IXEMPRA (ixabepilone)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Severe hepatic disease

There are 9 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiac arrhythmia
Disease of liver
Hyperbilirubinemia
Myocardial ischemia
Neutropenic disorder
Peripheral neuropathy
Pregnancy
Severe infection
Thrombocytopenic disorder

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Diabetes mellitus

There are 46 severe adverse reactions.

More Frequent	Less Frequent
Leukopenia Neutropenic disorder Peripheral neuropathy	Anemia Angina Atrial flutter Chest pain Dehydration Dyspnea Exfoliative dermatitis Hypersensitivity drug reaction Hypokalemia Hyponatremia Hypovolemia Infection Palmar-plantar erythrodysesthesia Thrombocytopenic disorder Vasculitis

Rare/Very Rare

Abnormal hepatic function tests Acute hepatic failure Acute myocardial infarction Bronchospastic pulmonary disease Cardiomyopathy Colitis Erythema multiforme Gastritis Gastrointestinal hemorrhage Hemorrhage Hepatic failure Hypersensitivity pneumonitis Hypotension Ileus Increased risk of bleeding due to coagulation disorder Intracerebral hemorrhage Jaundice Kidney stone Metabolic acidosis Myocardial ischemia Pulmonary edema Radiation recall syndrome Renal failure Skin rash Supraventricular arrhythmias Syncope Thromboembolic disorder Thrombotic disorder

There are 37 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Alopecia Anorexia Arthralgia Constipation Diarrhea Fatigue General weakness Headache disorder Myalgia Nausea Stomatitis Vomiting	Ataxia Cough Dizziness Dyschromia Dysgeusia Edema Eye tearing Fever Gastroesophageal reflux disease Insomnia Lethargy Lymphopenia Nail disorders Pain Pruritus of skin Trismus Upper respiratory infection Voice change Weight loss

Rare/Very Rare
Acute cognitive impairment Chills Dysphagia Flushing Muscle spasm

Category D. (See Users Guide.)

Not known whether ixabepilone is distributed into human milk; however, in lactating rats given radiolabeled ixabepilone, concentrations of radioactivity in milk were comparable to those in plasma and declined in parallel with plasma concentrations of the drug. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Clinical studies of ixabepilone did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. In clinical studies, 45 out of 431 breast cancer patients receiving ixabepilone and capecitabine in combination were 65 years of age or older and 3 patients were 75 years of age or older. Overall, the incidence of grade 3 or 4 adverse reactions was higher in geriatric patients 65 years of age and older compared with younger patients (82 and 68%, respectively); these reactions included stomatitis, diarrhea, palmar-plantar erythrodysesthesia syndrome, peripheral neuropathy, febrile neutropenia, fatigue, and asthenia.

Toxicity-related deaths occurred in 2 out of 43 (4.7%) patients 65 years of age or older with normal baseline hepatic function or mild hepatic impairment. In clinical studies, 32 out of 240 breast cancer patients receiving ixabepilone as monotherapy were 65 years of age or older and 6 patients were 75 years of age or older. No overall differences in safety were observed in these patients compared with those younger than 65 years of age.