Paclitaxel (with polyoxyethylated castor oil) Injection

(pak'' li tax' el)

Brand Name(s): Taxol^®¶; also available generically

IMPORTANT WARNING:

Paclitaxel (with polyoxyethylated castor oil) injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Paclitaxel (with polyoxyethylated castor oil) 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 (with polyoxyethylated castor oil) 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 (with polyoxyethylated castor oil) injection.

Paclitaxel (with polyoxyethylated castor oil) injection may cause serious or life-threatening allergic reactions. You will receive certain medications to help prevent an allergic reaction before you receive each dose of the medication. 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 (with polyoxyethylated castor oil).

Talk to your doctor about the risks of receiving paclitaxel (with polyoxyethylated castor oil) injection.

WHY is this medicine prescribed?

Paclitaxel (with polyoxyethylated castor oil) is used along or along with other chemotherapy medications to treat breast cancer, ovarian cancer (cancer that begins in the female reproductive organs where eggs are formed), and non-small cell lung cancer (NSCLC). Paclitaxel (with polyoxyethylated castor oil) injection is also used to treat Kaposi's sarcoma (a type of cancer that causes patches of abnormal tissue to grow under the skin) in people who have acquired immunodeficiency syndrome (AIDS). Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of cancer cells.

Are there OTHER USES for this medicine?

Paclitaxel injection is also sometimes used to treat cancer of the head and neck, esophagus (tube that connects the mouth and stomach), bladder, endometrium (lining of the uterus), and cervix (opening of the uterus). Talk to your doctor about the risks of using this medication for your condition.

HOW should this medicine be used?

Paclitaxel (with polyoxyethylated castor oil) injection comes as a liquid to be injected over 3 or 24 hours intravenously by a doctor or nurse in a hospital or clinic. When paclitaxel (with polyoxyethylated castor oil) is used to treat breast cancer, ovarian cancer, or non-small cell lung cancer it is usually given once every 3 weeks. When paclitaxel (with polyoxyethylated castor oil) is used to treat Kaposi's sarcoma, it may be given once every 2 or 3 weeks.

Your doctor may need to interrupt your treatment, reduce your dose, or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving paclitaxel (with polyoxyethylated castor oil) injection,

• tell your doctor and pharmacist if you are allergic to paclitaxel, docetaxel, any other medications, polyoxyethylated castor oil (Cremophor EL), or medications that contain polyoxyethylated castor oil such as cyclosporine injection (Sandimmune) or teniposide (Vumon). Ask your doctor or pharmacist if you do not know if a medication that you are allergic to contains polyoxyethylated castor oil.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: buspirone (Buspar); carbamazepine (Carbatrol, Equetro, Tegretol); certain medications used to treat human immunodeficiency virus (HIV) such as atazanavir (Reyataz, in Evotaz); indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in in Viekira Pak), and saquinavir (Invirase); clarithromycin (Biaxin, in Prevpac); eletriptan (Relpax); felodipine; gemfibrozil (Lopid); itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); lovastatin (Altoprev); midazolam; nefazodone; phenobarbital; phenytoin (Dilantin, Phenytek); repaglinide (Prandin, in Prandimet); rifampin (Rimactane, Rifadin, in Rifamate, in Rifater); rosiglitazone (Avandia, in Avandaryl, in Avandamet); sildenafil (Revatio, Viagra); simvastatin (Flolipid, Zocor, in Vytorin); telithromycin (Ketek; not available in the U.S.), and triazolam (Halcion); Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with paclitaxel, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had liver or heart disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving paclitaxel (with polyoxyethylated castor oil) injection. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while receiving paclitaxel (with polyoxyethylated castor oil) injection, call your doctor. Paclitaxel injection may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breast-feed while you are receiving paclitaxel (with polyoxyethylated castor oil) injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Paclitaxel (with polyoxyethylated castor oil) may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, swelling, or sores in the place where the medication was injected
• numbness, burning, or tingling in the hands or feet
• muscle or joint pain
• nausea
• vomiting
• diarrhea
• sores in the mouth or on the lips
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• shortness of breath
• pale skin
• excessive tiredness
• unusual bruising or bleeding
• chest pain
• slow or irregular heartbeat

Paclitaxel (with polyoxyethylated castor oil) may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• pale skin
• shortness of breath
• excessive tiredness
• sore throat, fever, chills, and other signs of infection
• unusual bruising or bleeding
• numbness, burning, or tingling of the hands and feet
• sores in the mouth

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2020.