DOXORUBICIN Contraindications (doxorubicin hydrochloride) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:

Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
Recent (occurring within the past 4–6 weeks) myocardial infarction [see Warnings and Precautions (5.1)]
Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4)]
Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5)]
Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2)]

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION

Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur...

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1 INDICATIONS AND USAGE

1.1 Adjuvant Breast Cancer

Doxorubicin Hydrochloride Injection/for Injection is indicated as a component of multi-agent adjuvant chemotherapy...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adjuvant Breast Cancer

The recommended dosage of Doxorubicin Hydrochloride Injection/for Injection is 60 mg/m...

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3 DOSAGE FORMS AND STRENGTHS

Doxorubicin Hydrochloride Injection:
- 10 mg/5 mL, 20 mg/10 mL and 50 mg/25 mL (2 mg/mL) clear red solution in a single-dose vial
- 150 mg/75 mL and 200 mg/...

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4 CONTRAINDICATIONS

Doxorubicin Hydrochloride Injection/for Injection are contraindicated in patients with:

Severe myocardial insufficiency [see Warnings and...

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5 WARNINGS AND PRECAUTIONS

5.1 Cardiomyopathy and Arrhythmias

Cardiomyopathy

...

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6 ADVERSE REACTIONS

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

Cardiomyopathy and Arrhythmias [see Warnings...

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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on Doxorubicin Hydrochloride Injection/for Injection

...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in...

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10 OVERDOSAGE

Few cases of overdose have been described.

A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m2) in one day. He...

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11 DESCRIPTION

Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor isolated from cultures of Streptomyces peucetius var. caesius. The chemical name...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The cytotoxic effect of doxorubicin hydrochloride on malignant cells and its toxic effects on various organs are...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxorubicin hydrochloride treatment can increase the risk of secondary...

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14 CLINICAL STUDIES

14.1 Adjuvant Breast Cancer

The efficacy of doxorubicin hydrochloride-containing regimens for the post-operative, adjuvant treatment of surgically...

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15 REFERENCES

"Hazardous Drugs". OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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16 HOW SUPPLIED/STORAGE AND HANDLING

Doxorubicin Hydrochloride Injection

Doxorubicin Hydrochloride Injection is a sterile, isotonic...

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17 PATIENT COUNSELING INFORMATION

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

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This product's label may have been updated. For full prescribing information, please visit www.pfizer.com.

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.