Halaven
Fruits, Veggies Tied to Lower Breast Cancer Risk »
"Dec. 6, 2012 -- Women now have one more reason to eat their fruits and veggies.
A new study suggests that women with higher levels of carotenoids (nutrients found in fruits and vegetables) have a lower risk of breast cancer -- especia"...
Read the Fruits, Veggies Tied to Lower Breast Cancer Risk article »
Halaven
Halaven Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Halaven (eribulin mesylate) is indicated for the treatment of metastatic breast cancer in patients who have had at least two chemotherapy treatments for metastatic disease. Halaven is not available in generic form. Common side effects of Halaven are low white blood cell count, anemia, weakness/fatigue, hair loss from head or body, nerve damage, nausea, and constipation.
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. Halaven may interact with other drugs. Tell your doctor all medications you use. Contact your doctor if you experience a fever of 100.5 or greater, have chills, cough, burning during urination or any other signs and symptoms of infection. You should not take Halaven if you are pregnant or breastfeeding.
Our Halaven (eribulin mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Halaven in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pain or burning when you urinate;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- severe numbness or tingling in your hands and feet;
- low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
Less serious side effects may include:
- weakness, tired feeling;
- hair loss;
- nausea, constipation, loss of appetite;
- headache; or
- muscle or joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Halaven (Eribulin Mesylate) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Halaven FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following adverse reactions are discussed in detail in other sections of the labeling:
- Neutropenia [see WARNINGS AND PRECAUTIONS]
- Peripheral neuropathy [see WARNINGS AND PRECAUTIONS]
- QT interval prolongation [see WARNINGS AND PRECAUTIONS ].
The most common adverse reactions ( ≥ 25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%).
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.
In clinical trials, HALAVEN has been administered to 1,222patients with multiple tumor types, including 240 patients exposed to HALAVEN for 6 months or longer. The majority of the 1,222patients were women (82%) with a median age of 58 years (range: 26 to 91 years). The racial and ethnic distribution was Caucasian (83%), Black (5%), Asian (2%), and other (5%).
The adverse reactions described in Table 2were identified in 750 patients treated in Study 1 [see Clinical Studies]. In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m² on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received HALAVEN, and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2reports the most common adverse reactions occurring in at least 10% of patients in either group.
Table 2: Adverse Reactions with a Per-Patient Incidence
of at Least 10% in Study 1
| MedDRA ver 10.0 | HALAVEN n=503 |
Control Group n=247 |
||
| All Grades | ≥ Grade 3 | All Grades | ≥ Grade 3 | |
| Blood and Lymphatic System Disordersa | ||||
| Neutropenia | 82% | 57% | 53% | 23% |
| Anemia | 58% | 2% | 55% | 4% |
| Nervous system disorders Peripheral neuropathyb | 35% | 8% | 16% | 2% |
| Headache | 19% | < 1% | 12% | < 1% |
| General disorders and administrative site conditions | ||||
| Asthenia/Fatigue | 54% | 10% | 40% | 11% |
| Mucosal inflammation | 9% | 1% | 10% | 2% |
| Pyrexia | 21% | < 1% | 13% | < 1% |
| Gastrointestinal disorders | ||||
| Constipation | 25% | 1% | 21% | 1% |
| Diarrhea | 18% | 0 | 18% | 0 |
| Nausea | 35% | 1% | 28% | 3% |
| Vomiting | 18% | 1% | 18% | 1% |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia/Myalgia | 22% | < 1% | 12% | 1% |
| Back pain | 16% | 1% | 7% | 2% |
| Bone pain | 12% | 2% | 9% | 2% |
| Pain in extremity | 11% | 1% | 10% | 1% |
| Investigations | ||||
| Weight decreased | 21% | 1% | 14% | < 1% |
| Metabolism and nutrition disorders | ||||
| Anorexia | 20% | 1% | 13% | 1% |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 14% | 0 | 9% | 0 |
| Dyspnea | 16% | 4% | 13% | 4% |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 45% | NAc | 10% | NAc |
| Infections and Infestations | ||||
| Urinary Tract Infection | 10% | 1% | 5% | |
| a based upon laboratory data. bincludes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. c not applicable; (grading system does not specify > Grade 2for alopecia). |
||||
Cytopenias
Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in < 1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia ( < 500/mm³) was 8 days. Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte-macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN.
Peripheral Neuropathy
In Study 1, 17 % of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received HALAVEN. Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients developed Grade 3 peripheral motor neuropathy.
Liver Function Test Abnormalities
Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade 2or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN.
Less Common Adverse Reactions
The following additional adverse reactions were reported in ≥ 5% to < 10% of the HALAVEN-treated group:
- Eye Disorders: increased lacrimation
- Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth
- General Disorders and Administration Site Conditions: peripheral edema
- Infections and Infestations: upper respiratory tract infection
- Metabolism and Nutrition Disorders: hypokalemia
- Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness
- Nervous System Disorders: dysgeusia, dizziness
- Psychiatric Disorders: insomnia, depression
- Skin and Subcutaneous Tissue Disorders: rash
Read the entire FDA prescribing information for Halaven (Eribulin Mesylate) »
Additional Halaven Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Breast Cancer
Find support and advances in treatment.
Updated & New
