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DOXIL- doxorubicin hydrochloride injection, suspension, liposomal


Patient Information

Cardiomyopathy

Advise patients to contact their healthcare provider if they develop symptoms of heart failure[seeWarnings and Precautions (5.1)].

Infusion-Related Reactions

Advise patients about the symptoms of infusion-related reactions and to seek immediate medical attention if they develop any of these symptoms[seeWarnings and Precautions (5.2)].

Myelosuppression

Advise patients to contact their healthcare provider for a new onset fever or symptoms of infection.

Hand-Foot Syndrome

Advise patients to notify their healthcare provider if they experience tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (symptoms of Hand-Foot Syndrome)[seeWarnings and Precautions (5.3)].

Stomatitis

Advise patients to notify their healthcare provider if they develop painful redness, swelling, or sores in the mouth (symptoms of stomatitis).

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy[seeWarnings and Precautions (5.5)andUse in Specific Populations (8.1)].

Advise females and males of reproductive potential to use effective contraception during and for 6 months following treatment with DOXIL[seeUse in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with DOXIL[seeUse in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that DOXIL may cause temporary or permanent infertility[seeUse in Specific Populations (8.3)].

Discoloration of Urine and Body Fluids

Inform patients that following DOXIL administration, a reddish-orange color to the urine and other body fluids may be observed. This nontoxic reaction is due to the color of the product and will dissipate as the drug is eliminated from the body.

Manufactured by:
TTY Biopharm Company Limited
Taoyuan City, 32069, Taiwan

or

GlaxoSmithKline Manufacturing S.p.A.
Parma, Italy

Manufactured for:
Janssen Products, LP
Horsham, PA 19044
Janssen Products, LP 2010

An Alza Corporation STEALTHTechnology Product.

STEALTHand DOXILare registered trademarks of Alza Corporation.



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