Jevtana

Jevtana is given together with a steroid medicine (e.g. prednisone) to treat men with metastatic (cancer that has already spread) prostate cancer. It is used in patients who have already been treated with other medicines 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 immediate supervision of your doctor.

This product is available in the following dosage forms: Solution.

Before using Jevtana, you must know all about the risks and complications associated with it.

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:

1. Allergies

   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.

2. Pediatric Population

   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.

3. Geriatric Population

   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, which may require caution in patients receiving cabazitaxel.

4. Pregnancy

   Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

5. Breastfeeding

   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.

6. Drug Interactions

   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 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.

   Aprepitant, Atazanavir, Boceprevir, Ceritinib, Clarithromycin, Cobicistat,Conivaptan, Crizotinib, Dabrafenib, Dasabuvir, Delavirdine,
   Fosaprepitant, Idelalisib, Imatinib, Indinavir Itraconazole Ketoconazole Lopinavir Nefazodone Nelfinavir Nilotinib Piperaquine Posaconazole Ritonavir Saquinavir Telaprevir Telithromycin Tipranavir Topotecan Voriconazole

7. Other Interactions

   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

8. Other Medical Problems

   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
• 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.

To use Jevtana properly, you must follow all instructions given by your doctor.

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.

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

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 to help prevent allergic reactions and nausea from the injection.

Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Before using Jevtana, there are some precautions you must take.

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

• Risk of Infections:

  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.

• Allergic Reactions:

  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 light-headedness or faintness while you are receiving this medicine.

  Cabazitaxel may cause serious stomach or bowel problems. 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.

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 (e.g. St. John's wort) or vitamin supplements.

As with many medications, there are several potential side effects associated with Jevtana.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools
• Bleeding gums
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Blood in the urine or stools
• Burning, numbness, tingling, or painful sensations
• Chest pain
• Chills
• Cough
• Difficult or labored breathing
• Difficult or painful urination
• Fever
• Lower back or side pain
• Pale skin
• Pinpoint red spots on the skin
• Rapid weight gain
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Tightness in the chest
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Weakness in the arms, hands, legs, or feet

Less common

• Blurred vision
• Confusion
• Decreased urination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Fainting
• Fast, slow, or irregular heartbeat
• Lightheadedness
• Rapid breathing
• Sunken eyes
• Sweating
• Thirst
• Wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain
• Acid or sour stomach
• Belching
• Change in taste
• Constipation
• Cracked lips
• Decreased weight
• Diarrhea
• Difficulty with swallowing
• Hair loss
• Headache
• Heartburn
• Indigestion
• Lack or loss of strength
• Loss of appetite
• Nausea
• Stomach discomfort, upset, or pain
• Thinning of the hair
• Vomiting
• Weight loss

Less common

• Back pain
• Difficulty with moving
• Muscle pain or stiffness
• Muscle spasms
• Pain in the joints
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.