Advise the patient to read the FDA-approved patient labeling (Patient Information).
Cardiomyopathy
Advise patients that Doxorubicin Hydrochloride 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 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 and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].
Advise patients that Doxorubicin Hydrochloride 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 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 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 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 [see Use in Specific Populations (8.3)].
Gastrointestinal and Dermatologic Adverse Reactions
Advise patients that Doxorubicin Hydrochloride 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 can cause alopecia [see Adverse Reactions (6.1)].
Patient Information | |||
DOXORUBICIN (dok-suh-roo-buh-sin) HYDROCHLORIDE | |||
What is the most important information I should know about Doxorubicin? | |||
Doxorubicin may cause serious side effects including:
| |||
|
| ||
Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin. | |||
| |||
What is Doxorubicin? | |||
Doxorubicin is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines. | |||
Do not receive Doxorubicin if:
| |||
Before you receive Doxorubicin, tell your healthcare provider about all of your medical conditions, including if you:
| |||
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||
How will I receive Doxorubicin?
| |||
What are the possible side effects of Doxorubicin? | |||
Doxorubicin may cause serious side effects, including: | |||
The most common side effects of Doxorubicin include:
| |||
Other side effects:
| |||
Doxorubicin may cause fertility problems in males. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. | |||
Doxorubicin may cause fertility problems in females. Your periods (menstrual cycle) may completely stop when you receive Doxorubicin. Your periods may or may not return following treatment. Early menopause has also happened. Talk to your healthcare provider if this is a concern for you. | |||
These are not all of the possible side effects of Doxorubicin. | |||
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
General information about the safe and effective use of Doxorubicin. | |||
| |||
You can ask your pharmacist or healthcare provider for information about Doxorubicin that is written for health professionals. | |||
What are the ingredients in Doxorubicin? | |||
Active ingredient: doxorubicin hydrochloride | |||
Inactive ingredients for Doxorubicin Hydrochloride Injection: sodium chloride, and hydrochloric acid, USP. | |||
LAB-0436-5.0 | |||
| |||
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 7/2024 |
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Cardiomyopathy
Advise patients that Doxorubicin Hydrochloride 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 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 and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].
Advise patients that Doxorubicin Hydrochloride 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 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 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 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 [see Use in Specific Populations (8.3)].
Gastrointestinal and Dermatologic Adverse Reactions
Advise patients that Doxorubicin Hydrochloride 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 can cause alopecia [see Adverse Reactions (6.1)].
Patient Information | |||
DOXORUBICIN (dok-suh-roo-buh-sin) HYDROCHLORIDE | |||
What is the most important information I should know about Doxorubicin? | |||
Doxorubicin may cause serious side effects including:
| |||
|
| ||
Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin. | |||
| |||
What is Doxorubicin? | |||
Doxorubicin is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines. | |||
Do not receive Doxorubicin if:
| |||
Before you receive Doxorubicin, tell your healthcare provider about all of your medical conditions, including if you:
| |||
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||
How will I receive Doxorubicin?
| |||
What are the possible side effects of Doxorubicin? | |||
Doxorubicin may cause serious side effects, including: | |||
The most common side effects of Doxorubicin include:
| |||
Other side effects:
| |||
Doxorubicin may cause fertility problems in males. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. | |||
Doxorubicin may cause fertility problems in females. Your periods (menstrual cycle) may completely stop when you receive Doxorubicin. Your periods may or may not return following treatment. Early menopause has also happened. Talk to your healthcare provider if this is a concern for you. | |||
These are not all of the possible side effects of Doxorubicin. | |||
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
General information about the safe and effective use of Doxorubicin. | |||
| |||
You can ask your pharmacist or healthcare provider for information about Doxorubicin that is written for health professionals. | |||
What are the ingredients in Doxorubicin? | |||
Active ingredient: doxorubicin hydrochloride | |||
Inactive ingredients for Doxorubicin Hydrochloride Injection: sodium chloride, and hydrochloric acid, USP. | |||
LAB-0436-5.0 | |||
| |||
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 7/2024 |
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Cardiomyopathy
Advise patients that Doxorubicin Hydrochloride 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 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 and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].
Advise patients that Doxorubicin Hydrochloride 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 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 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 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 [see Use in Specific Populations (8.3)].
Gastrointestinal and Dermatologic Adverse Reactions
Advise patients that Doxorubicin Hydrochloride 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 can cause alopecia [see Adverse Reactions (6.1)].
Patient Information | |||
DOXORUBICIN (dok-suh-roo-buh-sin) HYDROCHLORIDE | |||
What is the most important information I should know about Doxorubicin? | |||
Doxorubicin may cause serious side effects including:
| |||
|
| ||
Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin. | |||
| |||
What is Doxorubicin? | |||
Doxorubicin is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines. | |||
Do not receive Doxorubicin if:
| |||
Before you receive Doxorubicin, tell your healthcare provider about all of your medical conditions, including if you:
| |||
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. | |||
How will I receive Doxorubicin?
| |||
What are the possible side effects of Doxorubicin? | |||
Doxorubicin may cause serious side effects, including: | |||
The most common side effects of Doxorubicin include:
| |||
Other side effects:
| |||
Doxorubicin may cause fertility problems in males. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. | |||
Doxorubicin may cause fertility problems in females. Your periods (menstrual cycle) may completely stop when you receive Doxorubicin. Your periods may or may not return following treatment. Early menopause has also happened. Talk to your healthcare provider if this is a concern for you. | |||
These are not all of the possible side effects of Doxorubicin. | |||
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||
General information about the safe and effective use of Doxorubicin. | |||
| |||
You can ask your pharmacist or healthcare provider for information about Doxorubicin that is written for health professionals. | |||
What are the ingredients in Doxorubicin? | |||
Active ingredient: doxorubicin hydrochloride | |||
Inactive ingredients for Doxorubicin Hydrochloride Injection: sodium chloride, and hydrochloric acid, USP. | |||
LAB-0436-5.0 | |||
| |||
This Patient Information has been approved by the U.S. Food and Drug Administration. | Revised: 7/2024 |
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