Ixempra 15 mg intravenous solution

Generic name:
Ixabepilone - injection

Pronunciation
(IX-a-BEP-i-lone)

Brand name(s)
Ixempra

Ixabepilone should not be used with capecitabine if blood tests show you have liver problems. Using these 2 medications together may increase the risk of severe (sometimes fatal) immune problems and serious infection.

This medication is used to treat advanced breast cancer. Ixabepilone is a chemotherapy drug that works to slow or stop cancer cell growth.

Read the Patient Information Leaflet if available from your pharmacist before you start using ixabepilone and each time you receive a dose. If you have any questions, ask your doctor or pharmacist.

This medication is usually given by injection into a vein over 3 hours by a health care professional. It is given as directed by your doctor, usually every 3 weeks. You will need blood tests (complete blood count) before each appointment. Your doctor will adjust the dosage and how often you receive the medication based on the blood tests.

Your doctor will direct you to take 2 types of antihistamines (such as diphenhydramine and ranitidine) by mouth 1 hour before your treatment to prevent or lessen a severe allergic reaction. Your doctor may give you another medication (a corticosteroid such as dexamethasone) and give ixabepilone over more than 3 hours if you had a severe reaction during your last treatment.

The dosage is based on your medical condition, body size, and response to treatment.

Pain/redness/swelling at the injection site, weakness, tiredness, muscle/joint pain, nausea, vomiting, diarrhea, loss of appetite, headache, dizziness, or drowsiness may occur. Nausea and vomiting may be severe in some patients. Your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication can lower your body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as sore throat that doesn't go away, painful urination, fever, or chills.

Painful sores on the lips, mouth, and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water.

Tell your doctor right away if you have any serious side effects, including:

• swollen hands/ankles/feet
• fainting
• pale skin
• easy/unusual bruising/bleeding
• sudden weight gain
• signs of dehydration (such as decreased urination, increased thirst, dry mouth)

Ixabepilone can sometimes affect how your nerves work (peripheral neuropathy). Tell your doctor right away if you develop pain/burning/numbness/tingling of the hands/feet.

You may lessen these types of nerve problems by avoiding cold drinks and ice and by dressing warmly. Tell your doctor right away if your nerve problems begin to interfere with your normal daily activities (such as walking, writing, eating).

Treatment with ixabepilone may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia), especially when this drug is given with capecitabine. You can prevent or reduce these problems by protecting your hands and feet from a great deal of heat or pressure. Avoid unnecessary exposure to heat (such as hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (such as leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may prescribe a medication to reduce the symptoms or decrease/delay your next treatment. If you experience pain/swelling/redness, blisters, or numbness of the hands/feet that affects your usual activities, tell your doctor right away.

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• shortness of breath
• chest pain
• bloody/black stools
• vomit that looks like coffee grounds
• vision changes
• seizures
• sudden confusion

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• face flushing
• tight feeling in chest
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using ixabepilone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems
• diabetes
• heart problems (such as chest pain, heart failure, heart attack)
• liver problems
• bone marrow problems (such as low white count, anemia)
• nerve problem (peripheral neuropathy)

This medication contains alcohol. It may make you dizzy or drowsy. Marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Tell your health care professional that you are using ixabepilone before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ixabepilone. Ixabepilone may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 7 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• drugs that cause a reaction with alcohol (such as disulfiram, metronidazole)

Other medications can affect the removal of ixabepilone from your body, which may affect how ixabepilone works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), rifamycins (such as rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.