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Generic Name: paclitaxel (PAK-li-TAX-el)
Brand Name: Generic only. No brands available.

Onxol must be administered in an appropriate medical setting. Serious allergic reactions, some fatal, have occurred with the use of Onxol. DO NOT use Onxol again if you have experienced a severe allergic reaction to it. Stop using Onxol and notify your doctor immediately if you develop signs of an allergic reaction, such as rash; itching; fainting; severe dizziness or light-headedness; swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.

Certain patients with solid tumors or AIDS-related Kaposi sarcoma should not use Onxol. Frequent blood tests should be performed while you are using Onxol because of the risk of bone marrow suppression and serious infection.

Do not substitute or interchange Onxol with other forms of paclitaxel.

Onxol is used for:

Treating certain types of ovarian, lung, or breast cancer in certain patients. It is also used to treat AIDS-related Kaposi sarcoma in certain patients. It may also be used for other types of cancers as determined by your doctor.

Onxol is a chemotherapy medicine. It works by slowing or stopping cancer cells from dividing and growing, so they eventually die.

Do NOT use Onxol if:

  • you are allergic to any ingredient in Onxol or medicines that contain polyoxyethylated castor oil (eg, cyclosporine injection, teniposide injection)
  • you have extremely low white blood cell counts (eg, extremely low neutrophil counts)
  • you have shingles or chickenpox
  • you have taken or will be taking palifermin within 24 hours before or after using Onxol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Onxol:

Some medical conditions may interact with Onxol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a bacterial or viral infection, or HIV infection
  • if you have a history of a heart attack or other heart problems (eg, irregular heartbeat), high or low blood pressure, liver or kidney problems, bone marrow problems, or blood problems (eg, low blood platelet or neutrophil counts)
  • if you are undergoing radiation therapy
  • if you have ever had an allergic reaction to an insect sting

Some MEDICINES MAY INTERACT with Onxol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
  • Azole antifungals (eg, itraconazole, ketoconazole), benzodiazepines (eg, midazolam, triazolam), buspirone, cimetidine, cisplatin, eletriptan, felodipine, fluoxetine, gemfibrozil, HIV protease inhibitors (eg, indinavir, ritonavir), HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), macrolides (eg, clarithromycin, erythromycin), nefazodone, repaglinide, rosiglitazone, sildenafil, or telithromycin because they may increase the risk of Onxol's side effects
  • Carbamazepine, efavirenz, nevirapine, phenytoin, or rifampin because they may decrease Onxol's effectiveness
  • Anticoagulants (eg, warfarin) or doxorubicin because the risk of their side effects may be increased by Onxol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Onxol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Onxol:

Use Onxol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Onxol. Talk to your pharmacist if you have questions about this information.
  • Onxol is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
  • If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.
  • You should receive certain other medicines, such as corticosteroids (eg, prednisone), diphenhydramine, and H2 blocker (eg, famotidine), before each treatment with Onxol to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
  • Wear gloves while handling Onxol.
  • If you get Onxol on your skin, rinse the area thoroughly with soap and water. If you get Onxol in your eyes, nose, or mouth, flush the area thoroughly with water.
  • If you miss a dose of Onxol, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Onxol.

Important safety information:

  • Serious allergic reactions, some fatal, have occurred with the use of Onxol. You will need to take certain other medicines before using Onxol in order to lessen the risk of having an allergic reaction. Stop using Onxol and notify your doctor immediately if you develop signs of an allergic reaction, such as rash; itching; severe dizziness or light-headedness; swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
  • Some patients develop redness or sores in the mouth or on the lips. These symptoms may occur a few days after treatment with Onxol and usually decrease or disappear in 1 week. Talk with your doctor about proper mouth care and other ways to prevent or reduce this side effect.
  • Onxol may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Onxol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Onxol has alcohol in it and may interact with other medicines. Alcohol in drinks or other medicines may increase the effects of Onxol. Before you start any new medicine, check the label to see if it has alcohol in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Onxol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Onxol may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
  • Do not receive a live vaccine (eg, measles, mumps) while you are using Onxol.
  • Talk with your doctor before you receive any vaccine.
  • Tell your doctor or dentist that you take Onxol before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts, vital signs (such as pulse and blood pressure), and liver function, may be performed while you use Onxol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Onxol with caution in the ELDERLY; they may be more sensitive to its effects, especially effects on the bone marrow (myelosuppression), nerve problems, or heart problems.
  • Onxol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Women who may become pregnant should use effective birth control (eg, condoms) while using Onxol. Talk with your doctor if you have questions about effective birth control.
  • Men who use Onxol should talk with their doctor about the use of effective birth control when having sex with a woman who may become pregnant.
  • PREGNANCY AND BREAST-FEEDING: Onxol has been shown to cause harm to the fetus. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Onxol while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using Onxol.

Possible side effects of Onxol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; general feeling of discomfort; hair loss; mild joint or muscle pain; nausea; numbness, tingling, or burning of the arms, hands, legs, or feet; redness and/or sores on the mouth or lips; weakness or tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; flushing; swelling of the mouth, face, lips, tongue, or throat; hoarseness); calf or leg redness, swelling, pain, or tenderness; change in the amount of urine produced; chest pain; discomfort, pain, redness, or swelling at the injection site; fainting; fast, slow, or irregular heartbeat; open sores on the skin; pale appearance; red, swollen, blistered, or peeling skin; severe or persistent joint or muscle pain; severe or persistent nausea, vomiting, or diarrhea; severe or persistent numbness, tingling, or burning in the arms, hands, legs, or feet; severe or persistent stomach pain; sudden or severe dizziness, light-headedness, or headache; sudden, unexplained weight gain; swelling of the arms, hands, legs, or feet; symptoms of dehydration (eg, dry mouth or eyes, increased thirst, sluggishness); symptoms of infection (eg, fever, chills, sore throat); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include burning, numbness, or tingling; redness and/or sores on the mouth or lips; symptoms of infection (eg, fever, chills, persistent sore throat); unusual bruising or bleeding; unusual tiredness or weakness.

Proper storage of Onxol:

Onxol is usually handled and stored by a health care provider. Keep Onxol out of the reach of children and away from pets.

General information:

  • If you have any questions about Onxol, please talk with your doctor, pharmacist, or other health care provider.
  • Onxol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Onxol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Onxol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Onxol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Onxol.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.