Ixabepilone

Ixabepilone is a prescription medication used to treat advanced breast cancer. Ixabepilone belongs to a group of medications called microtubule inhibitors. It has been proposed that ixabepilone gets inside the cancer cells and stop them from growing and dividing.

This medication comes in an injectable form that is given directly into your vein (IV) by a healthcare provider. Ixabepilone is usually given once every three weeks.

Common side effects include tiredness, loss of appetite, hair loss, fever, and headache.

Ixabepilone is a prescription medication that is used alone or with another cancer medicine called capecitabine. Ixabepilone is used to treat breast cancer when certain other medicines have not worked or no longer work.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ixabepilone may be found in some form under the following brand names:

• Ixempra

Ixabepilone may cause serious side effects. See "Ixabepilone Precautions" section.

The most common side effects with ixabepilone used alone or with capecitabine may include:

• tiredness
• loss of appetite
• problems with toenails and fingernails
• hair loss
• fever
• decreased red blood cells (anemia)
• joint and muscle pain
• headache
• decreased platelets (thrombocytopenia)
• nausea, vomiting, diarrhea, constipation, and abdominal pain
• sores on the lip, in the mouth and esophagus
• tender, red palms and soles of feet (hand-foot syndrome) that looks like a sunburn; the skin may become dry and peel. There may also be numbness and tingling.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all of the side effects of ixabepilone. Ask your healthcare provider or pharmacist for more information if you have questions or concerns.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Ixabepilone and certain other medicines may affect each other causing side effects. Ixabepilone may affect the way other medicines work, and other medicines may affect how ixabepilone works. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider.

Ixabepilone may cause serious side effects including:

• Numbness, tingling, or burning in the hands or feet can occur while receiving ixabepilone (neuropathy). These symptoms may be new or get worse while you are receiving ixabepilone. These symptoms often occur early during treatment with ixabepilone. Tell your healthcare provider if you have any of these symptoms. Your dose of ixabepilone may need to be decreased, stopped until your symptoms get better, or totally stopped.
• Low white blood cell count (neutropenia). White blood cells help protect the body from infections caused by bacteria. If you get a fever or infection when your white blood cells are very low, you can become seriously ill and die. You may need treatment in the hospital with antibiotic medicines. Your healthcare provider will monitor your white blood cell count often with blood tests. Tell your healthcare provider right away or go to the nearest hospital emergency room if you have a fever (temperature above 100.5° F) or other sign of infection, such as chills, cough, burning or pain when you urinate, anytime between treatments with ixabepilone.
• Allergic Reactions. Severe allergic reactions can occur with ixabepilone and may cause death in rare cases. Allergic reactions are most likely to occur while ixabepilone is being injected into your vein. Tell your healthcare provider right away if you get any of the following signs and symptoms of an allergic reaction:
  • itching, hives (raised itchy welts), rash
  • flushed face
  • sudden swelling of face, throat or tongue
  • chest tightness, trouble breathing
  • feel dizzy or faint
  • feel your heart beating (palpitations)

• Harm to an unborn child. See the pregnancy section for information.

• Heart problems. Ixabepilone might cause decreased blood flow to the heart, problems with heart function, and abnormal heartbeat. This is seen more often in patients who also take capecitabine. Tell your healthcare provider right away if you have any of the following symptoms:
  • chest pain,
  • difficulty breathing,
  • feel your heart beating (palpitations), or
  • unusual weight gain.

Your healthcare provider should do blood tests to check your liver function:

• before you begin receiving ixabepilone
• as needed while you are receiving ixabepilone

If blood tests show that you have liver problems, do not receive injections of ixabepilone along with the medicine capecitabine. Taking these two medicines together if you have liver problems increases your chance of serious problems. These include serious infection and death due to a very low white blood cell count (neutropenia).

Do not receive injections of ixabepilone if you:

• are allergic to a medicine, such as Taxol, that contains Cremophor EL or polyoxyethylated castor oil.
• have low white blood cell or platelet counts. Your healthcare provider will check your blood counts.
• are also taking a cancer medicine called capecitabine and you have liver problems.

Ixabepilone contains alcohol. If you are dizzy or drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

Do not drink grapefruit juice while receiving ixabepilone. Drinking grapefruit juice may cause you to have too much ixabepilone in your blood and lead to side effects.

Before you receive ixabepilone, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have heart problems or a history of heart problems
• have had an allergic reaction to ixabepilone. You will receive medicines before each injection of ixabepilone to decrease the chance of an allergic reaction. 
• are pregnant or breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ixabepilone falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if ixabepilone crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ixabepilone.

Ixabepilone is given by an injection directly into your vein (IV). Ixabepilone is usually given once every three weeks. Each treatment with ixabepilone will take about 3 hours.

Your healthcare provider will decide how much ixabepilone you will receive and how often you will receive it.

To lower the chance of allergic reaction, you will receive other medicines about 1 hour before each treatment with ixabepilone.

If you have an allergic reaction to ixabepilone, you will receive a steroid medicine before future doses of ixabepilone. You may also need to receive your doses of ixabepilone more slowly.

The recommended dosage of ixabepilone is 40 mg/m² given into the vein over 3 hours every 3 weeks.

The dose may be reduced in certain patients with elevated liver enzymes.

Ixabepilone is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if an overdose is suspected, seek emergency medical attention.

WARNING: TOXICITY IN HEPATIC IMPAIRMENT

Ixabepilone in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death.