Patient Medication Information: uses, side effects, how to take - Jevtana
What is JEVTANA used for?
JEVTANA is used with prednisone and prednisolone to treat prostate cancer in adults who have been previously treated with docetaxel and who have:
- Prostate cancer that has spread to other parts of the body (metastasized)
- Prostate cancer that no longer responds to hormone treatment
How does JEVTANA work?
Every cell in your body contains a supporting structure. If this structure is damaged, the cell cannot grow or divide.
JEVTANA makes the structure in cells unnaturally stiff, so the cancer cells can no longer grow or divide.
What are the ingredients in JEVTANA?
Medicinal ingredients: Cabazitaxel
Non-medicinal ingredients: ethanol and polysorbate 80 (including citric acid).
JEVTANA comes in the following dosage forms:
Solution for Injection: 60 mg / 1.5mL
Do not use JEVTANA if:
you have a history of severe allergic reactions to:
- cabazitaxel, or
- other medicines containing polysorbate 80, or
Serious Warnings and Precautions
JEVTANA should only be given by a qualified healthcare professional experienced in the use of anticancer treatments.
Possible serious side effects with the use of JEVTANA include:
- Serious allergic reactions
- Low white blood cell count that can lead to life-threatening infection and death
- Gastrointestinal (GI) bleeding and perforation (a hole in the wall of your stomach or bowels) that can lead to death, especially in patients with a higher risk of developing GI complications
- any of the other ingredients in the formulation
- your white blood cell count is too low
- you have a severe liver disease.
- you have recently received or you are about to receive the yellow fever vaccine.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JEVTANA. Talk about any health conditions or problems you may have, including if you:
- you have a decreased ability to produce blood cells
- have anemia (low number of red blood cells)
- have or had gastrointestinal problems
- have stomach pain, fever, persistent constipation which may be a sign of gastrointestinal problems
- have severe or persistent diarrhea, nausea or vomiting which may result in dehydration.
- have a history of diseases of digestive tract
- have a fever. A fever is the earliest sign of infection which may be caused by reduced white blood cell count.
- have any allergies. Antiallergic medicines will be given to you to reduce the risk of an allergic reaction, as JEVTANA may also cause serious allergic reactions (hypersensitivity).
- have previously received pelvic radiotherapy
- have liver or kidney problems.
- have inflammation of the bladder.
- have a heart problem or an irregular heart rate
- new or worsening lung problems
- are over the age of 65
you are pregnant or planning on becoming pregnant
- you are breast-feeding or planning on breast-feeding. JEVTANA should not be used while breast-feeding
- are going to have any vaccines. JEVTANA should not be used if you have recently received or you are about to receive a live vaccine (such as yellow fever vaccine), since concomitant use may result in serious life-threatening infections.
Other warnings you should know about:
Contraception for Men: JEVTANA might be present in your semen. Use a condom every time you have sexual intercourse with a woman who is pregnant or can get pregnant while you are taking JEVTANA and for 6 months after your last dose. You should talk to your doctor about preserving your sperm prior to receiving JEVTANA.
Driving and Using Machinery: JEVTANA may cause fatigue or dizziness. If you experience these symptoms, do not drive or use any tools or machines. Laboratory Test: Your doctor will perform blood tests on a weekly basis and before each treatment cycle.
Problems with your Nervous System: JEVTANA can cause weakness, numbness and pain, usually in the hands and feet.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with JEVTANA:
- medicines used to treat infections, such as: ketoconazole, itraconazole, rifampicin, clarithromycin, indinavir nelfinavir, ritonavir, saquinavir, voriconazole
- medicines used to treat seizures, such as: carbamazepine, phenytoin, phenobarbital.
- live vaccines
How to take JEVTANA:
- JEVTANA will be given to you as an infusion into the vein (intravenous infusion) by a healthcare professional every 3 weeks.
- The infusion will take about 1 hour.
- Your healthcare professional may also give you other medicines by injection, into the vein, to reduce your risk of experiencing an allergic reaction
- During treatment with JEVTANA you will also need to take 10 mg of prednisone or prednisolone orally every day.
Usual dose:
Your healthcare professional will decide the dose of JEVTANA you should receive based on your height and weight.
Overdose:
| If you think you, or a person you are caring for, have been given too much JEVTANA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
|---|
Missed Dose:
This medicine needs to be given on a fixed schedule. If you miss an appointment, call your doctor or nurse for instructions.
What are possible side effects from using JEVTANA?
These are not all the possible side effects you may have when taking JEVTANA. If you experience any side effects not listed here, tell your healthcare professional.
- diarrhea, nausea, vomiting, constipation, abdominal pain
- decreased appetite
- change in the sense of taste
- blood in the urine (hematuria)
- hair loss
- tiredness
- muscle pain, muscle spasms, or joint pain or joint stiffness
- back pain
- weakness
- cough
- shortness of breath
- acid reflux (Gastroesophageal Reflux Disease)
- low blood pressure
- headache
- dizziness
- dehydration
- urinary tract infection
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Fever, chills or signs of infection, like redness or swelling at the injection site, a cough that brings up mucus, or a sore throat | √ | ||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||
| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms | √ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness | √ | ||
| Persistent vomiting or diarrhea; abdominal pain, abdominal tenderness, persistent constipation, dark stool or blood in stool. | √ | ||
| Gastrointestinal (GI) bleeding (bleeding anywhere along the GI tract between mouth and anus): blood in vomit, black tarry stool, bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness; | √ | ||
| Gastrointestinal perforation (a hole in the wall of your stomach or bowels): severe abdominal pain | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| and tenderness, nausea, vomiting, chills or fever | |||
| Kidney symptoms such as blood in the urine, urinary incontinence, decreased amount of urine, pain while urinating, swelling, especially in legs and feet, feeling confused, anxious, restless or sleepy, pain in the back just below the rib cage. | √ | ||
| Acute Kidney failure (severe kidney problems): confusion; itchiness or rashes; puffiness in your face and hands; swelling in your feet or ankles; urinating less or not at all; weight gain. | √ | ||
| Extreme weakness or fatigue | √ | ||
Peripheral neuropathy (damage to nerves outside the brain and spinal cord) with symptoms such as: numbness, tingling, burning or decreased sensation in the hands and feet | √ | ||
| Radiation cystitis (inflammation of the bladder in patients that have received radiotherapy) with symptoms such as: persistent urge to urinate; a burning sensation or pain when urinating; passing frequent, small amounts of urine; blood in the urine (hematuria). | √ | ||
| UNCOMMON | |||
| Allergic reactions such as trouble breathing, tightness in the throat, rash, hives, swelling of the lips or tongue or low blood pressure | √ | ||
| UNKNOWN FREQUENCY | |||
| Respiratory problems with symptoms such as: difficulty breathing, shortness of breath, cough, fatigue. | √ | ||
| Vein thrombosis: blood clot formed in one or more of the veins in your body (usually in the legs or lungs), with symptoms such as: leg pain or swelling; shortness of breath, chest | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| pain, cough; sweating, rapid or irregular heartbeat, dizziness. | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
The unopened vials should be stored at room temperature between 15°C to 30°C. JEVTANA is stored with your healthcare professional.
If you want more information about JEVTANA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.sanofi.ca, or by calling 1-800-265-7927.