Important Safety Information

Important Safety Information

WARNING – LOW WHITE BLOOD CELL COUNT (NEUTROPENIA)

  • Do not take ABRAXANE if your white blood cell count is below 1500 cells/mm3 (neutropenia), since you may be more likely to get a serious infection. While taking ABRAXANE, you must get regular blood tests to check for any problems that could develop
  • ABRAXANE contains albumin, a substance found in human blood. Do not substitute for or with other paclitaxel formulations

Who Should Not Receive ABRAXANE?

  • Do not receive ABRAXANE if:
    • your white blood cell count is below 1500 cells/mm3
    • you have had a severe allergic reaction to ABRAXANE

Serious Side Effects

  • ABRAXANE may cause serious side effects, including:
    • decreased blood counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cell important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment
    • numbness, tingling, pain, or weakness in the 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 (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE

Other Risks

  • Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered or withheld
  • ABRAXANE contains albumin (human), a product of human blood

Risks to Pregnancy

  • If you are pregnant or become pregnant, ABRAXANE can harm your unborn baby. You should not become pregnant while taking 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
  • If you are a man, you should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner

Other Possible Side Effects

  • The most common side effects of ABRAXANE include:
    • hair loss
    • numbness, tingling, pain, or weakness in the hands or feet
    • abnormal heart beat
    • 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 100.4ºF) or other signs of infection, tell your doctor right away
    • diarrhea
    • loss of body fluid (dehydration)
    • swelling in the hands or feet
  • Other side effects include vision problems, decreased appetite, kidney problems, constipation, and difficulty breathing
  • In some patients receiving ABRAXANE, severe heart and blood vessel side effects have occurred. These included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, high blood pressure, stroke, and heart failure

Other Important Safety Information about ABRAXANE

  • You should contact your doctor if you have signs or symptoms of vomiting, diarrhea, dehydration, cough, or breathing difficulties that do not go away, or signs of an allergic reaction. Tell your doctor if you have any other medical conditions
  • Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected
  • It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking
  • Since it is not known if ABRAXANE passes into human milk, you should discuss with your doctor if you should receive ABRAXANE or breastfeed
  • It is not known if ABRAXANE is safe or effective in children
  • ABRAXANE has not been adequately studied in people with severe kidney problems

These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Please see Patient Information, and full Prescribing Information including Boxed WARNING.

Please see Patient Information and full Prescribing Information, including Boxed WARNING.