60 mg concentrate and diluent for infusion solution
cabazitaxel
What JEVTANA is and what it is used for
Your medicine is called J EVTANA. The active substance is cabazitaxel. It belongs to a group of drugs called “taxanes” that are used in cancer treatment.
J EVTANA is used to treat prostate cancer that has progressed after receiving other chemotherapy. It works by inhibiting cell growth and cell division.
As part of your treatment, you will also take corticosteroids (prednisone or prednisolone ) by mouth every day. Ask your doctor to inform you about this medicine as well.
What you need to know before you get JEVTANA
Do not use JEVTANA
- if you are allergic (hypersensitive) to cabazitaxel, other taxanes, polysorbate 80 or any of the other ingredients of this medicine (listed in section 6).
- if the white blood cell count is too low ( neutrophils are less than or equal to 1500 / mm 3 ),
- if you have severe hepatic impairment,
- if you have recently been or will be getting the yellow fever vaccine.
You should not use J EVTANA if any of these apply to you. If you are not sure, talk to your doctor before taking J EVTANA.
Warnings and cautions
Before each treatment with J EVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney function to get J EVTANA.
Immediately inform your doctor about:
- you have a fever. During treatment with J EVTANA , your white blood cells are likely to be reduced. Your doctor will monitor your blood count and general condition for signs of infection . Your doctor may give you other medicines to maintain your blood levels. People with low blood counts can develop life-threatening infections . The earliest sign of infection may be a fever, so contact your doctor immediately if you develop a fever.
- you have or have had any allergies . Severe allergic reactions may occur during treatment with J EVTANA .
- you have severe or prolonged diarrhea, feeling unwell or vomiting. Each of these conditions can cause severe dehydration. Your doctor may need to give you care.
- you have a feeling of numbness, tingling, burning or decreased sensation in your hands and feet.
- you have problems with bleeding from the intestines or a change in the color of your stools or stomach pain. If the bleeding or pain is severe, your doctor will stop your treatment with J EVTANA . This is because J EVTANA may increase the risk of bleeding or developing holes in the intestinal wall.
- you have kidney problems.
- you have yellowing of the skin and eyes, dark urine, severe nausea or vomiting, as these may be signs or symptoms of liver problems
- you experience a significant increase or decrease in the volume of daily urine.
- you have blood in your urine
If any of these occur to you, tell your doctor immediately. Your doctor may reduce the dose of J EVTANA or stop the treatment.
Use of other medicines and JEVTANA
Tell your doctor, nurse, or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because certain medicines may affect the effect of J EVTANA or J EVTANA may affect the way these medicines work. These medications are:
- ketoconazole , rifampicin (for infections );
- carbamazepine, phenobarbital or phenytoin (for seizures);
- St. John’s wort (Hypericum perforatum) (herbal medicine for depression and other conditions);
- statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin or pravastatin) (lowers blood cholesterol );
- valsartan (for high blood pressure );
- repaglinide (in diabetes ).
Talk to your doctor before taking any vaccination when you are being treated with J ETANA.
Pregnancy, breastfeeding and fertility
J EVTANA should not be used by pregnant women or women of childbearing potential without the use of contraceptives.
J EVTANA should not be used during breastfeeding.
Use a condom during intercourse if your partner is or may become pregnant. J EVTANA may be present in semen and may affect the fetus. You will be advised not to get pregnant during and up to 6 months after treatment and to seek advice on sperm preservation before treatment as J EVTANA may affect male fertility.
Driving and using machines
You may feel tired or dizzy while taking this medicine. If this happens, do not drive or use any tools or machines until you feel better.
JEVTANA contains ethanol (alcohol)
This medicine contains 573 mg of alcohol ( ethanol ) in each bottle of diluent equivalent to less than 11 ml of beer or 5 ml of wine. The small amount of alcohol that this medicine contains will not have any noticeable effect. If you are addicted to alcohol, have liver disease or epilepsy, talk to your doctor or pharmacist before taking this medicine.
How to use JEVTANA
User instructions
Allergy medicines will be given to you by a doctor or nurse before you receive J EVTANA to reduce the risk of allergic reactions.
- J EVTANA will be given to you by a doctor or nurse.
- J EVTANA must be prepared (diluted) before administration. Practical information regarding the administration and administration of J EVTANA for physicians, nurses and pharmacists is included with this leaflet.
- J EVTANA is given by drip ( infusion ) into one of your veins ( intravenously ) for about one hour in the hospital.
- As part of your treatment, you will also take cortisone medicines (prednisone or prednisolone ) by mouth every day.
How much and how often
- Dose one is determined by your body surface area. Your doctor will calculate your body area in square meters (m 2 ) and will then decide what dose you should have.
- You will usually receive an infusion every three weeks.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the possible risks and benefits of your treatment.
Contact a doctor immediately if you notice any of the following side effects:
- fever (high temperature). This is common (may affect up to 1 in 10 people).
- severe loss of body fluids (dehydration). This is common (may affect up to 1 in 10 people). This can occur if you have severe or prolonged diarrhea or fever or if you have been nauseous (have had vomiting).
- severe abdominal pain or persistent abdominal pain that does not go away. This can occur if you have a hole in your stomach, esophagus or intestines ( gastrointestinal perforation ). This can lead to death.
If any of the above applies to you, contact your doctor immediately.
Other side effects include:
Very common (may affect more than 1 user in 10):
- reduction in red blood cell count ( anemia ) or white blood cell count (which are important in fighting infections )
- reduction in the number of platelets (which may increase the risk of bleeding)
- loss of appetite ( anorexia )
- upset stomach including nausea, vomiting, diarrhea or constipation
- back pain
- blood in the urine
- fatigue, weakness or lack of energy
Common (may affect up to 1 in 10 people):
- taste change
- shortness of breath
- cough
- abdominal pain
- temporary hair loss (after the end of treatment, normal hair growth should in most cases return)
- joint pain
- urinary tract infection
- lack of white blood cells associated with fever and infection
- numbness or tingling, burning or decreased sensation in hands and feet
- dizziness
- headache
- increased or decreased blood pressure
- feeling of discomfort in the stomach, heartburn or belching
- abdominal pain
- hemorrhoids
- muscle spasms
- painful or frequent urination
- urinary incontinence
- kidney disease or problems
- sores in the mouth or on the lips
- infection you or a risk of infection s
- high blood sugar
- insomnia
- mental confusion
- anxiety
- numbness or pain in hands and feet
- balance problem
- fast or irregular heartbeat
- blood clot in bone or lung
- flaming skin
- pain in mouth or throat
- rectal bleeding
- muscle aches, excruciating pain, feeling of weakness or pain
- swelling of t5he feet or legs
- overindulge
Uncommon (may affect up to 1 in 100 people):
- low blood potassium
- earring
- feeling of warmth in the skin
- reddening of the skin
- nail disease (change in nail color; nails may come off)
- inflammation of the bladder that can occur when exposed to radiation therapy (cystitis due to “radiation recall phenomenon”)
Has been reported (occurs in an unknown number of users):
- interstitial lung disease (pneumonia with cough and difficulty breathing).
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
How to store JEVTANA
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and the inner label of the vials after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in a cold place.
Information on storage and use time after dilution of J EVTANA is described in the section “Practical information for healthcare professionals for the preparation, administration, and handling of jevtana”.
Any unused product or waste material should be disposed of by local requirements. These measures will help to protect the environment.
Contents of the pack and other information
JEVTANA contains
The active substance is cabazitaxel. One ml of concentrate contains 40 mg of cabazitaxel. Each vial of concentrate contains 60 mg cabazitaxel.
The other ingredients are polysorbate 80 and citric acid in the concentrate and ethanol 96% and water for injections in the diluent (see section 2 “J EVTANA contains alcohol”).
Note: Both J EVTANA 60 mg / 1.5 ml concentrate vial (filling volume: 73.2 mg cabazitaxel / 1.83 ml) and the diluent vial (filling volume: 5.67 ml) contain an overfill to compensate for fluid loss during preparation. This overfill ensures that after dilution with the ENTIRE content of the supplied diluent, a solution containing 10 mg/ml cabazitaxel is obtained.
What the medicine looks like and contents of the pack
J EVTANA is a concentrate and diluent for solution for infusion (sterile concentrate).
The concentrate is a clear, yellow to the brownish-yellow oily solution.
The diluent is a clear and transparent solution.
A pack of J EVTANA contains:
- A transparent vial of single use glass with a gray rubber stopper sealed with an aluminum cap covered with a light green «flip-off” plastic -kapsyl, containing 1.5 ml (nominal volume) concentrate
- A transparent vial of single use glass with a gray rubber stopper sealed with a gold-colored aluminum cap covered with a transparent «flip-off” plastic -kapsyl containing 4.5 ml (nominal volume) solvent .
Marketing Authorisation Holder
sanofi-aventis groupe
54, rue La Boétie
F-75008 Paris
France
Manufacturer
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst
65926 Frankfurt am Main
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
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