ix-ab-EP-i-loneIntravenous routePowder for Solution
Contraindicated with capecitabine in patients with AST or ALT greater than 2.5 times the upper limit of normal (ULN) or bilirubin greater than one times ULN due to increased risk of toxicity and neutropenia-related death .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Mitotic Inhibitor
Chemical Class: Epothilone
Ixabepilone belongs to the group of medicines called antineoplastics (cancer medicines). It is used to treat advanced or metastatic breast cancer (breast cancer that has already spread) after other treatments have failed. Ixabepilone is given alone or with another cancer medicine called capecitabine.
Ixabepilone interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells will also be affected by ixabepilone, other side effects may occur. Some of these may be serious and must be reported to your doctor right away.
ixabepilone is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ixabepilone, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to ixabepilone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of ixabepilone in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixabepilone in the elderly.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using ixabepilone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using ixabepilone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ixabepilone, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of ixabepilone. Make sure you tell your doctor if you have any other medical problems, especially:
Ixabepilone will be given only by or under the immediate supervision of your doctor. ixabepilone is given through a needle placed in one of your veins.
ixabepilone often causes diarrhea, nausea, and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Your doctor may give you a medicine to help prevent these side effects.
Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body. Do not eat grapefruit or drink grapefruit juice while you are using ixabepilone.
It is very important that your doctor check your progress at regular visits to make sure ixabepilone is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have chest pain, difficulty with breathing, a fast or pounding heartbeat, or unusual weight gain. These could be symptoms of a serious heart problem.
Using ixabepilone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
ixabepilone may cause peripheral neuropathy. Check with your doctor right away if you have numbness, tingling, or a burning pain in your arms, hands, legs, or feet.
Ixabepilone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood counts are low, to reduce the risk of infection or bleeding:
ixabepilone may cause a serious allergic reaction that can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection.
Make sure your doctor knows if you are allergic to a medicine (e.g., Taxol®) that contains Cremophor® EL or polyoxyethylated castor oil before you start using ixabepilone.
Ixabepilone contains alcohol, which may cause some people to become dizzy or drowsy. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are not alert .
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.
Along with its needed effects, a medicine 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:More common
Some side effects 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
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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