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Important Safety Information ABOUT ABRAXANE

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

• Severe 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
• Severe 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
• Severe 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. Your healthcare provider will check to see if you are pregnant before you start treatment with ABRAXANE. Women should not become pregnant and should use effective birth control (contraception) during treatment and for at least six months after the last dose of ABRAXANE. Talk to your doctor about birth control methods you can use during this time
• ABRAXANE can harm the unborn baby of your partner
• If you are a man, you should not father a child and should use effective birth control (contraception) during treatment and for at least three months after the last dose of ABRAXANE
• ABRAXANE may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you

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
• The most common side effects of ABRAXANE in people with non–small cell lung cancer include:
  • low red blood cell count (anemia)
  • decreased platelet cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • tiredness
  • decreased white blood cell count
  • hair loss
  • nausea
• The most common side effects of ABRAXANE in people with pancreatic cancer include:
  • decreased white blood cell count
  • numbness, tingling, pain, or weakness in the hands or feet
  • hair loss
  • diarrhea
  • vomiting
  • rash
  • tiredness
  • nausea
  • swelling in the hands or feet
  • fever
  • decreased appetite
  • signs of dehydration including, thirst, dry mouth, dark yellow urine, decreased urine, headache, or muscle cramps

• 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
• The safety and effectiveness in children have not been shown
• 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.

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