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Metastatic Breast Cancer
HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [see Clinical Studies].
HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [see Clinical Studies].
DOSAGE AND ADMINISTRATION
The recommended dose of HALAVEN is 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of HALAVEN in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use in Specific Populations].
The recommended dose of HALAVEN in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use in Specific Populations].
The recommended dose of HALAVEN in patients with moderate to severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use in Specific Populations].
Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.
Recommended Dose Delays
- Do not administer HALAVEN on Day 1 or Day 8 for any of
- ANC < 1,000/mm³>
- Platelets < 75,000/mm³
- Grade 3 or 4 non-hematological toxicities.
- The Day 8 dose may be delayed for a maximum of 1 week.
- If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose.
- If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later.
Recommended Dose Reductions
- If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1.
- Do not re-escalate HALAVEN dose after it has been reduced.
Table 1: Recommended Dose Reductions
|Event Description||Recommended HALAVEN Dose|
|Permanently reduce the 1.4 mg/m² HALAVEN dose for any of the following:|
|ANC < 500/mm³ for > 7 days||1.1 mg/m²|
|ANC < 1,000 /mm³ with fever or infection|
|Platelets < 25,000/mm³|
|Platelets < 50,000/mm³ requiring transfusion|
|Non-hematologic Grade 3 or 4 toxicities|
|Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity|
|Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m²||0.7 mg/m²|
|Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m²||Discontinue HALAVEN|
|ANC = absolute neutrophil count.
Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Instructions For Preparation And Administration
Aseptically withdraw the required amount of HALAVEN from the single-use vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP.
Do not dilute in or administer through an intravenous line containing solutions with dextrose. Do not administer in the same intravenous line concurrent with the other medicinal products.
Store undiluted HALAVEN in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration (40°F or/ 4°C). Store diluted solutions of HALAVEN for up to 4 hours at room temperature or up to 24 hours under refrigeration.
Discard unused portions of the vial.
Dosage Forms And Strengths
Injection: 1 mg/2 mL (0.5 mg/mL).
Storage And Handling
Injection: 1 mg/2 mL, in a single-use vial. One vial per carton.
Store at 25°C (77°F); excursions permitted to 15° - 30° C (59° -86° F). Do not freeze. Store the vials in their original cartons.
Distributed by: Eisai Inc. Woodcliff Lake, NJ 07677. Revised: Oct 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/8/2016
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