Cabazitaxel is used to treat prostate cancer. It works by slowing or stopping the growth of cancer cells.

Read the Patient Information Leaflet if available from your pharmacist before you start using cabazitaxel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually every 3 weeks. A health care professional will give you the injection slowly over 1 hour.

Your doctor may prescribe other medications (such as antihistamines, H2 blockers, corticosteroids) before each injection of cabazitaxel to lessen the risk of allergic reactions and prevent side effects such as nausea/vomiting.

The dosage is based on your medical condition, body size, lab tests, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

See also Warning section.

Loss of appetite, stomach/abdominal pain, or change in sense of taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, or diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Many people using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• constipation that doesn't go away
• signs of kidney problems (such as change in the amount of urine, pink/bloody urine)
• signs of a bladder infection (such as burning/pain when you urinate, urgent or frequent urination, fever)
• muscle cramps
• weakness
• dizziness
• extreme thirst
• unusual tiredness
• fast/irregular heartbeat
• easy bruising/bleeding
• numbness/tingling of arms/legs
• severe stomach/abdominal pain
• black/tarry stools
• vomit that looks like coffee grounds

Get medical help right away if you have any very serious side effects, including:

• chest pain

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving cabazitaxel, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (taxane-type drugs such as paclitaxel, docetaxel); or to polysorbate 80; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• lung disease
• blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia)
• stomach/abdominal problems (such as ulcers, bleeding, blockage)
• recent/current infections
• radiation treatment

Cabazitaxel can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using cabazitaxel before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for side effects (such as low number of white blood cells, fever, dizziness, bladder infections, dehydration) while using this drug.

This medication should not be used in women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Men using this medication should ask about reliable forms of birth control while using this medication and for some time after the last dose. Consult your doctor for more details.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of cabazitaxel from your body, which may affect how cabazitaxel works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin), nefazodone, HIV protease inhibitors (such as nelfinavir), ritonavir, telithromycin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, kidney function) must be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).