Commonly asked questions about HALAVEN® (eribulin mesylate) Injection
What is HALAVEN?
HALAVEN is a prescription medicine developed from a natural substance found in a sea sponge, and is the only medicine discovered in its class of chemotherapy.
Who is HALAVEN for?
HALAVEN is a prescription medicine used to treat adults with breast cancer that has spread to other parts of the body, and who have already received other types of anticancer medicines after the cancer has spread.
To learn more about the disease, click here.
How effective is HALAVEN?
When used alone after 2 prior chemotherapies for mBC, HALAVEN is the only chemotherapy that has been proven in a clinical trial to help some women live longer.
In this trial of more than 750 women, HALAVEN was compared with other chemotherapies or hormone therapies commonly used to treat mBC. Although some women lived longer and some women did not live as long, women who were treated with HALAVEN lived an average of 13.2 months compared with women treated with other chemotherapy or hormone therapy, who lived an average of 10.6 months. This means that women who received HALAVEN lived 25% longer than women who received other chemotherapy or hormone therapy.
HALAVEN was studied in women with all types of tumor receptors. This means that their ER/PR hormone receptors (estrogen/progesterone receptors) were either positive or negative and their HER2/neu receptors (human epidermal growth factor receptor 2) were either positive or negative.
What safety information do I need to know about HALAVEN?
HALAVEN can cause serious side effects, including
- Low white blood cell count (neutropenia). This can lead to serious infections that could lead to death. Your health care provider will check your blood cell counts. Call your health care provider right away if you develop fever (temperature above 100.5°F), chills, cough, or burning or pain when you urinate, as any of these can be symptoms of infection
- Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your health care provider if you have new or worsening symptoms of peripheral neuropathy
- Your health care provider may delay or decrease your dose or stop treatment with HALAVEN if you have side effects
Before you receive HALAVEN, tell your health care provider about all of your medical conditions, including if you
- have liver or kidney problems
- have heart problems, including a problem called congenital long QT syndrome
- have low potassium or low magnesium in your blood
- are pregnant or plan to become pregnant. HALAVEN can harm your unborn baby. Tell your health care provider right away if you become pregnant or think you are pregnant during treatment with HALAVEN. Females who are able to become pregnant should use an effective form of birth control during treatment with HALAVEN and for at least 2 weeks after the final dose of HALAVEN and males should use an effective form of birth control when having sex with female partners who are able to become pregnant during treatment with HALAVEN and for 3½ months (14 weeks) after the final dose of HALAVEN
- are breastfeeding or plan to breastfeed. It is not known if HALAVEN passes into your breast milk. Do not breastfeed during treatment with HALAVEN and for 2 weeks after the final dose of HALAVEN
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of HALAVEN?
HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your health care provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.
The most common side effects of HALAVEN in adults with breast cancer include low white blood cell count (neutropenia), low red blood cell count (anemia), weakness or tiredness, hair loss (alopecia), nausea, and constipation.
Your health care provider will do blood tests before and during treatment while you are taking HALAVEN.
For more information about HALAVEN, please see full Prescribing Information.
How does HALAVEN work?
Based on early laboratory studies, HALAVEN works by limiting the growth of cancer cells, and ultimately killing them.
What should I tell my health care provider before receiving HALAVEN?
Tell your health care provider
- If you have liver or kidney problems or if you have heart problems, including congenital long QT syndrome
- If you have low potassium or low magnesium in your blood
- If you are pregnant or plan to become pregnant. HALAVEN may harm your unborn baby
- If you are breastfeeding or planning to breastfeed
- About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
What is the treatment schedule for HALAVEN?
HALAVEN is given by an injection into your vein (known as an intravenous, or IV, infusion). Each HALAVEN dose is given over a short period of 2 to 5 minutes. One cycle of treatment lasts 21 days, and consists of 1 IV infusion once a week for 2 weeks, and then 1 week without HALAVEN.
It is possible that there may be a reason your health care provider may delay or decrease your dose or stop treatment. Talk to him or her about any changes to your dosing schedule.
To see what a treatment cycle looks like, go here.
How long will I be on treatment with HALAVEN?
Your health care provider will decide how many cycles of HALAVEN treatment you will receive.
Will my insurance cover treatment with HALAVEN?
Coverage is different for different insurance plans. The Eisai Assistance Program (EAP) can help you get more information about your coverage, co-pays, deductibles, and other insurance information, or help you identify sources of potential coverage if you do not have insurance, including eligibility for the Eisai Patient Assistance Program (PAP). Eisai cannot guarantee coverage of any claim.
Eisai also offers co-pay assistance to eligible patients through the HALAVEN $0 Co-Pay Program, which helps with the out-of-pocket costs of HALAVEN (up to $18,000 per year). Restrictions apply. You can visit www.eisaireimbursement.com/ patient/halaven/financial-assistance www.eisaireimbursement.com/patient/halaven/financial-assistance to download an enrollment form.
To learn more about the PAP for HALAVEN and the HALAVEN $0 Co-Pay Program
Call 1.855.EISAI.4U (1855.347.2448)
Monday–Friday, 8 am to 5 pm, ET
To learn more about the Eisai Assistance Program (EAP)
Call 1.866.61.EISAI (1.866.613.4724)
Monday–Friday, 8 am to 8 pm, ET
Go to www.eisaireimbursement.com/