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

Applies to ixabepilone: intravenous powder for solution.

Serious side effects of Ixempra

Along with its needed effects, ixabepilone (the active ingredient contained in Ixempra) 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 ixabepilone:

More common

• Black, tarry stools
• body aches or pain
• burning, numbness, tingling, or painful sensations
• burning pain on urination
• chest pain or tightness
• chills
• cough
• difficult or labored breathing
• ear congestion
• fever
• headache
• loss of voice
• lower back or side pain
• painful or difficult urination
• pale skin
• red, swelling, or painful skin
• runny or stuffy nose
• scaling of the skin on the hands and feet
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• swelling of the hands, ankles, feet, or lower legs
• swollen glands
• tingling of the hands and feet
• trouble breathing
• ulceration of the skin
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain
• weakness in the arms, hands, legs, or feet

Less common

• Bleeding gums
• blood in the urine or stools
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• fast heartbeat
• hives, itching, skin rash
• hoarseness
• increase in heart rate
• irritation
• joint pain, stiffness, or swelling
• lightheadedness
• pinpoint red spots on the skin
• rapid breathing
• sunken eyes
• swelling of the eyelids, face, or lips
• thirst
• trouble with swallowing
• wrinkled skin

Other side effects of Ixempra

Some side effects of ixabepilone 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

• Bad, unusual, or unpleasant (after) taste
• bone pain
• change in taste
• cracked lips
• diarrhea
• difficulty having a bowel movement (stool)
• discoloration of the fingernails or toenails
• feeling of warmth
• hair loss or thinning of the hair
• heartburn
• lack or loss of strength
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain
• sudden sweating
• swelling or inflammation of the mouth
• vomiting
• weight loss

Less common

• Darkening of the skin
• flaking and falling off of the skin
• trouble sleeping
• watering of the eyes

For Healthcare Professionals

Applies to ixabepilone: intravenous powder for injection.

Hematologic

Very common (10% or more): Neutropenia (Grade 4) (36%), leukopenia (41%)

Common (1% to 10%): Febrile neutropenia, infection with neutropenia, anemia, thrombocytopenia

Frequency not reported: Coagulopathy, lymphopenia, hemorrhage^[Ref]

Hypersensitivity

Common (1% to 10%): Flushing, rash, dyspnea, bronchospasm, anaphylaxis^[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (all Grades) (67%), sensory neuropathy (65%), peripheral neuropathy (Grade 3 or 4) (23%), motor neuropathy (16%), taste disorder (12%)

Common (1% to 10%): Headache, dizziness

Frequency not reported: Cognitive disorder, syncope, cerebral hemorrhage, abnormal coordination, lethargy^[Ref]

Cardiovascular

Common (1% to 10%): Myocardial ischemia, ventricular dysfunction, hot flush

Uncommon (0.1% to 1%): Supraventricular arrhythmia

Frequency not reported: Myocardial infarction, supraventricular arrhythmia, left ventricular dysfunction, angina pectoris, atrial flutter, cardiomyopathy, myocardial ischemia, hypotension, thrombosis, embolism, hypovolemic shock, vasculitis^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia/arthralgia (39%), musculoskeletal pain (23%)

Frequency not reported: Muscular weakness, muscle spasms, trismus^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (53%), abdominal pain (24%), constipation (22%), stomatitis/mucositis, diarrhea

Common (1% to 10%): Dehydration, gastroesophageal reflux disease

Frequency not reported: Enterocolitis, ileus, colitis, impaired gastric emptying, esophagitis, dysphagia, gastritis, GI hemorrhage^[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome (64%), alopecia (31%), nail disorder (24%), skin rash (17%), skin hyperpigmentation (14%)

Common (1% to 10%): Pruritus, skin exfoliation

Frequency not reported: Erythema multiforme

Postmarketing reports: Radiation recall^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, dyspnea, cough

Frequency not reported: Pneumonia, laryngitis, lower respiratory tract infection, pneumonitis, hypoxia, respiratory failure, acute pulmonary edema, dysphonia, pharyngolaryngeal pain^[Ref]

Hepatic

Frequency not reported: Acute hepatic failure, jaundice, increased transaminases, increased blood alkaline phosphatase, increased gamma-glutamyltransferase^[Ref]

Renal

Frequency not reported: Nephrolithiasis, renal failure^[Ref]

Metabolic

Very common (10% or more): Anorexia (34%), weight loss (11%)

Frequency not reported: Hyponatremia, metabolic acidosis, hypokalemia, hypovolemia^[Ref]

Ocular

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

Other

Very common (10% or more): Fatigue/asthenia (60%), pyrexia (10%)

Common (1% to 10%): Edema, pain, chest pain

Frequency not reported: Chills^[Ref]

Immunologic

Frequency not reported: Sepsis, infection, neutropenic infection, bacterial infection^[Ref]

Psychiatric

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

Genitourinary

Frequency not reported: Urinary tract infection^[Ref]