Abraxane

Pronunciation: PAK-li-TAX-el
Generic Name: Paclitaxel
Brand Name: Abraxane

Abraxane must be administered in an appropriate medical setting under close medical supervision. Patients with metastatic breast cancer who also have extremely low neutrophil (a type of white blood cell) counts should not use Abraxane. Frequent blood tests should be performed while you are using Abraxane because of the risk of bone marrow suppression and serious infection.

Do not substitute or interchange Abraxane with other forms of paclitaxel.

Abraxane is used for:

Treating breast cancer in certain patients. It may also be used for other types of cancer as determined by your doctor.

Abraxane is a chemotherapy medicine. It works by slowing or stopping cancer cells from dividing and growing, so they eventually die.

Do NOT use Abraxane if:

• you are allergic to any ingredient in Abraxane


• you have extremely low white blood cell counts (eg, extremely low neutrophil counts)


• you have shingles or chickenpox

Contact your doctor or health care provider right away if any of these apply to you.

Before using Abraxane:

Some medical conditions may interact with Abraxane. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances (including albumin)


• if you have a bacterial or viral infection, or HIV infection


• if you have a history of a heart attack or other heart problems (eg, irregular heartbeat), liver or kidney problems, bone marrow problems, or blood problems (eg, low blood platelet or neutrophil counts)


• if you are undergoing radiation therapy


• if you have ever had an allergic reaction to an insect sting

Some MEDICINES MAY INTERACT with Abraxane. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, itraconazole, ketoconazole), benzodiazepines (eg, midazolam, triazolam), buspirone, cimetidine, cisplatin, eletriptan, felodipine, fluoxetine, gemfibrozil, HIV protease inhibitors (eg, indinavir, ritonavir), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), macrolides (eg, clarithromycin, erythromycin), nefazodone, repaglinide, rosiglitazone, sildenafil, or telithromycin because they may increase the risk of Abraxane's side effects


• Carbamazepine, efavirenz, nevirapine, phenytoin, or rifampin because they may decrease Abraxane's effectiveness


• Anticoagulants (eg, warfarin) or doxorubicin because the risk of their side effects may be increased by Abraxane

This may not be a complete list of all interactions that may occur. Ask your health care provider if Abraxane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Abraxane:

Use Abraxane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Abraxane. Talk to your pharmacist if you have questions about this information.


• Abraxane is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.


• Wear gloves while handling Abraxane.


• If you get Abraxane on your skin, rinse the area thoroughly with soap and water. If you get Abraxane in your eyes, nose, or mouth, flush the area thoroughly with water.


• If you miss a dose of Abraxane, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Abraxane.

Important safety information:

• Some patients develop redness or sores in the mouth or on the lips. These symptoms may occur a few days after treatment with Abraxane and usually decrease or disappear in 1 week. Talk with your doctor about proper mouth care and other ways to prevent or reduce this side effect.


• Abraxane may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Abraxane with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Abraxane contains albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Abraxane.


• Abraxane may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Abraxane may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.


• Talk with your doctor before you receive any vaccine.


• Tell your doctor or dentist that you take Abraxane before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood cell counts and liver function, may be performed while you use Abraxane. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Abraxane should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• Women who may become pregnant should use effective birth control (eg, condoms) while using Abraxane. Talk with your doctor if you have questions about effective birth control.


• Men should not father a child while using Abraxane. Use effective birth control when having sex with a woman who may become pregnant. Talk with your doctor if you have questions about effective birth control.


• PREGNANCY AND BREAST-FEEDING: Abraxane has been shown to cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Abraxane while you are pregnant. It is not known if Abraxane is found in breast milk. Do not breast-feed while using Abraxane.

Possible side effects of Abraxane:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; general feeling of discomfort; hair loss; mild discomfort, redness, or swelling at the injection site; mild joint or muscle pain; nausea; numbness, tingling, or burning of the arms, hands, legs, or feet; redness and/or sores on the mouth or lips; weakness or tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; flushing; swelling of the mouth, face, lips, tongue, or throat; hoarseness); blistering, swelling, redness, severe pain, or open sores on the skin or at the injection site; calf or leg redness, swelling, pain, or tenderness; change in the amount of urine produced; chest pain; fainting; fast, slow, or irregular heartbeat; pale appearance; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or diarrhea; severe or persistent numbness, tingling, or burning in the arms, hands, legs, or feet; severe or persistent stomach pain; sudden or severe dizziness, light-headedness, or headache; swelling of the arms, hands, legs, or feet; symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include burning, numbness, or tingling; redness and/or sores on the mouth or lips; symptoms of infection (eg, fever, chills, persistent sore throat); unusual bruising or bleeding; unusual tiredness or weakness.

Proper storage of Abraxane:

Store Abraxane as directed on the prescription label. Keep Abraxane out of the reach of children and away from pets.

General information:

• If you have any questions about Abraxane, please talk with your doctor, pharmacist, or other health care provider.


• Abraxane is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Abraxane. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.