Jevtana

Jevtana (cabazitaxel) is a prescription chemotherapy medicine used to treat advanced metastatic castration-resistant prostate cancer (mCRPC) that has spread or progressed after being treated with docetaxel regimen. Jevtana helps stop cancer cells from growing and dividing to help increase overall survival.

Jevtana is administered as an intravenous infusion every three weeks. Infusions take approximately 1 hour.

Jevtana is used in combination with prednisone.

Jevtana is a microtubule inhibitor from the group of cancer medicines known as ‘taxanes’. Jevtana works by interfering with microtubules, structures in cancer cells that are needed to divide. By blocking microtubules, Jevtana prevents cancer cells from multiplying, leading to cell death.

In the TROPIC Trial (NCT00417079), Jevtana significantly improved overall survival compared with mitoxantrone. In the trial, 755 men with metastatic castration-resistant prostate cancer previously treated with docetaxel were treated with Jevtana or with mitoxantrone, both were given with prednisone or prednisolone.

Patients treated with Jevtana average overall survival of 15.1 months, versus 12.7 months for those receiving mitoxantrone, demonstrating that Jevtana prolonged the average length of time the patients lived.

Jevtana is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take about 1 hour to complete.

Jevtana is usually given once every 3 weeks. You will be given other medications to prevent certain side effects.

You will most likely take prednisone (a steroid medicine) by mouth every day throughout your Jevtana treatment. Do not stop taking prednisone without your doctor's advice, or you could have unpleasant side effects caused by Jevtana. Tell your doctor if you miss any doses or you stop taking prednisone for any reason.

Jevtana affects your immune system. You may get infections more easily, even serious or fatal infections, especially if you are 65 or older. Your doctor will need to examine you on a regular basis.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while receiving Jevtana, which can lead to a serious electrolyte imbalance.

Your doctor may tell you to check your temperature at home throughout your treatment with Jevtana.

Jevtana has a boxed warning for neutropenia and hypersensitivity. A boxed warning is the strongest safety-related warning issued by the FDA.

Neutropenia: Jevtana can cause neutropenia (low number of neutrophils), which are an important type of white blood cell that fights bacterial and fungal infections. This can lead to febrile neutropenia, neutropenic infections, and death. There is a higher risk if you are 65 or older. Blood counts should be monitored frequently to determine if dosage modification or initiation of G-CSF is needed. Call your doctor if you have a fever, muscle pain, cough, diarrhea, or pain or burning when you urinate.

Hypersensitivity: Severe hypersensitivity reactions can occur with this medicine. Premedicate with corticosteroids and H2 antagonists. Discontinue infusion immediately if hypersensitivity is observed and treat as indicated.

Other warnings:

You should not use Jevtana if you have severe liver disease, low white blood cell counts, or an allergy to any medicine that contains polysorbate 80.

Call your doctor right away if you have symptoms such as: fever, cough, body aches, easy bruising or bleeding, burning when you urinate, decreased urination, swelling in your hands or feet, severe stomach pain, constipation, blood in your urine or stools, or sudden chest pain and shortness of breath.

You should not use Jevtana if you are allergic to cabazitaxel, or if you have:

• severe liver disease;
• low white blood cell counts; or
• an allergy to any medicine that contains polysorbate 80.

To make sure Jevtana is safe for you, tell your doctor if you have ever had:

• radiation treatment;
• liver or kidney disease;
• breathing problems; or
• a severe allergic reaction to any medication.

Although not for use by women, cabazitaxel can cause birth defects in a baby if the father is using this medicine.

Pregnancy and fertility

Use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose. Tell your doctor at once if a pregnancy occurs during this time.

This medicine may affect fertility (your ability to have children). However, it is important to use birth control to prevent pregnancy because cabazitaxel can harm an unborn baby.

Common side effects

Common Jevtana side effects may include:

• fever, low blood cell counts;
• numbness or tingling;
• nausea, vomiting, stomach pain, loss of appetite;
• constipation, diarrhea;
• weakness, tired feeling;
• blood in your urine;
• back pain, joint pain;
• cough, shortness of breath;
• altered sense of taste; or
• hair loss.

Serious side effects

Jevtana can cause a serious allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Jevtana: hives, rash or skin redness; chest tightness or trouble breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Jevtana can cause serious or fatal side effects. Call your doctor at once if you have:

• numbness, burning pain, or tingly feeling in your hands or feet;
• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
• stomach pain or tenderness, severe vomiting or diarrhea, ongoing constipation;
• blood in your urine, urinating more often, pain or burning when you urinate;
• low blood cell counts - fever, chills, muscle pain, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your hands or feet; feeling tired or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Some side effects may be more likely in older adults.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Prostate Cancer:

25 mg/m2 IV over 1 hour every three weeksComments:-Use in combination with prednisone or prednisolone.-Give premedication regimen at least 30 minutes prior to each administration.-Give antiemetics prophylactically or as needed.-Ensure adequate hydration throughout treatment.Use: Use in combination with prednisone or prednisolone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Call your doctor for instructions if you miss an appointment for your Jevtana injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe vomiting or diarrhea, fever, or worsening flu-like symptoms.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with cabazitaxel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Active ingredient: cabazitaxel

Inactive ingredients: polysorbate 80, citric acid monohydrate