DOXORUBICIN Patient Counseling Information

(doxorubicin hydrochloride)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Cardiomyopathy

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions (5.1)].

Secondary Malignancy

Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions (5.2)].

Myelosuppression

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions (5.4)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].

Advise patients that Doxorubicin Hydrochloride Injection/for Injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 3 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Advise males with pregnant partners to use condoms during treatment with Doxorubicin Hydrochloride Injection/for Injection and for at least 10 days after the final dose [see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 10 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of the potential loss of fertility from Doxorubicin Hydrochloride Injection/for Injection [see Use in Specific Populations (8.3)].

Gastrointestinal and Dermatologic Adverse Reactions

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking [see Adverse Reactions (6)]. Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause alopecia [see Adverse Reactions (6.1)].

Administration

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause their urine to appear red for 1 to 2 days after administration.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Cardiomyopathy

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions (5.1)].

Secondary Malignancy

Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions (5.2)].

Myelosuppression

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions (5.4)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].

Advise patients that Doxorubicin Hydrochloride Injection/for Injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 3 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Advise males with pregnant partners to use condoms during treatment with Doxorubicin Hydrochloride Injection/for Injection and for at least 10 days after the final dose [see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 10 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of the potential loss of fertility from Doxorubicin Hydrochloride Injection/for Injection [see Use in Specific Populations (8.3)].

Gastrointestinal and Dermatologic Adverse Reactions

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking [see Adverse Reactions (6)]. Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause alopecia [see Adverse Reactions (6.1)].

Administration

Advise patients that Doxorubicin Hydrochloride Injection/for Injection can cause their urine to appear red for 1 to 2 days after administration.

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