"The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.
Biological products are generally derived from a living organism. They can come from many sources, in"...
BiCNU (carmustine) is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:
- Brain tumors - glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
- Multiple myeloma - in combination with prednisone.
- 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.
- 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.
DOSAGE AND ADMINISTRATION
The recommended dose of BiCNU (carmustine) as a single agent in previously untreated patients is 150 to 200 mg/m 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 (carmustine) 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|
A repeat course of BiCNU (carmustine) 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.
As with other potentially toxic compounds, caution should be exercised in handling BiCNU (carmustine) and preparing the solution of BiCNU (carmustine) . Accidental contact of reconstituted BiCNU (carmustine) with the skin has caused transient hyperpigmentation of the affected areas. The use of gloves is recommended. If BiCNU (carmustine) lyophilized material or solution contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.
The reconstituted solution should be used intravenously only and should be administered by IV drip. Injection of BiCNU (carmustine) over shorter periods of time than 1 to 2 hours may produce intense pain and burning at the site of injection.
Preparation of Intravenous Solutions
First, dissolve BiCNU (carmustine) 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 (carmustine) 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.
The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose vial.
The 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 (59°-86°F, 15°-30°C) or in a refrigerator (2°-8°C, 36°-46°F). The recommended storage of unopened BiCNU (carmustine) vials provides a stable product for up to 3 years. After reconstitution as recommended, BiCNU (carmustine) 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 (carmustine) administration.
BiCNU (carmustine) 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 (carmustine) will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the BiCNU (carmustine) is suitable for use and should be refrigerated immediately.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published 1-8. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing BiCNU (carmustine) . This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.
BiCNU® (carmustine for injection). Each package includes a vial containing 100 mg carmustine and an ampule containing 3 mL sterile diluent.
Store in a refrigerator (2°-8°C, 36°-46°F).
Store diluent at controlled room temperature (59°-86°F, 15°-30°C) or in a refrigerator (2°-8°C, 36°-46°F).
1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999:32-41.
2. Recommendations for the safe handling of cytotoxic drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992. US Dept of Health and Human Services, Public Health Service Publication NIH 92-2621.
3. AMA Council on Scientific Affairs. Guidelines for handling parenteral antineoplastics. JAMA. 1985;253:1590-1592.
4. National Study Commission on Cytotoxic Exposure. Recommendations for handling cytotoxic agents. 1987. Available from Louis P. Jeffrey, ScD, Chairman, National Study Commission on Cytotoxic Exposure. Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.
5. Clinical Oncological Society of Australia. Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. 1983;1:426-428.
6. Jones RB, Frank R, Mass T. Safe handling of chemotherapeutic agents: a report from The Mount Sinai Medical Center. CA Cancer J Clin. 1983;33:258-263.
7. American Society of Hospital Pharmacists. ASHP technical assistance bulletin on handling cytotoxic and hazardous drugs. Am JHosp Pharm. 1990;47:1033-1049.
8. Controlling occupational exposure to hazardous drugs. (OSHA Work-Practice Guidelines.) Am J Health-Syst Pharm. 1996;53:1669-1685.
BiCNU (carmustine) manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146. Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. RevAugust 2007This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/13/2016
Additional BiCNU Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get the latest treatment options.