- Coding & Pricing
National Drug Codes (NDCs)
NDCs help physicians and payors identify specific product package sizes. The HALAVEN® NDC is listed below. The Eisai Assistance Program can answer any questions you have regarding the NDC for HALAVEN®.
| HALAVEN® Package Size | NDC |
|---|---|
| Single-dose vial containing 1.0 mg eribulin mesylate /2 ml solution in a 5ml vial - 1 vial in a carton | 62856-389-01 |
Some payors require physicians to report 11-digit NDCs when reporting a drug on a claim form. Converting the 10-digit NDC for HALAVEN® to an 11-digit NDC requires the use of a leading zero in the product code section of the NDC (i.e., the middle section):
| 10-Digit NDC Example | 11-Digit NDC Example With Leading Zero |
|---|---|
| AAAAA-BBB-CC | AAAAA-0BBB-CC |
| HALAVEN® 10-Digit NDC | HALAVEN® 11-Digit NDC with Leading Zero |
|---|---|
| 62856-389-01 | 62856-0389-01 |
The Eisai Assistance Program can provide information to patients and healthcare professionals relating to payor-specific policies and can address other questions at: 1-866-61-EISAI (1-866-613-4724).
Indication
- 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.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
- Severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes > 3 x ULN and bilirubin > 1.5 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia. Two patients died from complications of febrile neutropenia.
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral motor and sensory neuropathy.
- Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received HALAVEN®. Delay administration of HALAVEN® until resolution to Grade 2 or less.
- Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation.
Pregnancy Category D
- HALAVEN® is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks.
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on day 8, with no prolongation on day 1. ECG monitoring is recommended for patients with congestive heart failure, bradyarrhythmias, concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics and electrolyte abnormalities.
- Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN® and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients receiving HALAVEN® were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%).
- The most common serious adverse reactions reported were febrile neutropenia (4%) and neutropenia (2%).
Please see the HALAVEN® full prescribing information.
