Applies to the following strengths: 2 mg/mL; 50 mg; 200 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Breast Cancer - Adjuvant
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer:
Starting Dose: 100 to 120 mg/m2 by intravenous infusion every 3 to 4 weeks. The total dose may either be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.
Renal Dose Adjustments
Although no specific dosage adjustments are available, lower doses should be considered in patients with severe renal impairment (serum creatinine >5 mg/dL).
Liver Dose Adjustments
If a patient has a bilirubin of 1.2 to 3 mg/dL or AST 2 to 4 times the upper limit of normal, then they should receive 1/2 of the normally recommended starting dose.
If a patient has a bilirubin >3 mg/dL or AST >4 times the upper limit of normal, then they should receive 1/4 of the normally recommended starting dose
Consideration should be given to administration of lower starting doses (75 to 90 mg/m2) for heavily pretreated patients, patients with preexisting bone marrow depression, or in the presence of neoplastic bone marrow infiltration.
Dosage adjustments after the first treatment cycle should be made based on both hematologic and nonhematologic toxicities. Patients experiencing nadir platelet counts <50,000/mm3, absolute neutrophil counts <250/mm3, neutropenic fever, or grades 3/4 nonhematologic toxicity should have the day 1 dose in subsequent cycles reduced to 75% of the Day 1 dose given in the current cycle. Day 1 chemotherapy in subsequent courses of treatment should be delayed until platelet counts are >=100,000/mm3, absolute neutrophil counts are >=1500/mm3, and nonhematologic toxicities have recovered to <=grade 1.
For patients receiving a divided dose (day 1 and day 8), the day 8 dose should be 75% of day 1 if platelet counts are 75,000 to 100,000/mm3 and the absolute neutrophil count is 1000 to 1499/mm3. If day 8 platelet counts are <75,000/mm3 , absolute neutrophil counts are <1000/mm3, or grade 3/4 nonhematologic toxicity has occurred, the day 8 dose should be omitted.
US BOXED WARNINGS:
SEVERE OR LIFE-THREATENING HEMATOLOGICAL AND OTHER ADVERSE REACTIONS:
-Severe local tissue necrosis will occur if there is extravasation during administration. This drug must not be given by the IM or subcutaneous route.
-Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated to be approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses exceeding 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity may occur at lower cumulative doses whether cardiac risk factors are present or not.
-Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including this drug. Refractory secondary leukemia occurs more often when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing therapy-related AML or myelodysplastic syndrome (MDS) in 7110 patients with breast cancer who received adjuvant treatment with this drug, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years.
-Severe myelosuppression may occur.
Consult WARNINGS section for additional precautions.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available.
In clinical trials, the patients administered the 120 mg/m2 regimen also received prophylactic antibiotic therapy with trimethoprim-sulfamethoxazole or a fluoroquinolone.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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