"The result of a breast biopsy often determines the course of treatment and helps to predict a woman's risk of a future breast cancer diagnosis. Criteria for making diagnoses have been established, but it's been unclear how consistently patholo"...
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.
Read the entire detailed patient monograph for Halaven (Eribulin Mesylate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Halaven Overview - Patient Information: Side Effects
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, numbness/tingling/burning in the hands/feet, signs of anemia (such as unusual tiredness, pale skin).
This medication can lower the body's ability to fight an infection. Tell your doctor right away if you develop any signs of an infection such as fever, chills, cough, or burning/pain when you urinate.
Get medical help right away if any of these rare but serious side effects occur: fainting, fast/irregular heartbeat, severe dizziness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview 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
Clinical Trials Experience
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 1,222 patients with multiple tumor types, including 240 patients exposed to HALAVEN for 6 months or longer. The majority of the 1,222 patients 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 2 were 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 2 reports 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|
|Nervous system disorders|
|Headache||19%||< 1%||12%||< 1%|
|General disorders and administrative site conditions|
|Pyrexia||21%||< 1%||13%||< 1%|
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||11%||1%||10%||1%|
|Weight decreased||21%||1%||14%||< 1%|
|Metabolism and nutrition disorders|
|Respiratory, thoracic, and mediastinal disorders|
|Skin and subcutaneous tissue disorders|
|Infections and Infestations|
|Urinary Tract Infection||10%||1%||5%||0|
|abased upon laboratory data.
bincludes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia.
cnot applicable; (grading system does not specify > Grade 2 for 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 2 peripheral 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 2 or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations 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
The following adverse drug reactions have been identified during post-approval of HALAVEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and Lymphatic System Disorders: lymphopenia
- Gastrointestinal Disorders: pancreatitis
- Hepatobiliary Disorders: hepatotoxicity
- Immune System Disorders: drug hypersensitivity
- Infections and Infestations: pneumonia, sepsis/neutropenic sepsis
- Metabolism and Nutrition Disorders: hypomagnesemia, dehydration
- Respiratory, thoracic and mediastinal disorders: interstitial lung disease
- Skin and Subcutaneous Tissue Disorders: pruritus
Read the entire FDA prescribing information for Halaven (Eribulin Mesylate)
Additional Halaven Information
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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.
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