PATIENT INFORMATION

Paclitaxel Injection, USP

Read this patient information leaflet before you start taking paclitaxel. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about paclitaxel?

Paclitaxel can cause serious side effects including death.

Serious allergic reactions (anaphylaxis) can happen in people who receive paclitaxel injection.

Anaphylaxis is a serious medical emergency that can lead to death and must be treated right away.

Tell your healthcare provider right away if you have any of these signs of an allergic reaction:

• trouble breathing
• sudden swelling of your face, lips, tongue, throat, or trouble swallowing
• hives (raised bumps) or rash

Your healthcare provider will give you medicines to lessen your chance of having an allergic reaction.

What is paclitaxel?

Paclitaxel is a prescription medicine used to treat some forms of:

• ovarian cancer
• breast cancer
• lung cancer
• Kaposi’s sarcoma

It is not known if paclitaxel is safe or effective in children.

Who should not receive paclitaxel?

Do not receive paclitaxel if:

• you are allergic to any of the ingredients in paclitaxel. See the end of this leaflet for a complete list of ingredients in paclitaxel.
• are allergic to medicines containing Kolliphor ® ELP (Polyoxyl 35 Castor Oil, NF).
• you have low white blood cell counts.

What should I tell my healthcare provider before receiving paclitaxel?

Before receiving paclitaxel, tell your healthcare provider about all your medical conditions, including if you:

• have liver problems
• have heart problems
• are pregnant or plan to become pregnant. Paclitaxel can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breast-feed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive paclitaxel?

• Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider.

Your healthcare provider will do certain tests while you receive paclitaxel.

What are the possible side effects of paclitaxel?

Tell your healthcare provider right away if you have:

• severe stomach pain
• severe diarrhea

The most common side effects of paclitaxel injection include:

• low red blood cell count (anemia) feeling weak or tired
• hair loss
• numbness, tingling, or burning in your hands or feet (neuropathy)
• joint and muscle pain
• nausea and vomiting
• hypersensitivity reaction - trouble breathing; sudden swelling of your face, lips, tongue, throat, or trouble swallowing; hives (raised bumps) or rash
• diarrhea
• mouth or lip sores (mucositis)
• infections - if you have a fever (temperature above 100.4°F) or other sign of infection, tell your healthcare provider right away
• swelling of your hands, face, or feet
• bleeding events
• irritation at the injection site
• low blood pressure (hypotension)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of paclitaxel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Accord Healthcare Inc. at 1-866-941-7875.

General information about the safe and effective use of paclitaxel.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use paclitaxel for a condition for which it was not prescribed.

Do not give paclitaxel to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about paclitaxel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about paclitaxel that is written for health professionals. For more information call Accord Healthcare Inc. at 1-866-941-7875.

What are the ingredients in paclitaxel?

Active ingredient: Paclitaxel USP.

Inactive ingredients include:Kolliphor ® ELP (Polyoxyl 35 Castor Oil, NF) and dehydrated alcohol, USP.

What is cancer?

Under normal conditions, the cells in your body divide and grow in an orderly, controlled way. Cell division and growth are necessary for the human body to perform its functions and to repair itself, when necessary. Cancer cells are different from normal cells because they are not able to control their own growth. The reasons for this abnormal growth are not yet fully understood. A tumor is a mass of unhealthy cells that are dividing and growing fast and in an uncontrolled way. When a tumor invades surrounding healthy body tissue, it is known as a malignant tumor. A malignant tumor can spread (metastasize) from its original site to other parts of the body if not found and treated early.

Kolliphor ® is the registered trademark of BASF.

51 3618 0 703734

Revised: March 2017

Accord Healthcare, Inc.,

Durham, NC 27703, USA.