Note: This document contains side effect information about eribulin. Some dosage forms listed on this page may not apply to the brand name Halaven.

Summary

Common side effects of Halaven include: urinary tract infection, severe neutropenia, alopecia, anemia, arthralgia, asthenia, back pain, cough, fatigue, headache, myalgia, neutropenia, ostealgia, paresthesia, peripheral neuropathy, peripheral sensory neuropathy, polyneuropathy, weight loss, neuropathy, and anorexia. Other side effects include: febrile neutropenia, and peripheral motor neuropathy. Continue reading for a comprehensive list of adverse effects.

Applies to eribulin: intravenous solution.

Serious side effects of Halaven

Along with its needed effects, eribulin (the active ingredient contained in Halaven) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking eribulin:

More common

• Black, tarry stools
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• body aches or pain
• burning, numbness, tingling, or painful sensations
• chills
• convulsions
• cough
• decreased urine
• decreased weight
• difficult or labored breathing
• difficult, burning, or painful urination
• dry mouth
• ear congestion
• fever
• frequent urge to urinate
• headache
• increased thirst
• irregular heartbeat
• loss of appetite
• loss of voice
• lower back or side pain
• mood changes
• muscle pain or cramps
• nasal congestion
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• pale skin
• rapid weight gain
• runny nose
• sneezing
• sore throat
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness in the arms, hands, legs, or feet

Incidence not known

• Fainting
• irregular heartbeat, recurrent

Other side effects of Halaven

Some side effects of eribulin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• back pain
• belching
• bone pain
• change in taste
• cracked lips
• depression
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty with moving
• difficulty with swallowing
• dizziness
• hair loss or thinning of the hair
• heartburn
• indigestion
• lack or loss of strength
• loss of taste
• muscle spasm or weakness
• muscle stiffness
• pain in the arms or legs
• pain in the joints
• rash
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach discomfort, upset, or pain
• swelling or inflammation of the mouth
• trouble sleeping
• watering of the eyes
• weight loss

For Healthcare Professionals

Applies to eribulin: intravenous solution.

Hematologic

In one study, grade 3 neutropenia occurred in 28% of patients, 29% experience grade 4 neutropenia, and 5% of patients experienced febrile neutropenia. Dose reductions due to neutropenia occurred in 12% of patients and discontinuation was required in less than 1% of patients. Grade 3 or greater thrombocytopenia was reported in 1% of patients. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor was used in 19% of patients treated with this drug.^[Ref]

Very common (10% or more): Neutropenia (up to 82%), anemia (up to 58%)

Very common (10% or more): Urinary tract infection (up to 10%)

Uncommon (0.1% to 1%): Dysuria, hematuria, proteinuria, hematuria, leukopenia, lymphopenia^[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (up to 35%)

Common (1% to 10%): Dysgeusia, dizziness, hypoesthesia, lethargy, neurotoxicity, polyneuropathy, peripheral sensory neuropathy, paresthesia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 35%), constipation (up to 25%), diarrhea (up to 18%), vomiting (up to 18%)

Common (1% to 10%): Abdominal pain, stomatitis, dry mouth, dyspepsia, gastroesophageal reflux disease, mouth ulceration, mucosal inflammation, abdominal distension

Postmarketing reports: Pancreatitis^[Ref]

Cardiovascular

Common (1% to 10%): QT prolongation, tachycardia, peripheral edema^[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 45%)

Common (1% to 10%): Rash, pruritus, nail disorder, night sweats, palmar plantar erythrodysesthesia, dry skin, erythema, hyperhidrosis^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 10%)

Uncommon (0.1% to 1%): Dysuria, hematuria, proteinuria

v^[Ref]

Hepatic

Common (1% to 10%): Alanine aminotransferase increased, aspartate aminotransferase increased, gamma glutamyl transferase increased, hyperbilirubinemia^[Ref]

Metabolic

Very common (10% or more): Weight decreased (up to 21%), anorexia (up to 20%)

Common (1% to 10%): Hypokalemia^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia/Myalgia (up to 22%), back pain (up to 16%), bone pain (up to 12%), pain in extremity (up to 11%)

Common (1% to 10%): Muscle spasms, musculoskeletal pain, musculoskeletal chest pain^[Ref]

Ocular

Common (1% to 10%): Lacrimation increased, conjunctivitis^[Ref]

Other

Very common (10% or more): Asthenia/Fatigue (up to 54%), pyrexia (up to 21%)

Common (1% to 10%): Disseminated intravascular coagulation, oral herpes, mucosal inflammation, hot flushes, pain, chills, peripheral neuropathy, headache

Frequency not reported: Tinnitus^[Ref]

Psychiatric

Very common (10% or more): Headache

Common (1% to 10%): Insomnia, depression^[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 16%), cough (up to 14%)

Rare (less than 0.1%): Upper respiratory tract infection, nasopharyngitis, rhinitis

Frequency not reported: Oropharyngeal pain, epistaxis, rhinorrhea^[Ref]

Immunologic

Very common (10% or more):

Common (1% to 10%): Oral candidiasis, influenza-like illness, mucosal inflammation

Postmarketing reports: Pneumonia, sepsis/neutropenic sepsis^[Ref]