Generic Name: cabazitaxel (Ka-BAZ-i-TAX-el)
Brand Name: Jevtana
Low white blood cell levels have been reported in patients using Jevtana. This has resulted in severe and sometimes fatal side effects (eg, infection). Lab tests, including complete blood cell counts, will be monitored while you use Jevtana. Patients with low levels of a certain type of white blood cell (neutrophils) should not use Jevtana. Contact your doctor right away if you experience symptoms of infection (eg, fever, chills, sore throat, cough, frequent or painful urination, muscle aches).
Severe and sometimes fatal allergic reactions have occurred with the use of Jevtana. Seek medical care at once if you experience fainting; a rash; reddening of the skin; tightness in the chest or throat; swelling of the mouth, face, or tongue; severe dizziness; wheezing; or trouble breathing. You will receive other medicines before your dose of Jevtana to help decrease the chance of an allergic reaction. Do not use Jevtana if you have had an allergic reaction to Jevtana or to other medicines that contain polysorbate 80.
Jevtana is used for:
Treating prostate cancer in certain patients. It is used along with prednisone. It may also be used for other conditions as determined by your doctor.
Jevtana is an antineoplastic agent. It works by stopping the growth and reproduction of cancer cells in the body.
Do NOT use Jevtana if:
- you are allergic to any ingredient in Jevtana
- you are allergic to other medicines that contain polysorbate 80
- you have liver problems
- you have low levels of a certain type of white blood cell (neutrophils)
- you are taking certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, clarithromycin, cobicistat, dexamethasone, efavirenz, enzalutamide, felbamate, griseofulvin, hydantoins (eg, phenytoin), mifepristone, modafinil, nefazodone, nevirapine, oxcarbazepine, primidone, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifabutin, rifampin, rifapentine), St. John's wort, telithromycin, or topiramate
- you have taken or will be taking palifermin within 24 hours before or after using Jevtana
Contact your doctor or health care provider right away if any of these apply to you.
Before using Jevtana:
Some medical conditions may interact with Jevtana. 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
- you are able to become pregnant
- 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 history of liver problems, kidney problems, stomach or bowel problems, long-term infection, or infection that keeps coming back
- if you have an infection, bone marrow problems, a weakened immune system, low white blood cell count, or poor nutrition, or you are dehydrated
Some MEDICINES MAY INTERACT with Jevtana. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), cobicistat, macrolide antibiotics (eg, erythromycin, clarithromycin), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Jevtana's side effects
- Barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, efavirenz, enzalutamide, felbamate, griseofulvin, hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, primidone, rifamycins (eg, rifabutin, rifampin, rifapentine), St. John's wort, or topiramate because they may decrease Jevtana's effectiveness
- Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
This may not be a complete list of all interactions that may occur. Ask your health care provider if Jevtana 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 Jevtana:
Use Jevtana as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Jevtana. Talk to your pharmacist if you have questions about this information.
- Jevtana is given as an injection at your doctor's office, hospital, or clinic.
- You will receive certain other medicines at least 30 minutes before each treatment with Jevtana. This will help decrease the chance of having an allergic reaction to Jevtana. Discuss any questions with your doctor.
- Jevtana is used along with another medicine (prednisone). It is important to take the prednisone as recommended by your doctor. Tell your doctor if you have missed a dose of prednisone or if you have not taken it as prescribed.
- If Jevtana comes into contact with your skin, wash it off right away with soap and water.
- If Jevtana comes into contact with your eyes, nose, or mouth, wash right away with cool water.
- If you miss a dose of Jevtana, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Jevtana.
Important safety information:
- Jevtana may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Jevtana with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Jevtana may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Take your temperature on a regular basis. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Jevtana 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.
- Tell your doctor or nurse if you develop joint pain. They may be able to suggest ways to make you more comfortable.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Severe diarrhea and vomiting may occur with Jevtana. If not treated, this may cause severe and sometimes fatal fluid and electrolyte (eg, potassium, sodium) problems. Contact your doctor if you have severe diarrhea or vomiting. You may need to take an anti-diarrhea medicine, an anti-nausea medicine, fluids, or electrolyte replacements.
- Jevtana may cause severe and sometimes fatal kidney problems. Tell your doctor right away if you experience symptoms of kidney problems (eg, decreased amount of urine produced, swelling of the face or body).
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Jevtana. Talk with your doctor before you receive any vaccine.
- Women who are able to become pregnant should use an effective form of birth control while using Jevtana. Discuss with your doctor any questions you may have about effective birth control.
- Lab tests, including complete blood cell counts, may be performed while you use Jevtana. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Jevtana with caution in the ELDERLY; they may be more sensitive to its effects, especially low white blood cell levels, dehydration, dizziness, tiredness, fever, increased or painful urination, or weakness.
- Jevtana should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Jevtana may cause harm to the fetus. Do not become 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 Jevtana while you are pregnant. It is not known if Jevtana is found in breast milk. Do not breast-feed while taking Jevtana.
Possible side effects of Jevtana:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; constipation; diarrhea; dizziness; hair loss; indigestion; joint pain; loss of appetite; mild pain, swelling, or redness at the injection site; mild weight loss; muscle spasms; nausea; numbness, tingling, burning, or decreased sensation in the hands or feet; taste changes; stomach pain; vomiting; weakness or tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); blood in the urine; confusion; fainting; fast, slow, or irregular heartbeat; mouth sores or inflammation; one-sided weakness; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent weakness or tiredness; severe or persistent weight loss; shortness of breath; slurred speech; symptoms of bleeding in the brain (eg, confusion, one-sided weakness, vision problems, slurred speech); symptoms of dehydration (eg, very dry skin, mouth, or eyes; weakness; increased thirst; fast or irregular heartbeat); symptoms of infection (eg, fever, chills, sore throat, cough, increased or painful urination, muscle aches, swollen lymph glands); symptoms of kidney problems (eg, decreased amount of urine produced, swelling of the face or body); unusual bruising or bleeding; vision problems; wheezing.
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 fever, chills, sore throat, or cough; severe or persistent nausea, vomiting, or diarrhea; severe or persistent weakness or tiredness; unusual bruising or bleeding.Proper storage of Jevtana:
Jevtana is usually handled and stored by a health care provider. Keep Jevtana out of the reach of children and away from pets.
- If you have any questions about Jevtana, please talk with your doctor, pharmacist, or other health care provider.
- Jevtana 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 Jevtana 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 Jevtana. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Jevtana. 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 Jevtana.
Disclaimer: This information should not be used to decide whether or not to take this medicine 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 this medicine.