Paclitaxel

Paclitaxel is a prescription medication used to treat cancer, including ovarian, breast, and lung, pancreatic cancer, and Kaposi's sarcoma. Paclitaxel belongs to a group of drugs called antimicrotubule agents or taxanes. It works by stopping the growth and spread of cancer cells.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.

Common side effects of paclitaxel include low blood cell count, hair loss, and joint or muscle pain.

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

• ovarian cancer
• breast cancer
• lung cancer
• pancreatic cancer
• Kaposi’s sarcoma: cancer that causes patches of abnormal tissue growth under the skin, in the nose, in the lining of the mouth, in the throat, or in other organs

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Paclitaxel may be found in some form under the following brand names:

• Abraxane

• Onxol

• Taxol

The most common side effects of paclitaxel 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)

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• midazolam
• buspirone
• felodipine
• lovastatin
• eletriptan
• sildenafil
• simvastatin
• triazolam
• atazanavir
• clarithromycin
• indinavir
• itraconazole
• ketoconazole
• nefazodone
• nelfinavir
• ritonavir
• saquinavir
• telithromycin
• rifampin
• carbamazepine
• repaglinide
• rosiglitazone
• gemfibrozil

Paclitaxel injection may cause a large decrease in the number of white blood cells (a type of blood cell that is needed to fight infection) in your blood. This increases the risk that you will develop a serious infection. You should not receive paclitaxel if you already have a low number of white blood cells. Your doctor will order laboratory tests before and during your treatment to check the number of white blood cells in your blood. Your doctor will delay or interrupt your treatment if the number of white blood cells is too low. Call your doctor immediately if you develop a temperature greater than 100.4 °F (38 °C); a sore throat; cough; chills; difficult, frequent, or painful urination; or other signs of infection during your treatment with paclitaxel injection.

Paclitaxel injection is manufactured with additional ingredients to allow the medication to reach parts of the body where it is needed. One form of paclitaxel injection (Abraxane) is manufactured with human albumin, and the other form of paclitaxel injection (Onxol, Taxol) is manufactured with a solvent called polyoxyethylated castor oil. There are important differences between the two forms of paclitaxel, so these products should not be substituted for each other.

If you are using the form of paclitaxel injection that is manufactured with polyoxyethylated castor oil, you may experience a serious or life-threatening allergic reaction. You will receive certain medications to help prevent an allergic reaction before you receive each dose of paclitaxel. Tell your doctor if you experience any of the following symptoms of an allergic reaction: rash; hives; itching; swelling of the eyes, face, throat, lips, tongue, hands, arms, feet, or ankles; difficulty breathing or swallowing; flushing; fast heartbeat; dizziness; or fainting.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to paclitaxel injection.

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 polyoxyl 35 castor oil, NF.
• you have low white blood cell counts.

Grapefruit and grapefruit juice may interact with paclitaxel and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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 breastfeeding or plan to breastfeed. It is not known if paclitaxel passes into your breast milk. You and your healthcare provider should decide if you will receive paclitaxel or breastfeed.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if paclitaxel passes into your breast milk. You and your doctor should decide if you will receive paclitaxel or breastfeed.

Paclitaxel is injected into a vein (intravenous [IV] infusion) by your healthcare provider. It may be given once every 3 weeks. For the treatment of Kaposi's Sarcoma, paclitaxel may be given every 2 or 3 weeks.

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

The following paclitaxel regimens are recommended:

• For previously untreated patients with cancer of the ovary, paclitaxel is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor.
• In patients previously treated with chemotherapy, paclitaxel is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor.
• For patients with cancer of the breast, paclitaxel is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor.
• For patients with non-small cell lung carcinoma, paclitaxel is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor.
• For patients with advanced pancreatic cancer, paclitaxel is typically given on days 1, 8, and 15 of each 28-day cycle. The actual dose and total length of therapy will be determined by your doctor.
• For patients with AIDS-related Kaposi’s sarcoma, paclitaxel is typically given every 3 weeks. The actual dose and total length of therapy will be determined by your doctor.

Paclitaxel is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Ask your doctor or pharmacist if you have any questions about paclitaxel.

WARNING:

Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.

Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel.