Pronunciation:

ka-baz-i-TAX-el

Brand Names:

• Jevtana

Dosage Forms:

• Solution

Warnings:

NeutropeniaNeutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts. Cabazitaxel is contraindicated in patients with neutrophil counts of less than or equal to 1500 cells/mm(3). Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features. Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m(2).Severe HypersensitivitySevere hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the cabazitaxel infusion and administration of appropriate therapy. Patients should receive premedication. Cabazitaxel is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to drugs formulated with polysorbate 80 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Mitotic Inhibitor

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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-feeding—

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.

Other medicines—

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
• Dengue Tetravalent Vaccine, Live
• Idelalisib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lopinavir
• Nefazodone
• Nelfinavir
• Poliovirus Vaccine, Live
• Posaconazole
• Ritonavir
• Saquinavir
• Smallpox Vaccine
• Telaprevir
• Telithromycin
• Tipranavir
• Typhoid Vaccine, Live
• Voriconazole
• Yellow Fever Vaccine

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.