Pronunciation:

ix-ab-EP-i-lone

Brand Names:

• Ixempra

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Chemical—

Epothilone

Uses of This Medicine:

Ixabepilone injection is used alone or together with other medicine (eg, capecitabine) to treat metastatic (cancer that has spread) or locally advanced breast cancer in patients who have received other cancer treatments (eg, anthracyclines, taxanes, and capecitabine) that did not work well.

Ixabepilone injection belongs to the group of medicines called antineoplastics (cancer medicines). It 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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ixabepilone injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ixabepilone injection in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving this medicine.

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.

Other 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 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.

• Apalutamide
• Boceprevir
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Enzalutamide
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Lopinavir
• Lumacaftor
• Methotrexate
• Mitotane
• Nefazodone
• Nelfinavir
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Voriconazole

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with 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:

• Allergy to a medicine (eg, Taxol®) that contains Cremophor® EL or polyoxyethylated castor oil or
• Liver disease, severe or
• Neutropenia (low white blood cell count)—Should not be used in patients with these conditions.

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

• Heart disease, or history of or
• Peripheral neuropathy (nerve problem)—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to remain in place for at least 3 hours. It is usually given every 3 weeks.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have questions.

You may receive other medicines (eg, stomach medicine, allergy medicine, steroid medicine) at least 1 hour before receiving this medicine to help prevent unwanted reactions.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Precautions While Using This Medicine:

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.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 7 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant during treatment with this medicine, tell your doctor right away.

This medicine may cause nerve problems (eg, peripheral neuropathy). Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest pain, chills, cough, dizziness or lightheadedness, fast heartbeat, fever, itching, nausea or vomiting, runny or stuffy nose, sore throat, or trouble breathing after receiving this medicine.

Check with your doctor right away if you have chest pain, fast or uneven heartbeat, nausea, pain or discomfort in the arms, jaw, back ,or neck, sweating, trouble breathing, or vomiting. 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.

Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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 or vitamin supplements.

Side Effects of This Medicine:

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 or tightness

chills

cough

difficult or labored breathing

ear congestion

fever

headache

loss of voice

lower back or side pain

painful or difficult urination

pale skin

red, swelling, or painful skin

runny or stuffy nose

scaling of the skin on the hands and feet

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

tingling of the hands and feet

trouble breathing

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

Less common

Bleeding gums

blood in the urine or stools

confusion

decreased urination

dizziness

dry mouth

fainting

fast heartbeat

hives, itching, skin rash

hoarseness

increase in heart rate

irritation

joint pain, stiffness, or swelling

lightheadedness

pinpoint red spots on the skin

rapid breathing

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

trouble sleeping

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.