Paclitaxel protein-bound is used to treat advanced cancer of the breast, lung, or pancreas. paclitaxel protein-bound is used when the cancer cannot be treated with surgery or after other treatments have failed.

Paclitaxel protein-bound is sometimes given with other cancer medicines.

Paclitaxel protein-bound may also be used for purposes not listed in this medication guide.

You should not be treated with paclitaxel protein-bound if you have a very low white blood cell count.

Paclitaxel protein-bound is given as an infusion into a vein. A healthcare provider will give you this injection.

For breast cancer, paclitaxel protein-bound 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 paclitaxel protein-bound is injected.

You may need frequent medical tests to be sure this medicine 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 this medicine if you are allergic to paclitaxel, or if you have:

• a low white blood cell count; or

• severe liver disease.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease; or

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

Paclitaxel protein-bound can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use paclitaxel protein-bound 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 paclitaxel protein-bound.

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 paclitaxel protein-bound can harm an unborn baby.

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

Paclitaxel protein-bound 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 paclitaxel protein-bound injection.

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

Paclitaxel protein-bound 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.

Get emergency medical help if you have signs of an allergic reaction (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).

Paclitaxel protein-bound may cause serious side effects. 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 side effects of paclitaxel protein-bound may include:

• fever, chills, or other signs of infection;

• bruising, bleeding, anemia;

• numbness, tingling, or swelling in your hands or feet;

• hair loss, rash;

• nausea, vomiting, diarrhea, loss of appetite;

• irregular heartbeats;

• feeling tired;

• muscle and joint pain;

• 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 affect paclitaxel protein-bound, 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.