(doxorubicin hydrochloride)

Prescribing Information
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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling.

•
Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1)]
•
Secondary Malignancies [see Warnings and Precautions (5.2)]
•
Extravasation and Tissue Necrosis [see Warnings and Precautions (5.3)]
•
Severe Myelosuppression [see Warnings and Precautions (5.4)]
•
Tumor Lysis Syndrome [see Warnings and Precautions (5.6)]
•
Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.7)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Breast Cancer

The safety data below were collected from 1492 women who received doxorubicin hydrochloride at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 2. No treatment-related deaths were reported in patients on either arm of the study.

Table 2. Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes
Adverse ReactionsAC*
N = 1492		Conventional CMF
N = 739
%%
AC = doxorubicin hydrochloride, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil
*
Includes pooled data from patients who received either AC for 4 cycles or AC for 4 cycles followed by CMF for 3 cycles

Alopecia

92

71

Vomiting

     Vomiting ≤12 hours

34

25

     Vomiting >12 hours

37

12

     Intractable

5

2

Leukopenia

     Grade 3 (1,000–1,999 /mm3)

3.4

9.4

     Grade 4 (<1000 /mm3)

0.3

0.3

Shock, sepsis

2

1

Systemic infection

2

1

Cardiac dysfunction

     Asymptomatic

0.2

0.1

     Transient

0.1

0

     Symptomatic

0.1

0

Thrombocytopenia

     Grade 3 (25,000–49,999 /mm3)

0

0.3

     Grade 4 (<25,000 /mm3)

0.1

0

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Doxorubicin Hydrochloride Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac – Cardiogenic shock

Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia

Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa

Hypersensitivity – Anaphylaxis

Laboratory Abnormalities – Increased ALT, increased AST

Neurological – Peripheral sensory and motor neuropathy, seizures, coma

Ocular – Conjunctivitis, keratitis, lacrimation

Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism

Other – Malaise/asthenia, fever, chills, weight gain

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:

•
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:
o
have other heart problems
o
have had or are currently receiving radiation therapy to your chest
o
have had treatment with certain other anti-cancer medicines
o
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:

o
extreme tiredness or weakness
o
shortness of breath
o
fast heartbeat
o
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.

•
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.
•
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.
•
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.
•
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:

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

•
have heart problems including heart failure.
•
are currently receiving radiation therapy or plan to receive radiation to the chest.
•
have liver problems.
•
have had an allergic reaction to doxorubicin.
•
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:
o
Your healthcare provider will check to see if you are pregnant before you start treatment with Doxorubicin.
o
You should use effective birth control (contraception) during treatment with Doxorubicin and for 6 months after treatment.
 
Males:
o
Doxorubicin can affect your sperm and could cause birth defects.
o
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.
o
If you have a pregnant partner, you should use condoms during treatment with Doxorubicin and for at least 10 days after the final dose.
o
Talk to your healthcare provider about birth control methods that may be right for you.
•
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?

•
Doxorubicin will be given to you into your vein through an intravenous (IV) line.
•
Your healthcare provider will do blood tests to check for side effects during treatment with Doxorubicin.
•
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:

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

The most common side effects of Doxorubicin include:

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

Other side effects:

•
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.
•
Call your healthcare provider if you have severe symptoms that prevent you from eating or drinking, such as:
o
nausea
o
vomiting
o
diarrhea
o
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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