May 29, 2017
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Bicnu

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BiCNU




Indications
Dosage
How Supplied

INDICATIONS

BiCNU® (carmustine for injection) is indicated as palliative therapy as a single agent or in established combination therapy in the following:

DOSAGE AND ADMINISTRATION

Dosage

The recommended dose of BiCNU as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks. Administer as a single dose or divided into daily injections such as 75 to 100 mg/m2 on two successive days. Lower the dose when BiCNU is used with other myelosuppressive drugs or in patients in whom bone marrow reserve is depleted. Administer BiCNU for the duration according to the established regimen. Premedicate each dose with anti-emetics.

Adjust doses subsequent to the initial dose 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 tobe 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%

The hematologic toxicity can be delayed and cumulative. Monitor blood counts weekly. Do not administer a repeat course of BiCNU until circulating blood elements have returned to acceptable levels (platelets above 100 Gi/L, leukocytes above 4 Gi/L and absolute neutrophil count above 1 Gi/L). The usual interval between courses is 6 weeks.

Evaluate renal function prior to administration and periodically during treatment. For patients with compromised renal function, monitor for toxicity more frequently. Discontinue BiCNU if the creatinine clearance is less than 10 mL/min. Do not administer BiCNU to patients with compromised renal function. Monitor transaminases and bilirubin periodically during treatment. [see ADVERSE REACTIONS.

Preparation And Administration Of Intravenous Solution

  • Dissolve BiCNU with 3 mL of the supplied sterile diluent (Dehydrated Alcohol Injection, USP).
  • 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.
    • The reconstituted solution is a clear, colorless to yellowish solution.
  • Once reconstituted, the solution must be further diluted with Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
    • 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.
    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
    • After reconstitution as recommended, BiCNU is stable for 24 hours under refrigeration (2°-8°C, 36°-46°F) in glass container. Examine reconstituted vials 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 with 500 mL Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, in glass or polypropylene containers to a concentration of 0.2 mg/mL, should be stored at room temperature, protected from light and utilized within 8 hours. These solutions are also stable 24 hours under refrigeration (2°-8°C, 36°-46°F) and an additional 6 hours at room temperature protected from light.
  • Administer reconstituted solution by slow intravenous infusion over at least two hours. Administration of BiCNU over a period of less than two hours can lead to pain and burning at the site of injection. Monitor the injected area during the administration. The rate of administration of the intravenous infusion should not be more than 1.66 mg/m2/min
  • See Section 16.2 for important instructions on the storage and handling of the injection. BiCNU is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
  • The lyophilized dosage formulation contains no preservatives and is not intended for use as a multiple dose via.

Accidental contact of reconstituted BiCNU with the skin has caused transient hyperpigmentation of the affected areas. Wear impervious gloves to minimize the risk of dermal exposure impervious gloves when handling vials containing BiCNU. Immediately wash the skin or mucosa thoroughly with soap and water if BiCNU lyophilized material or solution contacts the skin or mucosa1 .

HOW SUPPLIED

Dosage Forms And Strengths

For injection: 100 mg of carmustine as a lyophilized powder in a single-dose vial for reconstitution and a vial containing 3 mL sterile diluent (Dehydrated Alcohol Injection, USP).

Storage And Handling

BiCNU® (carmustine for injection). Each package includes a vial containing 100 mg carmustine and a vial containing 3 mL sterile diluent.

NDC 23155-261-41

Store product and diluent in a refrigerator (2°-8°C, 36°-46°F).

Stability

Store the unopened vial of the dry drug in a refrigerator (2°-8°C, 36°-46°F). Store the diluent vials 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.

Compatibility/ Incompatibility With Containers

The intravenous solution is unstable in polyvinyl chloride container. DO NOT USE PVC Containers. Administer BiCNU solution from the glass bottles or polypropylene container only. Ensure the polypropylene containers used are PVC free and DEHP free.

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.

REFERENCES

1.“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

Manufactured by: Emcure Pharmaceuticals Ltd.,Hinjawadi, Pune, India. Revised: March 2017.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/11/2017

Indications
Dosage
How Supplied

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.


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