ixabepilone Intravenous

ix-ab-EP-i-lone

Intravenous route(Powder 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.

• Ixempra

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Chemical Class: Epothilone

Uses For ixabepilone

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 ixabepilone, other side effects may occur. Some of these may be serious and must be reported to your doctor right away.

ixabepilone is to be given only by or under the immediate supervision of your doctor.

Before Using ixabepilone

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:

Allergies

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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixabepilone injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
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.

Breast Feeding

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.

Interactions with Medicines

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 ixabepilone, 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 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.

• Amprenavir


• Atazanavir


• Carbamazepine


• Clarithromycin


• Delavirdine


• Dexamethasone


• Fosamprenavir


• Indinavir


• Itraconazole


• Ketoconazole


• Nefazodone


• Nelfinavir


• Phenobarbital


• Phenytoin


• Rifabutin


• Rifampin


• Ritonavir


• Saquinavir


• St John's Wort


• Telithromycin


• Voriconazole

Interactions with Food/Tobacco/Alcohol

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.

• Grapefruit Juice

Other Medical Problems

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:

• Allergy to a medicine (e.g., Taxol®) that contains Cremophor® EL or polyoxyethylated castor oil or


• Liver disease, severe or


• Neutropenia (low white blood cell count) or


• Thrombocytopenia (low platelet count)—Should not be used in patients with these conditions.

• Diabetes—Use with caution. ixabepilone may increase your chance of having nerve problems.

• Heart disease, or history of or


• Nerve problems (e.g., peripheral neuropathy)—Use with caution. May make these conditions worse.

• Liver disease, mild—Use with caution. ixabepilone should not be given with capecitabine to patients with this condition.

Proper Use of ixabepilone

A nurse or other trained health professional will give you ixabepilone in a hospital. ixabepilone is given through a needle placed in one of your veins.

ixabepilone 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.

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.

ixabepilone 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.

Precautions While 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.

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.

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:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as safety razors and fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

ixabepilone 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.

ixabepilone Side Effects

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

• Black, tarry stools


• body aches or pain


• burning, numbness, tingling, or painful sensations


• burning pain on urination


• chest pain


• chills


• cough


• difficult or labored breathing


• ear congestion


• fever


• headache


• loss of voice


• lower back or side pain


• nasal congestion


• painful or difficult urination


• pale skin


• red, swelling, or painful skin


• runny nose


• scaling of the skin on the hands and feet


• shortness of breath


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• swelling of the hands, ankles, feet, or lower legs


• swollen glands


• tightness in the chest


• tingling of the hands and feet


• troubled breathing with exertion


• ulceration of the skin


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain


• weakness in the arms, hands, legs, or feet


• wheezing

Less common

• Bleeding gums


• blood in the urine or stools


• confusion


• decreased urination


• dizziness


• dry mouth


• fainting


• fast heartbeat


• hives


• hoarseness


• increase in heart rate


• irritation


• itching


• joint pain, stiffness, or swelling


• lightheadedness


• pinpoint red spots on the skin


• rapid breathing


• rash


• sunken eyes


• swelling of the eyelids, face, or lips


• thirst


• trouble with swallowing


• wrinkled skin

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

• Bad, unusual, or unpleasant (after) taste


• bone pain


• change in taste


• cracked lips


• diarrhea


• difficulty having a bowel movement (stool)


• discoloration of the fingernails or toenails


• feeling of warmth


• hair loss or thinning of the hair


• heartburn


• lack or loss of strength


• loss of appetite


• nausea


• redness of the face, neck, arms, and occasionally, upper chest


• stomach pain


• sudden sweating


• swelling or inflammation of the mouth


• vomiting


• weight loss

Less common

• Darkening of the skin


• flaking and falling off of the skin


• sleeplessness


• trouble with sleeping


• unable to sleep


• watering of the eyes

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.

See also: ixabepilone Intravenous side effects (in more detail)

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More ixabepilone Intravenous resources

• Ixabepilone Intravenous Side Effects (in more detail)
• Ixabepilone Intravenous Use in Pregnancy & Breastfeeding
• Ixabepilone Intravenous Drug Interactions
• Ixabepilone Intravenous Support Group
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