Ixabepilone in combination with capecitabine is contraindicated in patients with AST or ALT greater than 2.5 times the ULN or bilirubin greater than 1 time the ULN due to an increased risk of toxicity and neutropenia-related death .
Ixabepilone injection 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 this medicine, other side effects may occur. Some of these may be serious and must be reported to your doctor right away.
This medicine is to be given only by or under the immediate supervision of your doctor.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 injection in the pediatric population. Efficacy has not yet been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixabepilone injection 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.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine 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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
This medicine is usually given once every 3 weeks. Each treatment usually takes about 3 hours. You may also receive medicines to help prevent possible allergic reactions to the injection.
This medicine 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 this medicine.
This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine 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.
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
Ixabepilone injection 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:
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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 receive the medicine.
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.
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:
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:
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.