Usual Adult Dose for Breast Cancer - Adjuvant

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

60 mg/m2 IV bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of 4 cycles

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: This drug is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer.

Usual Adult Dose for Breast Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Neuroblastoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for non-Hodgkin's Lymphoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Hodgkin's Disease

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Ovarian Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Wilms' Tumor

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Stomach Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Acute Lymphoblastic Leukemia

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Bladder Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Ewing's Sarcoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Acute Myeloblastic Leukemia

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Thyroid Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Bronchogenic Carcinoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Adult Dose for Soft Tissue Sarcoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days

In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Consider use of the lower dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: For the treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, 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.

Usual Pediatric Dose for Neuroblastoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol. Dosage in children may need to be reduced, please refer to treatment protocols and the specialist literature.

• As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
• In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: Pediatric tumors (e.g., neuroblastoma)

Usual Pediatric Dose for Malignant Disease

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol. Dosage in children may need to be reduced, please refer to treatment protocols and the specialist literature.

• As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
• In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Comments:

• The dosage of this drug depends on dosage regimen, general status and previous treatment of the patient.
• Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Use: Pediatric tumors (e.g., neuroblastoma)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Bilirubin level between 1.2 and 3 mg/dL: Reduce the dose by 50%.
Bilirubin level between 3.1 and 5 mg/dL: Reduce the dose by 75%.
Bilirubin level greater than 5 mg/dL: Do not initiate or discontinue therapy.
Severe liver impairment (Child Pugh C) or serum bilirubin greater than 5 mg/dL: Contraindicated

Dose Adjustments

NOTE: Dose and dosage regimens may vary according to manufacturer product information. Institutional protocol should be considered.

The dose of this drug may depend on whether other cytotoxic agents are to be given. Reference to specific protocols is recommended.

Cardiac Impairment: Discontinue this drug in patients who develop signs of cardiomyopathy.

Precautions

US BOXED WARNINGS:

• Cardiomyopathy: Myocardial damage can occur with this drug with incidences from 1% to 20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when it is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after ending therapy.
• Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including this drug.
• Extravasation and Tissue Necrosis: Extravasation of this drug can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate therapy and apply ice to the affected area.
• Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Severe myocardial insufficiency
• Recent (occurring within the past 4 to 6 weeks) myocardial infarction
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment (Child Pugh C) or serum bilirubin level greater than 5 mg/dL)

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is not interchangeable with other formulations of doxorubicin.
• Handle and dispose of this drug consistent with recommendations for the handling and disposal of hazardous drugs.
• Discard if the solution is discolored, cloudy, or contains particulate matter.
• Slow or continuous infusions over hours to days have been associated with less cardiotoxicity than bolus injections.
• Discard unused portion.

Storage requirements:

• Store unused vials at 20C to 25C (68F to 77F). Protect from light.
• Retain in carton until time of use.
• Storage of vials of this drug following reconstitution under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature (15C to 30C (59F to 86F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

IV compatibility:

• This drug is compatible with 0.9% sodium chloride injection or dextrose 5% injection.

Monitoring:

• Liver function
• Renal function

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