(doxorubicin hydrochloride)

Prescribing Information
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2 DOSAGE AND ADMINISTRATION

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adjuvant Breast Cancer

The recommended dosage of Doxorubicin Hydrochloride Injection is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles.

2.2 Recommended Dosage for Other Cancers

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The recommended dosage of Doxorubicin Hydrochloride Injection when used as a single agent is 60 mg/m2 to 75 mg/m2 intravenously every 21 days.
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The recommended dosage of Doxorubicin Hydrochloride Injection, when administered in combination with other chemotherapy drugs, is 40 mg/m2 to 75 mg/m2 intravenously every 21 to 28 days.
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Consider use of the lower Doxorubicin Hydrochloride Injection dose in the recommended dosage range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
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Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)].

2.3 Dosage Modifications for Adverse Reactions

Cardiomyopathy

Discontinue Doxorubicin Hydrochloride Injection in patients who develop signs or symptoms of cardiomyopathy [see Warnings and Precautions (5.1)].

2.4 Dosage Modifications for Hepatic Impairment

Doxorubicin Hydrochloride Injection is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin greater than 5 mg/dL) [see Contraindications (4)].

Dosage modifications for Doxorubicin Hydrochloride Injection in patients with elevated serum total bilirubin concentrations [see Warnings and Precautions (5.5), Use in Specific Populations (8.6)] are provided in Table 1.

Table 1. Recommended Dosage Modification for Elevated Serum Total Bilirubin
Serum Total Bilirubin ConcentrationDosage Modification

1.2–3 mg/dL

50%

3.1–5 mg/dL

75%

Greater than 5 mg/dL

Do not initiate Doxorubicin Hydrochloride Injection;
discontinue Doxorubicin Hydrochloride Injection

2.5 Preparation and Administration

Doxorubicin Hydrochloride Injection is a hazardous drug. Follow applicable special handling and disposal procedures.1

Preparation

Dilution of Doxorubicin Hydrochloride Injection

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Dilute Doxorubicin Hydrochloride Injection in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP.
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Protect from light following preparation until completion of infusion.
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Use within 1 hour. If not used within 1 hour, discard the diluted product.

Administration

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Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

Administration by Intravenous Injection

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Administer diluted Doxorubicin Hydrochloride Injection as an intravenous injection through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
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Administer intravenously over 3 to 10 minutes. Decrease the rate of infusion if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

Administration by Continuous Intravenous Infusion

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Administer diluted Doxorubicin Hydrochloride Injection solution only through a central intravenous line. Decrease the rate of infusion if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.
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Protect from light from preparation for infusion until completion of infusion.

Management of Suspected Extravasation

Immediately discontinue Doxorubicin Hydrochloride Injection for burning or stinging sensation or other evidence indicating peri-venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

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Do not remove the needle until attempts are made to aspirate extravasated fluid.
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Do not flush the line.
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Avoid applying pressure to the site.
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Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days.
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If the extravasation is in an extremity, elevate the extremity.
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In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)].

Management of Contact with Skin or Eyes

Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

Incompatibility with Other Drugs

Do not admix Doxorubicin Hydrochloride Injection with other drugs. If Doxorubicin Hydrochloride Injection is mixed with heparin or fluorouracil, a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin hydrochloride.

Medication Guide

MEDICATION GUIDE

Patient Information

DOXORUBICIN (dok-suh-roo-buh-sin) HYDROCHLORIDE
injection, for intravenous use

What is the most important information I should know about Doxorubicin?

Doxorubicin may cause serious side effects including:

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Heart muscle problems. Doxorubicin can cause heart muscle damage that may lead to heart failure. Heart failure means your heart does not pump blood well. Heart failure is irreversible in some cases and can lead to death. Heart failure can happen during your treatment with Doxorubicin or months to years after stopping treatment. Your risk of heart muscle damage increases with higher total amounts of Doxorubicin that you receive in your lifetime. Your risk of heart failure is higher if you:
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have other heart problems
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have had or are currently receiving radiation therapy to your chest
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have had treatment with certain other anti-cancer medicines
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take other medicines that can have severe side effects on your heart

Tell your healthcare provider if you get any of these symptoms of heart failure during or after treatment with Doxorubicin:

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extreme tiredness or weakness
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shortness of breath
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fast heartbeat
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swelling of your feet and ankles

Your healthcare provider will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin.

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Heart rhythm problems. Doxorubicin can cause serious heart rhythm problems that may lead to death. This can happen during your infusion, within a few hours after your infusion or anytime during treatment with Doxorubicin. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast, irregular or slow, or you feel lightheaded, dizzy, short of breath, chest discomfort or you faint.
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Risk of new cancers. You may have an increased risk of developing certain blood cancers called acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) after treatment with Doxorubicin. Talk with your healthcare provider about your risk of developing new cancers if you receive Doxorubicin.
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Skin damage at or near the vein where Doxorubicin is given. Doxorubicin can damage the skin if it leaks out of the vein and might cause blisters, skin sores or severe tissue damage, which may require skin grafts. Tell your healthcare provider if you get burning or stinging during your infusion.
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Decreased blood cell counts. Doxorubicin can cause a decrease in neutrophils (a type of white blood cell important in fighting bacterial infections) and platelets (important for clotting and to control bleeding). This may lead to a serious infection, the need for blood transfusions, treatment in a hospital or death. Your healthcare provider will check your blood cell counts before each infusion and during treatment with Doxorubicin. Call your healthcare provider right away if you get a fever (temperature of 100.4°F or higher) or chills with shivering.

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:

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you have had a recent heart attack (within the past 4 to 6 weeks) or have severe heart problems.
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your blood cell counts (platelets, red blood cells, and white blood cells) are very low because of prior chemotherapy.
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you have severe liver problems.
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you have had a severe allergic reaction to Doxorubicin.

Before you receive Doxorubicin, tell your healthcare provider about all of your medical conditions, including if you:

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have heart problems including heart failure.
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are currently receiving radiation therapy or plan to receive radiation to the chest.
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have liver problems.
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have had an allergic reaction to doxorubicin.
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are pregnant or plan to become pregnant. Doxorubicin can harm your unborn baby. You should not become pregnant during treatment with Doxorubicin. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
Females who are able to become pregnant:
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Your healthcare provider will check to see if you are pregnant before you start treatment with Doxorubicin.
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You should use effective birth control (contraception) during treatment with Doxorubicin and for 6 months after treatment.
 
Males:
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Doxorubicin can affect your sperm and could cause birth defects.
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If you have a female partner who can become pregnant, you should use effective birth control during treatment with Doxorubicin and for 3 months after treatment.
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If you have a pregnant partner, you should use condoms during treatment with Doxorubicin and for at least 10 days after the final dose.
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Talk to your healthcare provider about birth control methods that may be right for you.
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are breastfeeding or plan to breastfeed. Doxorubicin can pass into your breast milk. Do not breastfeed during treatment with Doxorubicin and for 10 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

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?

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Doxorubicin will be given to you into your vein through an intravenous (IV) line.
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Your healthcare provider will do blood tests to check for side effects during treatment with Doxorubicin.
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Your healthcare provider may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Doxorubicin.

What are the possible side effects of Doxorubicin?

Doxorubicin may cause serious side effects, including:

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See “What is the most important information I should know about Doxorubicin?”

The most common side effects of Doxorubicin include:

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total hair loss (alopecia). Your hair may re-grow after your treatment.
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nausea
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vomiting

Other side effects:

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Red colored urine. You may have red colored urine for 1 to 2 days after your infusion of Doxorubicin. This is normal. Tell your healthcare provider if it does not stop in a few days, or if you see what looks like blood or blood clots in your urine.
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Call your healthcare provider if you have severe symptoms that prevent you from eating or drinking, such as:
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nausea
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vomiting
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diarrhea
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mouth pain or sores

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.


Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

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.

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This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 7/2024

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