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Halaven Side Effects

Generic Name: eribulin

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to eribulin: intravenous solution

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

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

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]

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]

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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

3. "Product Information. Halaven (eribulin)." Eisai Inc, Teaneck, NJ.

Some side effects of Halaven may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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