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Carmustine (Gliadel): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
100 mg/30 mL
Brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Carmustine

INSTRUCTIONS FOR USE OF COMBI KIT GUARD FOR

Carmustine for Injection, USP

About Combi Kit Guard

  • This Combi Kit Guard is specially designed for your safety.
  • Please do not remove the vials from the Combi Kit Guard.
  • Keep the Combi Kit Guard in a carton till the time of use.

How to use this Combi Kit Guard

The instructions below explain how to use this Combi Kit Guard

The Combi Kit Guard has two compartments. One holds the 100 mg carmustine vial and the other holds the 3 mL sterile diluent (Dehydrated Alcohol Injection, USP) vial.

List of items required: gloves, alcohol swabs, sterile syringe.

Wear gloves at all times when handling COMBI KIT Guard.

Discard the COMBI KIT Guard after use.

Step 1

Take out COMBI KIT Guard from carton & place on the table

Step 2

Remove the Flip seals from both the vials by holding the vial in Combi Guard.

Step 3

Aseptically remove 3 mL sterile diluent from the vial with the help of sterile syringe.

Step 4

Inject the sterile diluent into vial containing 100 mg carmustine.

Step 5

Hold the COMBI KIT guard by hand firmly and gently shake to dissolve the content.

Step 6

Aseptically add 27 mL Sterile Water for Injection USP.

Step 7

Hold the COMBI KIT guard by hand firmly and shake gently.

Step 8

Aseptically remove the diluted product and infuse after further dilution as recommended with Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.

Please refer the product information leaflet before administration.

For more information call

Sandoz Inc. at 1-800-525-8747

Manufactured by:

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Lianyungang, Jiangsu 222047, China

Manufactured for:

Sandoz Inc., Princeton, NJ 08540

1-800-525-8747

Rev. 08/2021

20AUF02

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 211202 · View the label on DailyMed

Revision date stated in the text: August 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Carmustine

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Alkylating Drug
Active ingredient Carmustine 100 mg/30 mL
Dosage form Kit
Marketing status listed in the FDA NDC Directory
Company (applicant) HENGRUI PHARMA
FDA approval ANDA 211202Abbreviated New Drug Application (ANDA) – generic drug Approved March 12, 2021
Manufacturers 12 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg/30 mL – 1 in 1 carton NDC 0781-3474-32

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.