cpsABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.

Important Safety Information

Serious Side Effects

ABRAXANE may cause serious side effects, including:
  • Decreased blood cell counts. ABRAXANE can cause a severe decrease in neutrophils, a type of white blood cell which helps fight infections, and blood cells called platelets which help to clot blood. Your healthcare provider will check your blood cell count during your treatment with ABRAXANE
  • Nerve problems (neuropathy). Tell your healthcare provider if you have numbness, tingling, pain, or weakness in your hands or feet
  • Severe infection (sepsis). If you receive ABRAXANE in combination with gemcitabine, infections can be severe and lead to death. Tell your healthcare provider right away if you have a fever (temperature 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 healthcare provider right away if you suddenly get a dry cough that will not go away or shortness of breath
  • Allergic reactions. Severe allergic reactions are medical emergencies that can happen in people who receive ABRAXANE and can lead to death. You may have an increased risk of having an allergic reaction to ABRAXANE if you are allergic to other taxane medicines. Your healthcare provider will monitor you closely for allergic reactions during your infusion of ABRAXANE. Tell your healthcare provider right away if you get any of these signs of a serious allergic reaction: trouble breathing, sudden swelling of your face, lips, tongue, throat, or trouble swallowing, hives (raised bumps), rash, or redness all over your body

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
  • Do not breastfeed during your treatment and for two weeks after the last dose of ABRAXANE

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 in people with breast cancer include:
    • hair loss
    • numbness, tingling, pain, or weakness in the hands or feet
    • tiredness
    • changes in your liver function tests
    • nausea
    • diarrhea
    • infections
    • decreased white blood cell count
    • abnormal heartbeat
    • joint and muscle pain
    • low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your healthcare provider if you feel weak, tired, or short of breath
  • 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
  • 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 full Patient Information and Prescribing Information, including Boxed WARNING.