monitored weekly and repeat courses should not be given before 6 weeks because the hematologic toxicity is delayed and cumulative.
Administration PrecautionsAs with other potentially toxic compounds, caution should be exercised in handling BiCNU and preparing the solution of BiCNU. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–4 Accidental contact of reconstituted BiCNU with the skin has caused transient hyperpigmentation of the affected areas. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing BiCNU. If BiCNU lyophilized material or solution contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water. More information is available in the references listed below.
Reconstituted solution should only be administered by slow intravenous infusion. Administration of BiCNU over a period of less than 2 hours can lead to pain and burning at the site of injection.
Preparation of Intravenous SolutionsFirst, dissolve BiCNU with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP). Second, aseptically add 27 mL Sterile Water for Injection, USP. Each mL of resulting solution contains 3.3 mg of BiCNU in 10% ethanol. Such solutions should be protected from light.
Reconstitution as recommended results in a clear, colorless to yellowish solution which may be further diluted with 5% Dextrose Injection, USP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Important NoteThe lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.
StabilityThe unopened vial of the dry drug must be stored in a refrigerator (2°-8°C, 36°-46°F). The diluent ampules may be stored at controlled room temperature (15°-30°C, 59°-86°F) or in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU vials provides a stable product for up to 3 years. After reconstitution as recommended, BiCNU is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F). Reconstituted vials should be examined for crystal formation prior to use. If crystals are observed, they may be redissolved by warming the vial to room temperature with agitation.
Vials reconstituted as directed and further diluted to a concentration of 0.2 mg/mL in 5% Dextrose Injection, USP, should be stored at room temperature, protected from light and utilized within 8 hours.
Glass containers were used for the stability data provided in this section. Only use glass containers for BiCNU administration.
Important NoteBiCNU has a low melting point (30.5°-32.0°C or 86.9°-89.6°F). Exposure of the drug to this temperature or above will cause the drug to liquefy and appear as an oil film on the vials. This is a sign of decomposition and vials should be discarded. If there is a question of adequate refrigeration upon receipt of this product, immediately inspect the vial in each individual carton. Hold the vial to a bright light for inspection. The BiCNU will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU is suitable for use and should be refrigerated immediately.
![Bicnu (Carmustine) Kit [E.r. Squibb & Sons, L.l.c.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be6776fe-7f24-417d-ef08-8830c4eca959&name=bicnu-100mglabel.jpg)
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