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Jevtana intravenous

GENERIC NAME(S): CABAZITAXEL

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.

Who should not take Jevtana intravenous?
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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 intravenous

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.

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 right away if you have any serious side effects, including: 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, persistent constipation, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

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.

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), stomach/abdominal problems (such as ulcers, bleeding, blockage), 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.

Interactions

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 directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. 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), 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.

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 April 2014. Copyright(c) 2014 First Databank, Inc.

Images

JEVTANA 60 MG/1.5 ML KIT
JEVTANA 60 MG/1.5 ML KIT
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JEVTANA 60 MG/1.5 ML KIT
JEVTANA 60 MG/1.5 ML KIT

Identification

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This medicine is a yellow vial.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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