SAFETY AND EFFECTIVENESS OF ABRAXANE

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Prescribing Information Patient Information Important Safety Information MedWatch - report suspected adverse reactions

Side Effects of ABRAXANE

Those considering ABRAXANE should be aware that there are side effects associated with this treatment. However, it is not always possible to tell whether such effects are caused by ABRAXANE, the cancer itself, or another medication you may be taking.

Always talk to your doctor about any side effects you are experiencing.

Serious side effects were reported with ABRAXANE

ABRAXANE should not be taken by patients with low white blood cell counts

Infections due to low white blood cell count (neutropenia)

Among the body’s defenses against bacterial infections are white blood cells. ABRAXANE usually causes a brief drop in white blood cells, which may cause you to be more susceptible to infection and fever. Between ABRAXANE treatment cycles, blood tests are given to check the body’s white blood cell counts.

Call your doctor or nurse right away if you experience a fever over 100.4°F or notice any other signs of infection.

Numbness, tingling, or burning in the hands and/or feet (neuropathy)

These symptoms occur often with ABRAXANE, and usually get better or go away without medication within three weeks of interrupting treatment. Be sure to tell your doctor about any numbness, tingling, or burning that you have in your hands or feet so he or she can decide the best approach for relief of your symptoms. Sometimes it is necessary to interrupt treatment with ABRAXANE until these symptoms improve. After improvement, treatment can be restarted at a lower dose.

Talk with your doctor or nurse if you experience these side effects. They may find it necessary to adjust your dose of ABRAXANE.

Additional common side effects were reported with ABRAXANE

Hair loss

Complete hair loss almost always occurs with ABRAXANE. This usually involves the loss of eyebrows, eyelashes, and pubic hair, as well as scalp hair. It can occur suddenly after treatment has begun, but usually happens 14 to 21 days after treatment.

Hair usually grows back after ABRAXANE treatment is completed.

Fatigue and weakness

ABRAXANE may cause asthenia, fatigue, weakness, lethargy, and malaise. These side effects are usually self-limited and do not require dose modification or interruption.

Low red blood cell count

Anemia occurs when there are not enough red blood cells in your blood. It may make you feel tired, appear pale, and experience shortness of breath. Treatment with ABRAXANE may cause a decrease in red blood cell counts.

Call your doctor or nurse if you experience any of these symptoms. They can talk with you about further treatment for anemia.

Mouth or lip sores

Some people develop redness and/or sores in the mouth or on the lips. These symptoms might occur a few days after the ABRAXANE treatment and usually decrease or disappear within one week. Talk with your doctor about proper mouth care and other ways to prevent or reduce your chances of developing mucositis.

Joint and muscle pain

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

Stomach upset and diarrhea

Some people experience nausea, vomiting, and/or diarrhea following ABRAXANE use. If you experience nausea or stomach upset, tell your doctor or nurse, because medicines can be given that almost always reduce or eliminate these symptoms. Diarrhea will usually disappear without treatment.

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

Heart and blood vessel (cardiovascular) effects

ABRAXANE may cause a drop in heart rate and low blood pressure. The patient usually does not notice these changes. These changes usually do not require treatment. You should notify your doctor if you have a history of heart disease.

Irritation at the injection site

ABRAXANE may cause irritation at the site where it enters the vein. Reactions may include discomfort, redness, swelling, inflammation (of the surrounding skin or of the vein itself), and ulceration (open sores). These reactions are usually caused by the IV (intravenous) fluid leaking into the surrounding area.

If you notice anything unusual at the site of the injection needle, either during or after treatment, tell your doctor right away.

Ability to drive and use machinery

Side effects may affect your ability to drive and use machinery. Talk with your doctor or other healthcare providers to discuss ways to prevent or reduce some of these side effects.

Remember to report any unusual side effects to your doctor or nurse. This website does not include all possible side effects that can occur with ABRAXANE. Talk with your doctor about other possible side effects.

NEXT: Coping With Side Effects

ABRAXANE is a prescription medicine for breast cancer that has spread to other parts of the body. ABRAXANE is used after treatment with combination chemotherapy has stopped working, including anthracyclines, if appropriate, or when the cancer has come back within 6 months of treatment after surgery.

Important Safety Information About ABRAXANE®

WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) should be given only by a doctor who is experienced in giving chemotherapy. That way, if any problems come up during treatment, your doctor will be able to manage them.

If you have a low white blood cell count (neutropenia), you should not take ABRAXANE, 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. Albumin can affect the way other drugs work.

  • ABRAXANE has not been studied in people with kidney problems
  • If you are pregnant, or become pregnant, ABRAXANE can cause harm to your unborn baby. You should avoid becoming pregnant while taking ABRAXANE
  • Men should not father a child while being treated with ABRAXANE
  • If you have a very low white blood cell count, you should not take ABRAXANE. If your white blood cell count goes down while taking ABRAXANE, you should stop taking it until your white blood cell count returns to normal. If your white blood cell count drops very low, your doctor will lower your dose of ABRAXANE
  • It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines you are taking
  • People treated with ABRAXANE often have a side effect called sensory neuropathy, a numbness, tingling, or burning in the hands, feet, and ankles. If you get mild sensory neuropathy, you will probably not have to lower your dose of ABRAXANE. If sensory neuropathy becomes severe, you may have to stop taking ABRAXANE until it improves, and then continue treatment at a lower dose
  • Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered
  • Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). When taking ABRAXANE, you should be monitored by your doctor or nurse to make sure no problems occur at the injection site
  • Since it is not known if ABRAXANE passes into human milk, you should stop nursing if you are taking ABRAXANE
  • You should not drive a car when you are being treated with ABRAXANE. Side effects such as feeling very tired (fatigue), having no energy (lethargy), or feeling sick (malaise) can affect your ability to drive or use machinery
  • In a clinical trial, severe heart and blood vessel side effects occurred in approximately 3% of women taking ABRAXANE. Side effects included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, and high blood pressure. Stroke and heart failure were rare
  • The most important side effects during treatment with ABRAXANE included hair loss, low white blood cell count, sensory neuropathy, weakness, muscle or joint pain, low red blood cell count (anemia), nausea, diarrhea, infection, vomiting, and sores in the mouth or on the lips (mucositis)
  • Other side effects included vision problems, kidney problems, fluid retention, liver problems, and allergic reactions, and a decrease in blood clotting cells (platelets). Dehydration and fever were common

Please see full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.

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