Doxorubicin hydrochloride

Doxorubicin hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, AND SEVERE MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. Cardiomyopathy: Myocardial damage, including acute left ventricular failure can occur with doxorubicin HCl. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% - 20% for cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin HCl is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin HCl. Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin HCl. Extravasation and Tissue Necrosis: Extravasation of doxorubicin HCl can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area. Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.: (k)

Overview

Doxorubicin hydrochloride is an Antineoplastic and antibiotic that is FDA approved for the treatment of women with axillary lymph node involvement following resection of primary breast cancer, leukemias, lymphomas and metastasis neoplasms. There is a Black Box Warning for this drug as shown here. Common adverse reactions include alopecia, nauseas and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adjuvant in breast cancer

• Dosage: 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

Metastasic Neoplasm, Lymphomas or Leukemias

• The recommended dose of doxorubicin HCl when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days.
• The recommended dose of doxorubicin HCl, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days.
• Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy

Doxorubicin Hydrochloride is indicated for the following metastasic neoplasms
- Metastatic Breast cancer 
- Metastatic Wilms' tumor
- Metastatic Neuroblastoma
- Metastatic Soft tissue sarcoma
- Metastatic Bone sarcomas
- Metastatic Ovarian carcinoma
- Metastatic Transitional cell bladder carcinoma 
- Metastatic Thyroid carcinoma 
- Metastatic Gastric carcinoma
- Metastatic Bronchogenic carcinoma

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin Hydrochloride in adult patients.

Non–Guideline-Supported Use

Adrenal Carcinoma

• Multidrug dosage:
  • Doxorubicin 20 mg/m2 IV on days 1 and 8
  • Etoposide: 100 mg/m2 IV on days 5 through 7
  • Cisplatin: 40 mg/m2 IV on days 2 and 9

Bladder Carcinoma

• Multidrug Dosage:
  • Doxorubicin: 30 mg/m2 - day 2
  • Methotrexate: 30 mg/m2 - day 1, 15 and 22
  • Vinblastine: 3 mg/m2 - day 2, 15 and 22
  • Cisplatin: 70 mg/m2 - day 2

                                         This treatment must be applied for 3 cycles.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Doxorubicin hydrochloride FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Doxorubicin Hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Doxorubicin Hydrochloride in pediatric patients.

Contraindications

• Severe myocardial insufficiency
• Recent myocardial infarction
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment
• Hypersensitivity to doxorubicin HCl

Warnings

CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, AND SEVERE MYELOSUPPRESSION See full prescribing information for complete Boxed Warning. Cardiomyopathy: Myocardial damage, including acute left ventricular failure can occur with doxorubicin HCl. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1% - 20% for cumulative doses ranging from 300 mg/m2 to 500 mg/m2 when doxorubicin HCl is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess LVEF before and regularly during and after treatment with doxorubicin HCl. Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin HCl. Extravasation and Tissue Necrosis: Extravasation of doxorubicin HCl can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area. Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.: (k)

There is limited information regarding Doxorubicin hydrochloride Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Doxorubicin hydrochloride Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Doxorubicin hydrochloride Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Doxorubicin hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Doxorubicin hydrochloride in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Doxorubicin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Doxorubicin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Doxorubicin hydrochloride in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Doxorubicin hydrochloride in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Doxorubicin hydrochloride in geriatric settings.

Gender

There is no FDA guidance on the use of Doxorubicin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Doxorubicin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Doxorubicin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Doxorubicin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Doxorubicin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Doxorubicin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Doxorubicin hydrochloride Administration in the drug label.

Monitoring

There is limited information regarding Doxorubicin hydrochloride Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Doxorubicin hydrochloride and IV administrations.

Overdosage

There is limited information regarding Doxorubicin hydrochloride overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Doxorubicin hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Doxorubicin hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Doxorubicin hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Doxorubicin hydrochloride Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Doxorubicin hydrochloride Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Doxorubicin hydrochloride Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Doxorubicin hydrochloride Clinical Studies in the drug label.

How Supplied

There is limited information regarding Doxorubicin hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Doxorubicin hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Doxorubicin hydrochloride Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Doxorubicin Hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Doxorubicin hydrochloride Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Doxorubicin hydrochloride Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.