Ixempra® - TheGIConnection

Class:Chemotherapy

Generic Name: Ixabepilone (icks-uh-BEP-uh-lone)
Trade Name: Ixempra®

How is this drug used? Ixabepilone is FDA approved for the treatment of advanced breast cancer, in combination with the chemotherapy agent Xeloda® (capecitabine), among patients whose cancer has stopped responding to chemotherapy in the anthracycline or taxane classes. Ixabepilone is also FDA approved as a single agent for the treatment of advanced breast cancer among patients whose cancer has stopped responding to anthracyclines, taxanes, and Xeloda. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Ixabepilone belongs to a group of drugs referred to as microtubule inhibitors. Ixabepilone produces its anticancer effects by causing abnormalities in microtubule formation in cells. Microtubules are components of cells that provide structural framework that enables cells to divide and grow. The abnormal microtubule formation caused by ixabepilonel inhibits cellular replication and ultimately causes cellular death.

How is ixabepilone given (administered)? Ixabepilone is administered into a vein (intravenous). Allergic-type reactions may occur, although rarely, with treatment with ixabepilone. Therefore, all patients receive premedication against these reactions.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with ixabepilone. Typically, blood will be drawn to check levels of blood cells, particularly white blood cells, and to monitor functions of some organ systems, such as the liver or kidneys. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy. Patients may also have their reflexes monitored, as ixabepilone may cause numbness to the feet and hands. In addition, patients may also have their heart function monitored, as ixabepilonel has caused abnormalities to the heart, although this is extremely rare.

What are the common (occur in 30% or more of patients) side effects of treatment with ixabepilone?

Low white blood cells levels—increases risk of infection
Low red blood cells levels—increases risk of anemia and blood transfusion
Low platelet levels—increases risk for bleeding
Numbness or tingling of hands or feet
Joint pain
Muscle pain
Nausea
Loss of hair
Fatigue/weakness

What are the less common (occur in 10% to 29% of patients) side effects of treatment with ixabepilone?

Headache
Vomiting
Diarrhea
Weight loss/loss of appetite
Constipation
Abdominal pain
Mouth sores

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Pay careful attention to the physician's instructions and inform the physician of any side effects.
Maintain adequate rest and nutrition.
If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
Wash hands often to reduce the risk of infection.
Eat small, frequent meals in an attempt to relieve nausea.
Ask your healthcare provider about ice chips and salt/soda mixture for rinsing out your mouth to reduce mouth sores.
Avoid extreme heat or cold with extremities if they are numb.

Are there any special precautions patients should be aware of before starting treatment?

Patients should inform their physician if they are pregnant, breastfeeding, or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
Patients should check with their physician before starting any new drug or nutritional supplement.
Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
If patients are experiencing numbness or tingling of their hands or feet, they should be extremely cautious around extreme heat or cold.

When should patients notify their physician?

Fever
Chills
Sore throat
Cough
Flu or cold-like symptoms
Excessive or prolonged fatigue or weakness
Yellowing of skin or eyes
Changes in heart rate or rhythm
Difficulty in breathing
Chest pain
Excessive or prolonged nausea or vomiting
Severe or prolonged diarrhea
Numbness or changes in sensation in extremities
Severe pain
Signs of an allergic-type reaction—difficulty breathing, lightheadedness, or dizziness
Swelling of the feet or ankles
Prolonged constipation
Sores in the mouth

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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Tags: Chemotherapy, I