Carmustine (Page 4 of 5)

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 by:
Amneal Oncology Pvt. Ltd.

Telangana 509301, INDIA

Distributed by:
Amneal Biosciences LLCBridgewater, NJ 08807

Rev. 10-2018-01

Instructions For Use

Carmustine (kar musĀ“ teen) for Injection, USP

Instructions for use of Combi Kit Guard for Carmustine for Injection

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.

Procedures

Steps

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

1
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Remove the Flip seals from both the vials by holding the vial in Combi Guard.

2
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Aseptically remove 3 mL sterile diluent from the vial with the help of sterile syringe.

3
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Inject the sterile diluent into vial containing 100 mg carmustine.

4
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Hold the COMBI KIT guard by hand firmly and gently shake to dissolve the content.

5
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Aseptically add 27 mL Sterile Water for Injection USP.

6
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Hold the COMBI KIT guard by hand firmly and shake gently.

7
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Aseptically remove the diluted product and infuse after further dilution as recommended with Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.

8
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Please refer the product information leaflet before administration.

For more information, go to www.amneal.com or call toll-free 1-855-266-3251.

Manufactured by:
Amneal Oncology Pvt. Ltd.

Telangana 509301, INDIA

Distributed by:
Amneal Biosciences LLCBridgewater, NJ 08807

Rev. 10-2018-01

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