Ixempra

Ixempra is a prescription medication used to treat advanced breast cancer. Ixempra belongs to a group of medications called microtubule inhibitors. It has been proposed that Ixempra 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. Ixempra is usually given once every three weeks.

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

Ixempra is a prescription medication that is used alone or with another cancer medicine called capecitabine. Ixempra 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.

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

The most common side effects with Ixempra 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 Ixempra. 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.

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

Ixempra may cause serious side effects including:

• Numbness, tingling, or burning in the hands or feet can occur while receiving Ixempra (neuropathy). These symptoms may be new or get worse while you are receiving Ixempra. These symptoms often occur early during treatment with Ixempra. Tell your healthcare provider if you have any of these symptoms. Your dose of Ixempra 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 Ixempra.
• Allergic Reactions. Severe allergic reactions can occur with Ixempra and may cause death in rare cases. Allergic reactions are most likely to occur while Ixempra 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. Ixempra 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 Ixempra 
• as needed while you are receiving Ixempra 

If blood tests show that you have liver problems, do not receive injections of Ixempra 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 Ixempra 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.

Ixempra 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 Ixempra. Drinking grapefruit juice may cause you to have too much Ixempra in your blood and lead to side effects.

Before you receive Ixempra, 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 Ixempra. You will receive medicines before each injection of Ixempra 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.

Ixempra 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 Ixempra 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 Ixempra.

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

Your healthcare provider will decide how much Ixempra 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 Ixempra.

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

The recommended dosage of Ixempra 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.

Ixempra 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

Ixempra 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.