Ixabepilone

Ixabepilone is a prescription medication used for the treatment of metastatic or locally advanced breast cancer.

• Ixabepilone is available under the following different brand names: Ixempra.

Common side effects of Ixabepilone include:

• blisters or severe rash on the palms of the hands or the soles of the feet, 
• headache, 
• tiredness, 
• joint or muscle pain, 
• lip, mouth, and esophagus sores, 
• hair loss, 
• fever, 
• anemia, 
• decreased platelets, 
• nausea, 
• vomiting, 
• stomach pain, 
• loss of appetite, 
• diarrhea, 
• constipation, and
• problems with the fingernails or toenails

Serious side effects of Ixabepilone include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• itching, 
• rash, 
• dizziness, 
• fainting, 
• warmth or tingly feeling, 
• chest tightness or pressure, 
• pounding heartbeats, 
• fluttering in the chest, 
• numbness, tingling, burning pain, discomfort, or loss of feeling anywhere in the body, 
• pain or burning while urinating, 
• unusual weight gain, 
• pain, blisters, bleeding, or severe rash on the palms of the hands or the soles of the feet, 
• chest pain, 
• fever, 
• chills, 
• tiredness, 
• mouth sores, 
• skin sores, 
• easy bruising, 
• unusual bleeding, 
• pale skin, 
• cold hands and feet, 
• lightheadedness, 
• shortness of breath, 
• sudden numbness or weakness, 
• problems with vision or speech, and
• swelling or redness in an arm or leg

Rare side effects of Ixabepilone include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for injection

• 15 mg/vial
• 45 mg/vial

Breast Cancer

Adult dosage

• 40 mg/m² IV infusions over 3 hours every 3 weeks; not to exceed 88 mg/dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ixabepilone has severe interactions with no other drugs.
• Ixabepilone has serious interactions with at least 30 other drugs.
• Ixabepilone has moderate interactions with at least 84 other drugs.
• Ixabepilone has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of hypersensitivity to Cremophor EL or its derivatives
• ANC is less than 1.5 K/m³ or Platelets is less than 100 K/m³
• Ixabepilone/capecitabine combo contraindicated if AST/ALT is above 2.5 times ULN or bilirubin is more than 1-time ULN

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ixabepilone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ixabepilone?”

Cautions

• Avoid grapefruit juice
• Strong CYP3A4 inducers (eg, rifampin) decrease ixabepilone AUC by 43% compared to ixabepilone treatment alone
• Cardiac adverse reactions (myocardial ischemia and ventricular dysfunction) occurred in patients receiving the drug in combination with capecitabine and as a single agent; supraventricular arrhythmias observed in patients receiving combination therapy; closely monitor patients with a history of cardiac disease during treatment; consider discontinuation of therapy in patients who develop cardiac ischemia or impaired cardiac function
• Severe, life-threatening, or fatal myelosuppression can occur with therapy; monitor patients receiving therapy for myelosuppression with frequent peripheral blood cell counts; withhold, reduce, or discontinue therapy depending on severity and persistence of myelosuppression
• Hepatic impairment
  • Monitor hepatic function before initiation of therapy and periodically thereafter
  • Dose reduction is recommended when administering the drug as a single agent to patients with hepatic impairment
  • Alcohol content of the drug should be taken into account when given to patients with hepatic impairment
• Peripheral neuropathy
  • Peripheral neuropathy (sensory and motor neuropathy) in patients treated in combination with capecitabine and those receiving monotherapy reported
  • Monitor patients for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain; closely monitor patients with diabetes mellitus or preexisting peripheral neuropathy
  • Withhold, reduce, or discontinue treatment depending on the severity and persistence of peripheral neuropathy

Pregnancy and Lactation

• Based on findings in animals and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; there are no available data on use in pregnant women to inform drug-associated risk; the drug contains alcohol which can interfere with neurobehavioral development
• The drug contains alcohol; published studies have demonstrated that alcohol is associated with fetal harm including central nervous system abnormalities, behavioral disorders, and impaired intellectual development
• Verify the pregnancy status of females of reproductive potential prior to initiating treatment
• Based on findings in animals, therapy may impair male and female fertility
• Contraception
  • Females: Advise females of reproductive potential to use effective contraception during treatment and for 7 months after the last dose
  • Males: Based on genotoxicity and animal studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months after the last dose
• Lactation
  • There is no data on the presence of drug in human milk, its effects on the breastfed child, or on milk production; the drug and/or its metabolites were present in the milk of lactating rats
  • Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 2 weeks after the last dose