Abraxane

Abraxane is a prescription medication used to treat cancer, including breast, and lung, pancreatic cancer. Abraxane belongs to a group of drugs called antimicrotubule agents or taxanes. It works by stopping the growth and spread of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.

Common side effects of Abraxane include low blood cell count, hair loss, and joint or muscle pain.

Abraxane is a prescription medicine used to treat some forms of cancer including:

• advanced breast cancer in people who have already received certain other medicines for their cancer.
• advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation.
• advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Abraxis BioScience, LLC

The most common side effects of Abraxane include:

• hair loss
• numbness, tingling, pain, or weakness in the hands or feet
• abnormal heartbeat
• tiredness
• joint and muscle pain
• changes in your liver function tests
• rash
• low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your doctor if you feel weak, tired or short of breath.
• nausea and vomiting
• infections. If you have a fever (temperature of greater than 100.4° F) or other signs of infection, tell your doctor right away.
• Diarrhea
• Loss of body fluid (dehydration)
• Swelling in the hands or feet

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• midazolam
• buspirone
• felodipine
• lovastatin
• eletriptan
• sildenafil
• simvastatin
• triazolam
• atazanavir
• clarithromycin
• efavirenz
• cimetidine
• erythromycin
• fluoxetine
• nevirapine
• indinavir
• itraconazole
• ketoconazole
• nefazodone
• nelfinavir
• ritonavir
• saquinavir
• telithromycin
• rifampin
• carbamazepine
• phenytoin
• repaglinide
• rosiglitazone
• gemfibrozil

This is not a complete list of Abraxane drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Abraxane including the following:

• decreased blood cell counts. This increases the risk that you will develop a serious infection. You should not receive Abraxane if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood. Your doctor will delay or interrupt your treatment if the number of white blood cells is too low. Call your doctor immediately if you develop all or some of the following symptoms:
  • temperature greater than 100.4 °F (38 °C)
  • sore throat
  • cough
  • chills
  • difficult, frequent, or painful urination
• numbness, tingling, pain, or weakness in your hands or feet (neuropathy)
• severe infection (sepsis). If you receive Abraxane in combination with gemcitabine, infections can be severe and lead to death. Tell your doctor right away if you have a fever (temperature of greater than 100.4° F) or develop signs of infection.
• lung or breathing problems. If you receive Abraxane in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath.
• allergic reactions. Allergic reactions to Abraxane may be severe and can lead to death.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to Abraxane injection.

Do not receive Abraxane if:

• you are allergic to any of the ingredients in Abraxane. 
• you have low white blood cell counts.

Grapefruit and grapefruit juice may interact with Abraxane and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before receiving Abraxane, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to Abraxane or any of its ingredients
• have liver or kidney problems.
• have any other medical conditions.
• are a man planning to father a child. You should not father a child during your treatment with Abraxane. Abraxane can harm the unborn baby of your partner. Talk to your doctor if this is a concern to you.
• are pregnant or plan to become pregnant. Abraxane can harm your unborn baby. You should not become pregnant while receiving Abraxane. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving Abraxane.
• are breastfeeding or plan to breastfeed. It is not known if Abraxane passes into your breast milk. You and your doctor should decide if you will receive Abraxane or breastfeed.

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.

This medication falls into category D. No well-controlled studies have been done in humans. Based on its mechanism of action and findings in animals, Abraxane can harm your unborn baby. You should not become pregnant while receiving Abraxane. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving Abraxane.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Abraxane passes into your breast 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. You and your doctor should decide if you will receive Abraxane or breastfeed.

• Your doctor will prescribe Abraxane in an amount that is right for you.
• Premedication to prevent allergic reactions is generally not needed to receive Abraxane. Premedication may be needed if you have had an allergic reaction to Abraxane. In case of severe allergic reaction, Abraxane should not be used again.
• Abraxane will be given to you by intravenous infusion into your vein.
• Your doctor should do regular blood tests while you receive Abraxane.

The following Abraxane regimens are recommended:

• Breast cancer: Abraxane (paclitaxel) is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane is 260 mg/m2 administered in a vein (IV) over 30 minutes every 3 weeks.
• Non-small cell lung cancer: Abraxane (paclitaxel) is typically given on days 1, 8, and 15 of each 21-day cycle. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane is 100 mg/m2 administered in a vein (IV) over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin should be administered on Day 1 of each 21 day cycle immediately after Abraxane.
• Advanced pancreatic cancer: Abraxane (paclitaxel) is typically given on days 1, 8, and 15 of each 28 day cycle. The actual dose and total length of therapy will be determined by your doctor, but the recommended dose is Abraxane 125 mg/m2 administered in a vein (IV) over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle. Gemcitabine should be administered immediately after Abraxane on Days 1, 8 and 15 of each 28-day cycle.

Abraxane 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:

Abraxane 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.

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving Abraxane in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions to Abraxane should not be rechallenged with the drug.

Abraxane therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 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.