Taxol

Taxol is a prescription medication used to treat cancer, including ovarian, breast, and lung cancer, and Kaposi's sarcoma. Taxol belongs to a group of drugs called 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 Taxol include low blood cell count, hair loss, and joint or muscle pain.

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

• advanced ovarian cancer
• breast cancer. It can also be given after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. 
• nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. 
• 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.

• Bristol-Myers Squibb Company

• HQ SPCLT Pharma

The most common side effects of Taxol 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

This is not a complete list of Taxol drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Taxol including the following:

• 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 Taxol 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 have all or some of the following symptoms:
  • temperature greater than 100.4 °F (38 °C)
  • sore throat
  • cough
  • chills
  • difficult, frequent, or painful urination
• Anaphylaxis and severe hypersensitivity reactions. Tell your healthcare provider if you experience all or some of the following symptoms:
  • difficulty breathing
  • low blood pressure
  • hives or rash
  • swelling of face, lips, tongue, throat, or trouble swallowing
• Tell your healthcare provider right away if you experience:
  • severe stomach pain
  • severe diarrhea
• Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to Taxol.

Do not receive Taxol if:

• you are allergic to any of the ingredients in Taxol. 
• are allergic to other medicines formulated in Cremophor® EL (polyoxyethylated castor oil). 
• you have low white blood cell counts.

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

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

• are allergic to Taxol or any of its ingredients
• have liver problems
• have heart problems
• are pregnant or plan to become pregnant. Taxol 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 Taxol passes into your breast milk. You and your healthcare provider should decide if you will receive Taxol 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. No well-controlled studies have been done in humans. Based on its mechanism of action and findings in animals, Taxol can harm your unborn baby. You should not become pregnant while receiving Taxol. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving Taxol.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Taxol passes into your breast milk. It is not known if Taxol passes into your breast milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You and your doctor should decide if you will receive Taxol or breastfeed.

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

Your doctor will prescribe Taxol in an amount that is right for you.

Your doctor may prescribe medication before receiving Taxol to prevent allergic reactions. 

Your doctor should do regular blood tests while you receive Taxol.

The actual dose and total length of therapy will be determined by your doctor.

• For previously untreated patients with ovarian cancer: Taxol is typically given every 3 weeks at either of the following doses:
  • Taxol administered in a vein (IV) over 3 hours at a dose of 175 mg/m² followed by cisplatin at a dose of 75 mg/m²
  • Taxol administered in a vein (IV) over 24 hours at a dose of 135 mg/m² followed by cisplatin at a dose of 75 mg/m².
• In patients previously treated with chemotherapy for ovarian cancer, Taxol is typically given every 3 weeks. The recommended dose is Taxol 135 mg/m² or 175 mg/m² administered in a vein (IV) over 3 hours.
• For patients with breast cancer: Taxol is typically given every 3 weeks. The recommended dose of Taxol is 175 mg/m² in a vein (IV) over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy.
• For patients with non-small cell lung cancer, Taxol is typically given every 3 weeks. The recommended dose of Taxol is administered in a vein (IV) over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75 mg/m².
• For patients with AIDS-related Kaposi’s sarcoma, Taxol is typically given every 3 weeks. The recommended dose is:
  • Taxol administered at a dose of 135 mg/m² given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m² given intravenously over 3 hours every 2 weeks.

Taxol 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.

WARNING:

Taxol 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 Taxol should not be rechallenged with the drug.

Taxol 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 Taxol.