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doxorubicin hydrochloride

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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.

doxorubicin hydrochloride Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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:

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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

    6.1 Clinical Trials...

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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

  1. "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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