Important Safety Information
What is the most important information I should know about JEVTANA (cabazitaxel)?
JEVTANA may cause serious side effects, including:

• Low white blood cell counts are common during treatment with JEVTANA, and can cause serious infections that may lead to death. Men who are 65 years or older may be more likely to have these problems. Your healthcare provider (HCP):
  • will do blood tests regularly to check your white blood cell counts during your treatment with JEVTANA.
  • may lower your dose of JEVTANA, change how often you receive it, or stop JEVTANA until your HCP decides that you have enough white blood cells.
  • may prescribe a medicine for you called G-CSF, to help prevent complications if your white blood cell count is too low.

Tell your HCP right away if you have any of these symptoms of infection during treatment with JEVTANA: fever (take your temperature often during treatment with JEVTANA), cough, burning on urination, or muscle aches.
Also, tell your HCP if you have any diarrhea during the time that your white blood cell count is low. Your HCP may prescribe treatment for you as needed.

• Severe allergic reactions can happen within a few minutes after your infusion of JEVTANA starts, especially during the first and second infusions. Your HCP should prescribe medicines before each infusion to help prevent severe allergic reactions.

Tell your HCP right away if you have any of these symptoms of a severe allergic reaction during or soon after an infusion of JEVTANA: rash or itching, skin redness, feeling dizzy or faint, breathing problems, chest or throat tightness, or swelling of face.

• Severe stomach and intestine (gastrointestinal) problems.

- JEVTANA can cause severe vomiting and diarrhea, which may lead to death. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration), or too much of your body salts (electrolytes). Death has happened from having severe diarrhea and losing too much body fluid or body salts with JEVTANA. You may need to go to the hospital for treatment. Your HCP will prescribe medicines to prevent or treat vomiting and diarrhea, as needed with JEVTANA.

Tell your HCP if you have vomiting or diarrhea, or if your symptoms get worse or do not get better.

- JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine, which may lead to death.

Tell your HCP if you get any of these symptoms: severe stomach-area (abdomen) pain, constipation, fever, blood in your stool, or changes in the color of your stool.

• Kidney failure may happen with JEVTANA, because of severe infection, loss of too much body fluid (dehydration), and other reasons, which may lead to death. Your HCP will check you for this problem and treat you if needed.
• Tell your HCP if you develop these signs or symptoms: swelling of your face or body, decrease in the amount of urine that your body makes each day or blood in your urine.
• Inflammation of the bladder and blood in the urine. Blood in the urine is common with JEVTANA, but it can also sometimes be severe. Some people who have had pelvic radiation in the past may develop inflammation of the bladder and blood in the urine that is severe enough that they need to be hospitalized for medical treatment or surgery. Your healthcare provider will check you for these problems during treatment with JEVTANA. Your healthcare provider may stop your treatment with JEVTANA for a short time, or permanently, if you develop inflammation of the bladder and bleeding that is severe.
• Lung or breathing problems may happen with JEVTANA and may lead to death. Men who have lung disease before receiving JEVTANA may have a higher risk for developing lung or breathing problems with JEVTANA treatment. Your HCP will check you for this problem and treat you if needed.

Tell your HCP right away if you develop any new or worsening symptoms, including trouble breathing, shortness of breath, chest pain, cough or fever.

Who should not receive JEVTANA?
Do not receive JEVTANA if: your white blood cell (neutrophil count) is too low, you have had a severe allergic reaction to cabazitaxel or other medicines that contain polysorbate 80 (ask your HCP if you are not sure), or you have severe liver problems.

What should I tell my HCP before receiving JEVTANA?
Before receiving JEVTANA, tell your HCP if you:

• are age 65 or older
• had allergic reactions in the past
• have kidney or liver problems
• have lung problems
• are pregnant or plan to become pregnant. JEVTANA can cause harm to your unborn baby and loss of pregnancy (miscarriage).
• are a male with a female partner who is able to become pregnant. Males should use effective birth control (contraception) during treatment with JEVTANA and for 4 months after the last dose of JEVTANA.

JEVTANA may cause fertility problems in males. This may affect your ability to father a child. Talk to your HCP if you have concerns about fertility.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. JEVTANA can interact with many other medicines. Do not take any new medicines without asking your HCP first. Your HCP will tell you if it is safe to take the new medicine with JEVTANA.

What are the most common side effects of JEVTANA?
The most common side effects of JEVTANA include:

• low red blood cell count (anemia), which is common with JEVTANA, but can sometimes also be serious. Your HCP will regularly check your red blood cell count. Symptoms of anemia include shortness of breath and tiredness.
• low blood platelet count, which is common with JEVTANA, but can sometimes also be serious. Tell your HCP if you have any unusual bruising or bleeding.
• diarrhea
• tiredness
• nausea
• vomiting
• constipation
• back pain
• decreased appetite
• stomach (abdominal) pain
• weakness

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of JEVTANA. For more information, ask your HCP or pharmacist.

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

INDICATION
JEVTANA (cabazitaxel) is a prescription medicine used with the steroid medicine prednisone to treat men with castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone) that has spread to other parts of the body, and that has worsened (progressed) after treatment with other medicines that included docetaxel.

It is not known if JEVTANA is safe and effective in females or children.

Please see full Prescribing Information / Patient Information, including Serious Side Effects.

--Brand Name--
US Brand Name: Jevtana

--Description--
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.

This product is available in the following dosage forms: Solution

--Before Using--
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:

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.

Pediatric
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.

Geriatric
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.

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.

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

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine

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 Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Atazanavir
• Boceprevir
• Ceritinib
• Cholera Vaccine
• Clarithromycin
• Cobicistat
• Conivaptan
• Delavirdine
• Ebola Zaire Vaccine, Live
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Posaconazole
• Ritonavir
• Rotavirus Vaccine, Live
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

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

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
• Dehydration or
• Diarrhea 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.

--Proper Use--
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) at least 30 minutes before receiving this medicine to help prevent allergic reactions, nausea, and vomiting from the injection.

Precautions
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.

Receiving 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 4 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 or vitamin supplements.

--Side Effects--
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 or tightness
• 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
• 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

Incidence not known

• Blue lips, fingernails, or skin
• burning feeling in the chest or stomach
• fast breathing
• frequent urination
• general feeling of discomfort or illness
• indigestion
• lower abdominal cramping
• nausea
• severe constipation
• stomach pain or upset
• tenderness in the stomach area
• thickening of bronchial secretions
• vomiting

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

• 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
• stomach discomfort
• thinning of the hair
• weight loss

Less common

• Back pain
• difficulty with moving
• muscle pain, spasm, or stiffness
• 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.