sp; a Efficacy data from one study site enrolling six patients were excluded.
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC 62856-389-01
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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Neutropenia
Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination [see Warnings and Precautions (5.1)].
Peripheral Neuropathy
Advise patients to inform their healthcare providers of new or worsening numbness, tingling and pain in their extremities [see Warnings and Precautions (5.2)].
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.3), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks after the final dose [see Use in Specific Populations (8.3)].
Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose [see Use in Specific Populations (8.3)].
Lactation
Advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose [see Use in Specific Populations (8.2)]
Distributed by:
Eisai Inc.
Woodcliff Lake, NJ 07677
© 2016 Eisai Inc.
PATIENT PACKAGE INSERT
PATIENT INFORMATION
HALAVEN® (HAL-ih-ven)
(eribulin mesylate)
injection, for intravenous use
What is the most important information I should 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 healthcare provider will check your blood cell counts before you receive each dose of HALAVEN and during treatment. Call your healthcare provider right away if you develop any of these symptoms of infection:
° fever (temperature above 100.5°F)
° chills
° cough
° burning or pain when you urinate
Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your healthcare provider if you have new or worsening symptoms of peripheral neuropathy.
Your healthcare provider may delay, decrease your dose, or stop treatment with HALAVEN if you have side effects.
See “What are possible side effects of HALAVEN?” for more information about side effects.
What is HALAVEN?
HALAVEN is a prescription medicine used to treat people with:
Breast cancer
° that has spread to other parts of the body, and
° who have already received certain types of anticancer medicines after the cancer has spread
Liposarcoma
° that cannot be treated with surgery or has spread to other parts of the body, and
° who have received treatment with a certain type of anticancer medic |
