Abraxane is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Abraxane is used to treat advanced cancer of the breast, lung, or pancreas. This medicine is used when he cancer cannot be treated with surgery or after other treatments have failed.

Abraxane is sometimes given with other cancer medicines.

You should not be treated with Abraxane if you have a very low white blood cell count.

You may need frequent medical tests at your doctor's office to be sure paclitaxel is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Abraxane can weaken your immune system. Your blood may need to be tested often.

Before taking this medicine

You should not be treated with Abraxane if you are allergic to paclitaxel, or if you have:

• a low white blood cell count; or

• severe liver disease.

To make sure Abraxane is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• an allergic reaction to medicines like paclitaxel (such as cabazitaxel or docetaxel).

Abraxane can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Abraxane if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Abraxane.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Abraxane can harm an unborn baby.

Do not breast-feed while you are receiving this medicine, and for at least 2 weeks after your last dose.

Abraxane is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Abraxane is given as an infusion into a vein. A healthcare provider will give you this injection.

For breast cancer, this medicine is usually given once every 3 weeks.

For cancer of the lung or pancreas, this medicine is given in a 21-day or 28-day treatment cycle. You will receive this medicine only on certain days of each cycle.

Your doctor will determine how long to treat you with this medicine.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Abraxane is injected.

You may need frequent medical tests to be sure Abraxane is not causing harmful effects. Your cancer treatments may be delayed based on the results.

You may be given other medication to help prevent an allergic reaction. Keep using this medication for as long as your doctor has prescribed.

Usual Adult Dose for Breast Cancer:

260 mg/m2 IV over 30 minutes every 3 weeks

Use: For metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless clinically contraindicated

Usual Adult Dose for Non-Small Cell Lung Cancer:

100 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after paclitaxel protein-bound

Use: For locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

Usual Adult Dose for Pancreatic Cancer:

125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine immediately after paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle

Use: For metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

You should not be treated with Abraxane if you are allergic to paclitaxel, or if you have:

• a low white blood cell count; or

• severe liver disease.

To make sure Abraxane is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• an allergic reaction to medicines like paclitaxel (such as cabazitaxel or docetaxel).

Abraxane can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Abraxane if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Abraxane.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Abraxane can harm an unborn baby.

Do not breast-feed while you are receiving this medicine, and for at least 2 weeks after your last dose.

Abraxane is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Call your doctor for instructions if you miss an appointment for your Abraxane injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Paclitaxel can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water.

Paclitaxel can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Abraxane (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• numbness, tingling, pain, or weakness in your hands or feet;

• sudden chest pain or discomfort, rapid heart rate;

• dry cough, shortness of breath, rapid and shallow breathing;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• dehydration symptoms - headache, muscle pain, thirst, dry mouth, hot and dry skin, vomiting, diarrhea, dark urine, being unable to urinate; or

• a blood infection (sepsis) - fever, flu symptoms, mouth and throat ulcers, rapid heart rate, shallow breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Abraxane side effects may include:

• fever, chills, or other signs of infection;

• bruising, bleeding, anemia;

• hair loss, rash;

• nausea, vomiting, diarrhea, loss of appetite;

• irregular heartbeats;

• feeling tired;

• muscle and joint pain;

• swelling in your hands or feet;

• abnormal liver function tests; or

• dehydration.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with paclitaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.