What side effects may I experience?

These are not all of the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist.

The most common side effects include:

Hair loss

It is very likely that you will lose your hair when you take ABRAXANE. This may involve the loss of eyebrows, eyelashes, and pubic hair, as well as the hair on your head. It can occur shortly after treatment has begun. Hair usually grows back after ABRAXANE treatment is completed.

Numbness, tingling, pain, or weakness in the hands or feet (neuropathy)

ABRAXANE may cause numbness, tingling, pain, or weakness, usually in your hands or feet.

Abnormal heartbeat

ABRAXANE may cause your heart to beat a little faster or slower than it normally does.

Tiredness/fatigue

Make sure you get plenty of rest throughout your treatment. Talk to your doctor or nurse about ways to keep your energy level from decreasing too much during treatment. Tiredness is likely to improve once your treatment is over.

Joint and muscle pain

You may get joint and muscle pain a few days after your ABRAXANE treatment. These symptoms may disappear in a few days. Although pain medicine may not be necessary, tell your doctor or nurse if you are uncomfortable.

Changes in liver function

ABRAXANE may affect your liver. If this occurs, your skin or the whites of your eyes may look yellow, or you may notice a darker color of your urine. If you already have liver problems before starting treatment, your doctor may reduce the amount of ABRAXANE that you receive.

Rash

ABRAXANE may cause rashes to appear on your skin. If the rash causes any discomfort, your doctor may prescribe a medication or give you other ideas to help with this.

Low red blood cell count (anemia)

Red blood cells carry oxygen to most parts of your body. Having too few red blood cells to carry the oxygen in your body is known as anemia. Anemia may make you feel tired, appear pale, and experience shortness of breath. Be sure to talk to a member of your healthcare team if you experience any of these symptoms.

Nausea and vomiting

If you experience any nausea (feeling sick to your stomach) during or after you have received ABRAXANE, tell your doctor or nurse. Your doctor may prescribe a medicine that can help reduce these side effects.

Infections

ABRAXANE can cause a drop in the number of white blood cells in your bloodstream, which may cause you to be more susceptible to infection and fever. If you have a fever (temperature of greater than 100.4°F) or other signs of infection, tell your doctor right away.

Diarrhea

If you experience severe abdominal or stomach area pain and/or severe diarrhea, tell your doctor right away.

Loss of body fluid (dehydration)

ABRAXANE may cause a loss of body fluid, which is also called dehydration. Ask your doctor or nurse how much fluid you should drink each day in order to stay hydrated.

Swelling in the hands or feet

ABRAXANE may cause your hands or feet to swell. If you notice any swelling in your hands or feet while receiving treatment with ABRAXANE, you should contact your doctor.

Indications PLURAL

Important Safety Information About ABRAXANE

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
  • Do not receive ABRAXANE if:
    • your white blood cell count is below 1500 cells/mm3
    • you have had a severe allergic reaction to ABRAXANE
  • 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)
    • allergic (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE
  • 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
  • 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

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
  • 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 studied in people with kidney problems

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