500 mg film-coated tablets
abiraterone acetate
What ZYTIGA is and what it is used for
ZYTIGA contains a medicine called abiraterone acetate. It is used to treat adult men for prostate cancer that has spread to other parts of the body. ZYTIGA causes your body to stop producing testosterone. It can slow down the growth of prostate cancer.
When ZYTIGA is prescribed for the early stage of the disease where the disease is still responding to hormone therapy, it is used together with a treatment that lowers testosterone levels ( androgen deprivation therapy).
When you take this medicine, the doctor also prescribes another medicine called prednisone or prednisolone. This is done to reduce the risk of getting high blood pressure, too much water in the body ( fluid retention ), or reduced levels of the substance potassium in the blood.
What you need to know before you take ZYTIGA
Do not take ZYTIGA
- if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
- if you are a woman, especially not if you are pregnant. ZYTIGA should only be used by male patients.
- if you have severe liver damage.
- in combination with Ra-223 (used to treat prostate cancer).
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
- if you have liver problems
- if you have been told that you have high blood pressure or heart failure or low potassium in the blood (low potassium can increase the risk of heart rhythm problems)
- if you have had other heart or blood vessel problems
- if you have an irregular or fast pulse
- if you have shortness of breath
- if you have gained weight quickly
- if you have swollen feet, ankles, or legs
- if you have previously taken a medicine called ketoconazole for prostate cancer
- about the need to take this drug together with prednisone or prednisolone
- about how the drug can affect the skeleton
- if you have high blood sugar.
Tell your doctor if you have been told that you have heart or blood vessel disease, including heart rhythm problems ( arrhythmia ), or if you are being treated with medicines for these conditions.
Tell your doctor if you have yellowing of the skin or eyes, dark urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. In rare cases, the liver can stop working (called acute liver failure) which can lead to death.
Decreased number of red blood cells, decreased sex drive ( libido ), muscle weakness, and/or muscle pain may occur.
ZYTIGA must not be given in combination with Ra-223 due to a possible increased risk of bone fracture or death.
If you plan to take Ra-223 after treatment with ZYTIGA and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Blood test check
ZYTIGA can affect your liver without you having any symptoms. While you are taking this medicine, your doctor will check your blood at regular intervals to see if there are any effects on your liver.
Children and young people
This medicine is not intended for use by children and adolescents. Seek immediate medical attention if a child or young person accidentally takes ZYTIGA. Take the leaflet with you to show the doctor.
Other medicines and ZYTIGA
Talk to your doctor or pharmacist before taking any medicine.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because ZYTIGA can increase the effect of several medicines such as heart medicines, tranquilizers, some medicines for diabetes, (traditional) herbal medicines (eg St. John’s wort ), and other medicines. Your doctor may want to change the dose of one of these medicines. In addition, some medicines can increase or decrease the effect of ZYTIGA. This can lead to side effects or ZYTIGA not working as well as it should.
Androgen deprivation therapy (hormone therapy) increases the risk of heart rhythm problems. Tell your doctor if you are taking medicines such as:
- used to treat heart rhythm problems (eg, quinidine, procainamide, amiodarone, and sotalol)
- are known to increase the risk of heart rhythm problems [eg methadone (used for pain relief and detoxification in drug abuse), moxifloxacin (an antibiotic ), antipsychotics (used to treat serious mental illness)].
Tell your doctor if you are taking any of the medicines listed above.
ZYTIGA with food
- This medicine must not be taken with food (see section 3, “Taking the medicine”).
- Taking ZYTIGA together with food can cause side effects.
Pregnancy and breastfeeding
ZYTIGA is not intended for use by women.
- This medicine may harm the fetus if taken by women who are pregnant.
- If you have sex with a woman who could become pregnant, use a condom and another effective method of contraception.
- If you have sex with a pregnant woman, use a condom to protect the fetus.
Driving ability and use of machinery
This medicine is unlikely to affect your ability to drive and use tools or machines.
ZYTIGA contains lactose and sodium
- ZYTIGA contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
- This medicine contains 27 mg of sodium (the main ingredient in common/table salt) per daily dose consisting of two tablets. This is equivalent to 1.35% of the maximum recommended daily intake of sodium for adults.
How to take ZYTIGA
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended dose is 1,000 mg (two tablets) once a day.
Ingestion of the drug
- Take this medicine by mouth.
- Do not take ZYTIGA with food. Taking ZYTIGA with food can lead to a more significant amount of the medicine than necessary being absorbed by the body, which can cause side effects.
- Take ZYTIGA tablets as a single dose once daily on an empty stomach. ZYTIGA must be taken at least two hours after food, and do not eat for at least one hour after taking ZYTIGA (see section 2, “ZYTIGA with food”).
- Swallow the tablets whole with water.
- Do not split the tablets.
- ZYTIGA is taken together with a medicine called prednisone or prednisolone. Always take prednisone or prednisolone as directed by your doctor.
- You need to take prednisone or prednisolone every day while taking ZYTIGA.
- The amount of prednisone or prednisolone you take may need to be changed if you have a medical emergency. The doctor will tell you if you need to change the amount of prednisone or prednisolone that you take. Do not stop taking prednisone or prednisolone unless your doctor tells you to.
The doctor may also prescribe other medicines at the same time as you take ZYTIGA and prednisone or prednisolone.
If you have taken too much ZYTIGA
If you take more than you should, talk to a doctor or go to the hospital immediately.
If you forget to take ZYTIGA
- If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the next day.
- If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor right away.
If you stop taking ZYTIGA
Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop taking ZYTIGA and seek medical attention immediately if you notice any of the following:
- Muscle weakness, muscle twitching, or pounding heartbeats (palpitations). It may be a sign that the potassium level in your blood is low.
Other side effects:
Very common (may affect more than 1 in 10 users):
Fluid in the legs or feet, low potassium levels in the blood, elevated liver values, high blood pressure, urinary tract infection, diarrhea.
Common (may affect up to 1 in 10 users)
High levels of blood fats, chest pain, irregular heart rhythm (atrial fibrillation), heart failure, fast pulse, a serious infection called blood poisoning, bone fractures, indigestion, blood in the urine, and skin rash.
Uncommon (may affect up to 1 in 100 users):
Problems with the adrenal glands (related to problems with salt and water), abnormal heart rhythm ( arrhythmia ), muscle weakness, and/or muscle pain.
Rare (may affect up to 1 in 1,000 users):
Irritation of the lungs (also called allergic alveolitis)
Acute liver failure
Not known frequency (occurs in an unknown number of users):
Heart attack, changes in ECG ( QT prolongation), and severe allergic reactions with difficulty in swallowing or breathing swelling of the face, lips, tongue, or throat, or itchy rash.
Bone loss can occur in men treated for prostate cancer. ZYTIGA in combination with prednisone or prednisolone may increase bone loss.
How ZYTIGA should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton, folding packaging, and blister. The expiration date is the last day of the specified month.
- No special storage instructions.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
- Other ingredients are microcrystalline cellulose (with silicon dioxide), croscarmellose sodium, hypromellose 2910 (15 mPa.S), lactose monohydrate, magnesium stearate, colloidal anhydrous silica, and sodium lauryl sulfate (see section 2, “ZYTIGA contains lactose and sodium”). The film coating contains black iron oxide (E172), red iron oxide (E172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide.
Appearance and package sizes of the medicine
- ZYTIGA tablets are violet, oval in shape, and film-coated (20 mm long and 10 mm wide) with the text “AA” on one side and “500” on the other side. Each 28-day carton contains 56 film-coated tablets in 4 blister packs of 14 film-coated tablets each. Each 30-day carton contains 60 film-coated tablets in 5 blister packs of 12 film-coated tablets each.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
Janssen‑Cilag International NV
Turnhoutseweg 30
B‑2340 Beerse
Belgium
Manufacturer
Janssen‑Cilag SpA.
Via C. Janssen
Borgo San Michele
I-04100 Latina, Italy