Carmustine (Page 4 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carmustine is carcinogenic in rats and mice, producing a marked increase in tumor incidence in doses approximating those employed clinically. Nitrosourea therapy does have carcinogenic potential in humans [see Adverse Reactions (6.1)] .

Carmustine was mutagenic and clastogenic in multiple in vitro and in vivo genetic toxicology studies.

Male rats treated with carmustine at cumulative doses ≥ 36 mg/kg (216 mg/ m 2), approximately 0.15 times the maximum cumulative human dose on a mg/ m 2 basis, showed decreases in reproductive potential when mated with untreated female rats (e.g., decreased implantations, increased resorption rate, and a decrease in viable fetuses).

15 REFERENCES

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

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Carmustine for injection, USP. Each package includes a vial containing 100 mg carmustine and a vial containing 3 mL sterile diluent.

NDC 54879-036-64

16.2 Storage and Handling

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 Carmustine for Injection, USP vials provides a stable product for up to 2 years.

Compatibility/ Incompatibility with Containers

The intravenous solution is unstable in polyvinyl chloride container. DO NOT USE PVC Containers.

Administer Carmustine for Injection, USP solution from the glass bottles or polypropylene container only. Ensure the polypropylene containers used are PVC free and DEHP free.

Important Note

Carmustine for Injection, USP 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 Carmustine for Injection, USP will appear as a very small amount of dry flakes or dry congealed mass. If this is evident, the Carmustine for Injection, USP is suitable for use and should be refrigerated immediately.

17 PATIENT COUNSELING INFORMATION

Myelosuppression [see Warnings and Precautions (5.1)].

A serious and frequent toxicity of Carmustine for Injection is delayed myelosuppression and usually occurs 4 to 6 weeks after drug administration. Hence, patients should be advised to get blood counts monitored weekly for at least 6 weeks. The bone marrow toxicity of Carmustine for Injection is cumulative.

Pulmonary Toxicity [see Warnings and Precautions (5.2)].

Advise patients to contact a health care professional immediately for any of the following: shortness of breath, particularly during exercise, dry, hacking cough, fast, shallow breathing, gradual unintended weight loss, tiredness, aching joints and muscles, clubbing (widening and rounding) of the tips of the fingers or toes.

Seizures [see Adverse Reactions (6)]

Inform the patient that they may suffer from fits and advise them to get medical attention immediately in such cases.

Pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations ( 8.1 and 8.3)]

Advise pregnant women and females of reproductive potential that Carmustine for Injection exposure during pregnancy can result in fetal harm. Advise female patients to contact their healthcare provider with a known or suspected pregnancy. Advise women of reproductive potential to avoid becoming pregnant. Advise females of reproductive potential to use effective contraception during treatment.

Lactation [see Use in Specific Populations (8.2)]

Advise the female patient to discontinue nursing while taking Carmustine for Injection.

Manufactured in Germany For:

STI Pharma LLC
Newtown, PA 18940,
1.888.301.9680

Rev: 12/18

ifupg1
(click image for full-size original)
ifupg2
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — diluent label

NDC 54879- 024 -13

Rx only

Dehydrated Alcohol Injection, USP

3 mL

Sterile Diluent for Carmustine for injection, USP

Diluent Label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — vial label

NDC 54879- 023 -51

Carmustine for injection, USP

100 mg per vial

For intravenous infusion after reconstitution

REFRIGERATE IMMEDIATELY

Single Dose Vial — Discard Unused Portion

Carmustine Label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — carton

DC 54879- 036 -64

Rx only

Carmustine for injection, USP

100 mg per vial

Each carton contains: 1 vial carmustine for injection 100 mg, 1 vial Sterile Diluent for carmustine for injection 3 mL

For intravenous infusion after reconstitution

REFRIGERATE IMMEDIATELY

Single Dose Vial – Discard Unused Portion

Carton Label
(click image for full-size original)

CARMUSTINE
carmustine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54879-036
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54879-036-64 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 30 mL
Part 2 1 VIAL 3 mL
Part 1 of 2
CARMUSTINE
carmsutine injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:54879-023
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARMUSTINE (CARMUSTINE) CARMUSTINE 100 mg in 30 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54879-023-51 30 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209278 05/16/2019
Part 2 of 2
ALCOHOL
alcohol injection, solution
Product Information
Item Code (Source) NDC:54879-024
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 3 mL in 3 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54879-024-13 3 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209278 05/16/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209278 05/16/2019
Labeler — STI Pharma LLC (832714070)
Registrant — STI Pharma LLC (832714070)

Revised: 09/2019 STI Pharma LLC

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