What is Jevtana?

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• Blackbox Warning
• Overview
• Proper Use
• Before Using
• Allergies
• Pediatric
• Geriatric
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Cabazitaxel injection is given together with a steroid medicine (eg, prednisone) to treat men with metastatic (cancer that has already spread) castration-resistant prostate cancer (prostate cancer that cannot be treated by surgery or medicines that lower testosterone). It is used in patients who have already been treated with other medicines (eg, docetaxel) that did not work well.

Cabazitaxel belongs to the group of medicines called antineoplastics (cancer medicines). It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be given only by or under the direct supervision of your doctor.

Proper UseTOP

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is usually given together with oral prednisone. Your doctor will tell you how much prednisone to take and how often.

You may also receive other medicines (eg, allergy medicine, steroids, or H2 blocker) to help prevent allergic reactions, nausea, and vomiting from the injection.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

AllergiesTOP

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

PediatricTOP

Appropriate studies have not been performed on the relationship of age to the effects of cabazitaxel injection in the pediatric population. Safety and efficacy have not been established.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabazitaxel injection in the elderly. However, elderly patients are more likely to have unwanted side effects (including febrile neutropenia), which may require caution in patients receiving cabazitaxel.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Ceritinib
• Cholera Vaccine, Live
• Clarithromycin
• Cobicistat
• Conivaptan
• Delavirdine
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Poliovirus Vaccine, Live
• Posaconazole
• Ritonavir
• Saquinavir
• Smallpox Vaccine
• Telaprevir
• Telithromycin
• Tipranavir
• Typhoid Vaccine
• Voriconazole
• Yellow Fever Vaccine

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to polysorbate 80 (preservative in the product) or
• Liver disease, severe or
• Neutropenia (low white blood cells)—Should not be used in patients with these conditions.

• Anemia or
• Diarrhea or
• Dehydration or
• Kidney disease, severe or
• Lung disease (eg, acute respiratory distress syndrome, interstitial lung disease, interstitial pneumonia) or
• Stomach ulcer or bleeding, history of or
• Thrombocytopenia (low platelets in the blood) or
• Weak immune system—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight an infection.

• Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

PrecautionsTOP

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while your partner is pregnant can harm your unborn baby. Use an effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think your partner has become pregnant while you are receiving this medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before receiving this medicine. Some men receiving this medicine have become infertile (unable to have children).

Cabazitaxel can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause serious allergic reactions. Tell your doctor right away if you have a cough, dizziness, trouble breathing, chest or throat tightness, swelling in your face or hands, fever, chills, rash, itching or hives, skin redness, or lightheadedness or faintness while you are receiving this medicine.

Cabazitaxel may cause serious stomach or bowel problems. This is more likely in patients who have had radiation treatment in the pelvis. Call your doctor right away if you have fever, constipation, diarrhea, or stomach pain or tenderness.

Kidney failure may occur with this medicine. Check with your doctor right away if you have confusion, decreased urine output, dizziness, irritability, lethargy, muscle twitching, nausea, rapid weight gain, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

This medicine may cause problems in passing urine, including cystitis (inflammation of the bladder). Check with your doctor right away if you have bloody or cloudy urine, difficult, burning, or painful urination, or a frequent urge to urinate.

Lung or breathing problems may occur while you are receiving this medicine, Tell your doctor right away if you have a chest pain, cough, fever, or trouble with breathing after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.