Cabazitaxel, Injection

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KEY POINTS

• This medicine is given by IV infusion to treat advanced or spreading prostate cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for blood tests or exams.
• This medicine may cause allergic reactions, severe vomiting or diarrhea, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: cabazitaxel, injection; Jevtana

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat advanced or spreading prostate cancer. It is used along with prednisone.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to polysorbate 80
• Kidney or liver disease
• Low levels of white blood cells
• Lung or breathing problems such as asthma, COPD, or sleep apnea

This medicine may make men sterile (unable to have children). If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

This medicine is given by IV infusion, usually over a 1-hour period every 3 weeks. These infusions are given by a healthcare provider at a clinic or hospital. Before receiving the infusion you may be given other medicines to help prevent side effects.

While receiving this medicine, you will take prednisone daily. Take the prednisone exactly as your healthcare provider prescribes.

Ask your healthcare provider if you have questions about the medicines you are receiving.

What should I watch out for?

This is a very strong medicine. It should only be given where you can be monitored closely. You will need blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause serious allergic reactions. Tell your healthcare provider right away if you experience cough, breathing problems, rash, itching, skin redness, severe dizziness, fainting, chest or throat tightness, or swelling of your face while you are receiving this medicine.

This medicine may lower the number of certain types of blood cells in your body and cause you to get infections more easily. Contact your healthcare provider right away if you have any symptoms of infection such as cough, fever, chills, or burning on urination. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you have vomiting or diarrhea while you are receiving this medicine, contact your healthcare provider right away. Death has happened from losing too much body fluid from severe vomiting or diarrhea.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, or throat; trouble breathing).

Serious (Report these to your healthcare provider right away.): Chest pain; fever; cough; shortness of breath; swelling in your arms or legs, or any unexplained swelling; muscle aches; burning when urinating or blood in your urine; decreased urination; numbness or burning in your hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; severe diarrhea or vomiting; severe stomach pain or constipation; bloody bowel movements; yellowing of skin or eyes; confusion; problems with vision, speech, or balance.

Other: Nausea; vomiting; diarrhea; constipation; tiredness; loss of appetite; weakness; back or joint pain; change in sense of taste; hair loss; headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), isoniazid, metronidazole, nafcillin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin) and nefazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as clozapine (Clozaril, FazaClo), haloperidol (Haldol), and iloperidone (Fanapt)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and simeprevir (Olysio)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), crizotinib (Xalkori), enzalutamide (Xtandi), imatinib (Gleevec), and mitotane (Lysodren)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Live vaccines
• Lomitapide (Juxtapid)
• Mifepristone (Korlym, Mifeprex)
• St. John's wort

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.