Abraxane

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 5?,20-Epoxy-1,2?,4,7?,10?,13?hexahydroxytax-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 »


Abraxane Consumer (continued)

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 right away if you have any serious side effects, including: 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.

Get medical help right away 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. Get medical help right away 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.

PRECAUTIONS: 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 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 Patient Information Including Side Effects

Brand Names: Abraxane

Generic Name: paclitaxel protein-bound (Pronunciation: PAK li TAX el PRO teen-bound)

  • What is paclitaxel protein-bound (Abraxane)?
  • What are the possible side effects of paclitaxel protein-bound (Abraxane)?
  • What is the most important information I should know about paclitaxel protein-bound (Abraxane)?
  • What should I discuss with my healthcare provider before taking paclitaxel protein-bound (Abraxane)?
  • How should I use paclitaxel protein-bound (Abraxane)?
  • What happens if I miss a dose (Abraxane)?
  • What happens if I overdose (Abraxane)?
  • What should I avoid while using paclitaxel protein-bound (Abraxane)?
  • What other drugs will affect paclitaxel protein-bound (Abraxane)?
  • Where can I get more information?

What is paclitaxel protein-bound (Abraxane)?

Paclitaxel protein-bound is a cancer (antineoplastic) medication. Paclitaxel protein-bound interferes with the growth of cancer cells and slows their growth and spread in the body.

Paclitaxel protein-bound is used in the treatment breast cancer.

Paclitaxel protein-bound may also be used for purposes other than those listed in this medication guide.

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 skin or eyes); or
  • severe nausea, vomiting, or diarrhea;
  • numbness or tingling; or
  • irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue taking paclitaxel protein-bound and talk to your doctor if you experience:

  • tissue or vein reactions near the site of administration;
  • low red blood cell count;
  • joint or muscle pain;
  • sores in the mouth;
  • hair loss; or
  • mild to moderate nausea, vomiting, diarrhea, or loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about paclitaxel protein-bound (Abraxane)?

Paclitaxel protein-bound should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of paclitaxel protein-bound including: allergic reactions (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); numbness or tingling; irregular heartbeats; and others. Talk to your doctor about the possible side effects from treatment with paclitaxel protein-bound.

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