Ixempra Side Effects

Generic Name: ixabepilone

Please note - some side effects for Ixempra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ixempra - for the Consumer

Ixempra

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ixempra:

Constipation; diarrhea; dizziness; fingernail or toenail changes; hair loss; headache; hot flashes; loss of appetite; mild joint or muscle pain; mild weight loss; nausea; mouth sores; stomach pain or upset; taste changes; tiredness or weakness; trouble sleeping; or vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; difficult or painful urination; fainting; irregular heartbeat; numbness, tingling, or burning of the hands or feet; pain, swelling, redness, or blistering at the injection site; redness, tenderness, or dryness of the palms of hands or soles of feet; severe or persistent dizziness; severe or persistent nausea, vomiting, or diarrhea; severe tiredness or weakness; shortness of breath; signs of an infection (eg, fever, chills, cough, sore throat); swelling of arms, hands, legs, or feet; unusual bruising or bleeding; unusual weight gain.

Ixempra Side Effects - for the Professional

Ixempra

• The most common adverse reactions (≥20%) are peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. Additional reactions occurred in ≥20% in combination treatment: palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, and constipation (6).
• Drug-associated hematologic abnormalities (>40%) include neutropenia, leukopenia, anemia, and thrombocytopenia (6).

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Hematologic

Myelosuppression manifesting primarily as neutropenia can occur. It is generally dose-dependent and can result in infection or death. In clinical studies, grade 4 neutropenia (less than 500 cells/mm3) occurred in 36% of patients treated with ixabepilone in combination with capecitabine and 23% of patients treated with ixabepilone monotherapy. Patients should be monitored for myelosuppression with frequent peripheral blood cell counts. Dosage reduction should be instituted in patients who experience severe neutropenia or thrombocytopenia.

Hematologic side effects have included neutropenia, leukopenia, anemia, and thrombocytopenia in more than 40% of patients. Coagulopathy and lymphopenia have also been reported.

Hypersensitivity

Hypersensitivity reactions have been reported during ixabepilone use. Patients with a history of severe hypersensitivity reactions to agents containing polyoxyethylated castor oil should not be treated with ixabepilone. All patients should be premedicated with an H1 and an H2 antagonist approximately one hour before ixabepilone infusion and be observed for hypersensitivity reactions (e.g., flushing, rash, dyspnea and bronchospasm). If a severe hypersensitivity reaction occurs, ixabepilone infusion should be stopped and aggressive supportive treatment (e.g., epinephrine, corticosteroids) started. Patients experiencing a hypersensitivity reaction in one cycle of ixabepilone treatment must be premedicated in subsequent cycles with a corticosteroid in addition to the H1 and H2 antagonists. Extension of the infusion time should also be considered.

Of the 1323 patients treated with ixabepilone in clinical studies, nine patients (1%) experienced severe hypersensitivity reactions including anaphylaxis, and three of the 9 were able to be retreated.

Nervous system

Peripheral neuropathy is a commonly reported side effect associated with ixabepilone, often occurring early during treatment. Patients should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain. A reduction or delay in the dose of ixabepilone may be required in patients experiencing new or worsening symptoms. Extra caution should be used when treating patients with diabetes mellitus or existing moderate to severe neuropathy.

Nervous system side effects have included peripheral neuropathy, fatigue, and asthenia in more than 20% of patients. Insomnia, headache, dizziness, cognitive disorder, syncope, cerebral hemorrhage, abnormal coordination, lethargy, and hot flush have also been reported.

Cardiovascular

Cardiovascular side effects including myocardial ischemia, ventricular dysfunction, and supraventricular arrhythmias have been associated with ixabepilone use. Chest pain (5%), myocardial infarction, left ventricular dysfunction, angina pectoris, atrial flutter, cardiomyopathy, thrombosis, embolism, hemorrhage, hypovolemic shock, vasculitis and hypotension have also been reported.

The frequency of myocardial ischemia and ventricular dysfunction was higher when ixabepilone was used in combination with capecitabine (1.9%) than with capecitabine monotherapy (0.3%). Supraventricular arrhythmias were observed in the combination arm (0.5%) and not in the capecitabine monotherapy arm. Caution is recommended in patients with a history of cardiac disease, and discontinuation of ixabepilone should be considered in patients who develop cardiac ischemia or impaired cardiac function.

Musculoskeletal

Musculoskeletal side effects occurring in more than 20% of patients have included myalgia, arthralgia, musculoskeletal pain, and palmar-plantar erythrodysesthesia (hand-foot) syndrome. Muscular weakness, muscle spasms, and trismus have also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, stomatitis/mucositis, diarrhea, anorexia, abdominal pain, and constipation in more than 20% of patients. Gastroesophageal reflux (6%), taste disorder (6%), ileus, colitis, impaired gastric emptying, esophagitis, dysphagia, gastritis, enterocolitis, and gastrointestinal hemorrhage have also been reported.

Dermatologic

Dermatologic side effects have included alopecia (48%), skin rash (9%), and nail disorder (9%). Pruritus (6%), skin exfoliation, skin hyperpigmentation, and erythema multiforme have also been reported.

Respiratory

Respiratory side effects have included dyspnea (9%), upper respiratory tract infection (6%), and cough. Laryngitis, lower respiratory tract infection, pneumonia, pneumonitis, hypoxia, respiratory failure, acute pulmonary edema, dysphonia, and pharyngolaryngeal pain have also been reported.

Hepatic

Hepatic side effects have included acute hepatic failure, jaundice, increased transaminases, increased blood alkaline phosphatase, and increased gamma-glutamyltransferase.

Renal

Renal side effects have included nephrolithiasis, urinary tract infection, and renal failure.

Metabolic

Metabolic side effects have included hyponatremia, metabolic acidosis, hypokalemia, and hypovolemia.

Ocular

Ocular side effects including increased lacrimation (4%) have been reported.

Other

Other side effects have included edema (9%), pyrexia (8%), pain (8%), decreased weight (6%), sepsis, infection, bacterial infection, neutropenic infection, neutropenic fever, and chills.

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