Abraxane (Albumin-bound Paclitaxel) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Abraxane

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Abraxane

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ABRAXANE (albumin-bound paclitaxel) ® for Injectable Suspension
(paclitaxel protein-bound particles) for Injectable Suspension
(albumin-bound)

WARNING

ABRAXANE (albumin-bound paclitaxel) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

ABRAXANE (albumin-bound paclitaxel) therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm³. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE (albumin-bound paclitaxel) .

Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

DRUG DESCRIPTION

ABRAXANE (albumin-bound paclitaxel) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. Paclitaxel exists in the particles in a non-crystalline, amorphous state. ABRAXANE (albumin-bound paclitaxel) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. ABRAXANE (albumin-bound paclitaxel) is free of solvents.

The active agent in ABRAXANE (albumin-bound paclitaxel) ® is paclitaxel, a natural product with antitumor activity. Paclitaxel is obtained from Taxus media. The chemical name for paclitaxel is 5β,20-Epoxy-1,2α,4,7β,10β,13αhexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3phenylisoserine.

Paclitaxel has the following structural formula:

ABRAXANE® (paclitaxel) Structural Formula Illustration

Paclitaxel is a white to off-white crystalline powder with the empirical formula C₄₇H₅₁NO₁₄ and a molecular weight of 853.91. It is highly lipophilic, insoluble in water, and melts at approximately 216°C to 217°C.

What are the possible side effects of paclitaxel protein-bound (Abraxane)?

If you experience any of the following serious side effects from paclitaxel protein-bound, seek emergency medical attention or contact your doctor immediately:

an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection);
liver damage (abdominal pain, yellowing of the...

Read All Potential Side Effects and See Pictures of Abraxane »

What are the precautions when taking albumin-bound paclitaxel (Abraxane)?

Before using paclitaxel, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain 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...

Read All Potential Precautions of Abraxane »

Last reviewed on RxList: 7/8/2009
This monograph has been modified to include the generic and brand name in many instances.