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Jevtana IV

Important Note

Warnings
Uses
Side Effects
Precautions
Interactions
Overdose
Jevtana IV Warnings

Cabazitaxel may cause a serious blood disorder (a low number of white blood cells). This effect can lower your body's ability to fight an infection and thus lead to serious (rarely fatal) infections. Your doctor will monitor you closely and check your blood often during treatment. You may also receive another medication to reduce the risk of this side effect. If your white blood cell count is too low, you should not receive cabazitaxel. Tell your doctor immediately if you develop any signs of infection such as fever, chills, cough, persistent sore throat, painful/difficult urination.

Cabazitaxel may infrequently cause serious allergic reactions. This drug must not be used in patients who have previously had an allergic reaction to it or to other medications containing polysorbate 80. Your doctor should prescribe other medications (such as antihistamines, H2 blockers, corticosteroids) to help prevent an allergic reaction. Get medical help right away if you develop any signs of an allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Jevtana IV Uses

Cabazitaxel is used with another medication (prednisone) to treat prostate cancer. It works by slowing or stopping the growth of cancer cells.

How to use Jevtana IV

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 over 1 hour by a health care professional. It is usually given every 3 weeks. While you receive treatment with cabazitaxel, take the prednisone medication as directed by your doctor, usually once daily.

Your doctor may prescribe premedications (such as antihistamines, H2 blockers, corticosteroids) to reduce the risk of allergic reactions or prevent side effects such as nausea/vomiting. These medications are usually given at least 30 minutes before your dose of cabazitaxel.

The dosage is based on your size, medical condition, laboratory test results, and response to treatment.

Jevtana IV Side Effects

See also Warning section.

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

Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor immediately 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 develop serious side effects. However, your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: change in the amount of urine, bloody urine, muscle cramps, weakness, dizziness, extreme thirst, unusual tiredness, fast/irregular heartbeat, easy bruising/bleeding, numbness/tingling of arms/legs.

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.

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

Jevtana IV Precautions

Before receiving cabazitaxel, tell your doctor or pharmacist if you are allergic to it; 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, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), recent/current infections.

Cabazitaxel can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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/loss of too much body water) while using this drug.

Cabazitaxel is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Jevtana IV Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Other medications can affect the removal of cabazitaxel from your body, which may affect how cabazitaxel works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir), nefazodone, rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Jevtana IV Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:

Laboratory and/or medical tests (such as complete blood count, kidney function) must be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

STORAGE:

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

MEDICAL ALERT: 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).

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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