Onxol

Onxol is a prescription medication used to treat advanced breast and ovarian cancers when other treatments have failed. Onxol belongs to a group of drugs called antimicrotubule agents or taxanes. These work to treat advanced breast and ovarian cancers by preventing the growth and spread of cancerous cells within the body.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare provider, typically every three weeks.

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

Onxol is a prescription medication used to treat advanced ovarian cancer and advanced metastatic breast cancer when other treatments have failed.

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

• Ivax Pharmaceuticals, Inc.

Serious side effects have been reported with Onxol. See the “Onxol Precautions” section.

Common side effects of Onxol include the following:

• low blood cell counts
• feeling weak or tired
• hair loss
• numbness, tingling, and/or burning in your hands and/or feet (neuropathy)
• joint and/or muscle pain
• nausea
• diarrhea
• swelling of your hands, face, and/or feet
• irritation at the injection site

This is not a complete list of Onxol 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:

• live vaccines; if you are unsure which vaccines fall into this category, consult with your pharmacist
• other chemotherapy medications; if you are unsure which medications fall into this category, consult with your pharmacist
• immunosuppressant medications; if you are unsure of which medications fall into this category, consult with your pharmacist
• cisplatin
• 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 Onxol drug interactions. Ask your doctor or pharmacist for more information. 

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

• Large decreases in the number of white blood cells in your blood. This increases the risk that you will develop a serious infection. You should not receive Onxol 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, and/or painful urination
• Severe allergic reactions. Onxol is manufactured with polyoxyethylated castor oil, you may experience a serious or life-threatening allergic reaction. You will receive medications to help prevent an allergic reaction before you receive each dose of Onxol. Tell your doctor if you experience any of the following symptoms of an allergic reaction:
  • itching
  • sudden difficulty breathing
  • sudden and abnormal swelling of the lips, tongue, and/or throat
  • sudden onset red blister-like skin rash
  • flushing
  • fast heartbeat
  • a sudden drop in blood pressure
  • dizziness
  • fainting
• Low blood pressure, high blood pressure, and/or abnormally slow heart rate during infusion. Occasionally, low blood pressure, high blood pressure, and/or abnormally slow heart rates are reported during infusions of Onxol. Be sure to inform your physician if you have any blood pressure or heart rhythm disorders before beginning treatment with Onxol.
• Injection site reactions. Injection site reactions ranging in severity from mild to severe have been known to occur with infusions of Onxol. Reported symptoms have included skin redness, tenderness, discoloration, and/or swelling at the injection site. Severe reactions may occur if Onxol is accidentally injected under the skin instead of into a vein. Your physician will monitor you during your infusion to ensure that these reactions are treated if they occur.

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

Do not receive Onxol if:

• you are allergic to any of the ingredients in Onxol
• are allergic to medicines containing polyoxyl 35 castor oil
• you have low white blood cell counts

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

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

• are allergic to Onxol or to any of its ingredients
• have liver problems
• have any type of anemia or other medical condition that causes you to have low blood cell counts
• have or suspect you may have any type of infection; symptoms of infections include, but are not limited to: fever, cough, difficult or painful urination, chills, and/or sore throat
• have low or high blood pressure
• have had injection-site reactions with injected medications in the past
• have AIDS or HIV
• are pregnant or plan to become pregnant
• are breastfeeding or plan to 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 pregnant 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 Onxol crosses into human 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. Your doctor and you will decide if the benefits outweigh the risk of using Onxol.

• Take Onxol exactly as prescribed.
• Onxol is available in an injectable form to be given directly into a vein (IV) by a healthcare provider, typically every three weeks.
• Before you are given Onxol, you will have to take certain medicines (premedications) to prevent or reduce the chance you will have a serious allergic reaction. Such reactions have occurred in a small number of patients while receiving Onxol and have been rarely fatal.
• If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue Onxol. Ask your doctor or pharmacist for ways to lessen these effects.
• If you get Onxol on your skin, rinse the area thoroughly with soap and water. If you get this medicine in your eyes, nose, or mouth, flush the area thoroughly with water.
• Check with your doctor before having immunizations (vaccinations) while you are receiving Onxol.
• If you miss a dose, receive the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and receive your next dose at the regular time. Do not receive two doses of Onxol at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose range of Onxol for the treatment of advanced ovarian cancer when other treatments have failed is 135 mg - 175 mg per square meter of body surface area injected intravenously over three hours, typically every three weeks.

The recommended dose of Onxol for the treatment of advanced metastatic breast cancer when other treatments have failed is 175 mg per square meter of body surface area injected intravenously over three hours, typically every three weeks.

Onxol 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.

This medication will be stored and kept by a healthcare professional.

Onxol should only 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 dofficulty breathing, low blood pressure requiring treatment, angioedema, and generalized hives have occurred in 2 to 4% of patients receiving Onxol in clinical trials. Fatal reactions have also occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists prior to initiating Onxol therapy. Patients who experience severe hypersensitivity reactions to Onxol should not be rechallenged with the drug.

Onxol therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1,000 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in serious life-threatening infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving Onxol.