Eribulin Side Effects

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

For the Consumer

Applies to eribulin: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking eribulin: 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 of eribulin 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.

For Healthcare Professionals

Applies to eribulin: intravenous solution

Hematologic

Hematologic side effects have included neutropenia (82%), anemia (58%), febrile neutropenia, and thrombocytopenia.

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 eribulin.

Nervous system

Nervous system side effects have included peripheral neuropathy (35%), headache (19%), peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, paraesthesia, dysgeusia, and dizziness.

Gastrointestinal

Gastrointestinal side effects have included nausea (35%), constipation (25%), anorexia (20%), diarrhea (18%), vomiting (18%), mucosal inflammation (9%), dyspepsia, abdominal pain, stomatitis, and dry mouth.

Cardiovascular

Cardiovascular side effects have included QT interval prolongation and peripheral edema.

Dermatologic

Dermatologic side effects have included alopecia (45%) and rash.

Genitourinary

Genitourinary side effects have included urinary tract infection (10%).

Hepatic

Hepatic side effects have included increased liver enzymes and increased bilirubin.

Metabolic

Metabolic side effects have included weight loss (21%) and hypokalemia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia (22%), myalgia (22%), back pain (16%), bone pain (12%), pain in extremity (11%), muscle spasms, and muscular weakness.

Ocular

Ocular side effects have included increased lacrimation.

Other

Other side effects have included asthenia (54%), fatigue (54%) and pyrexia (21%).

Psychiatric

Psychiatric side effects have included insomnia and depression.

Respiratory

Respiratory side effects have included dyspnea (16%), cough (14%), and upper respiratory tract infection.

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