Generic Name: PACLITAXEL PROTEIN-BOUND - INJECTION
Pronounced: (pack-lih-TAX-el)

Abraxane IV Warning

This medication may often cause a serious blood disorder (decreased bone marrow function leading to a low number of white blood cells). This effect can lower your body's ability to fight an infection. Your doctor will monitor you closely and check your blood often during treatment. If your white blood cell count is too low, you should not receive this medication. Tell your doctor immediately if you develop any signs of infection (e.g., fever, chills, cough, persistent sore throat, painful/difficult urination).

This medication contains a form of paclitaxel that is bound to a human protein called albumin. This product acts differently in the body than other forms of paclitaxel. Therefore, this product should not be substituted for or used with any other forms of paclitaxel.

Abraxane IV Side Effects

See also Warning section.

Nausea, vomiting, diarrhea, mouth sores, headache, muscle/joint pain, numbness/tingling/burning of the hands/feet, weakness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor promptly.

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

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

Tell your doctor immediately if any of these unlikely but serious side effects occur:

• signs of anemia (e.g., unusual tiredness, pale skin)
• easy bruising/bleeding
• fast/slow/irregular heartbeat
• pain/redness/swelling/weakness of the arms/legs
• calf pain/swelling that is warm to the touch
• vision changes

This medication may infrequently irritate the vein it is given into or leak out of the vein and irritate the area. These effects may cause redness, pain, swelling, discoloration, or unusual skin reactions at the injection site, either while the drug is given or rarely 7 to 10 days later. If this drug has leaked out of a vein and caused a skin reaction in the past, you may rarely have a skin reaction in that same area when the drug is given again, even when it is given into another area. Tell your doctor immediately of any unusual skin/injection site symptoms.

Seek immediate medical attention if any of these rare but very serious side effects occur:

• chest/jaw/left arm pain
• coughing up blood
• fainting
• weakness on one side of the body
• slurred speech
• confusion
• sudden severe headache

A very serious allergic reaction to this drug is rare. Do not restart this medication if you have previously stopped using it due to a serious allergic reaction. Seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:

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

This medication contains albumin that comes from human blood. There is a very small chance that you may get infections from this medication (e.g., viral infections such as hepatitis), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any of the following:

• signs of infection (e.g., fever, chills, cough, persistent sore throat)
• signs of hepatitis (e.g., persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, increasing tiredness)

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.

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

Abraxane IV Precautions

Before using paclitaxel, tell your doctor or pharmacist if you are allergic to it; or to albumin; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

• a very low white blood cell count

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

• blood disorders
• decreased bone marrow function
• current infections
• heart problems (e.g., fast/slow/irregular heartbeat)
• high or low blood pressure
• liver disease

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

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

Men using this medication should not plan to father a child while receiving treatment. This medication may affect sperm production in men and increase the risk of harm to the unborn baby. Therefore, reliable forms of birth control should be used during treatment and for some time afterwards. Consult your doctor for more details. If your partner becomes pregnant while you are using this medication, tell your doctor immediately.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms, birth control pills) while using this medication and for some time afterwards. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Abraxane IV Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Copyright 2007 First DataBank, Inc.