Patient Medication Information: uses, side effects, how to take - Apo-Abiraterone Acetate Film Coated Tablets
ABOUT THIS MEDICATION
What the medication is used for:
APO-ABIRATERONE ACETATE FILM COATED TABLETS, in combination with prednisone, is used to treat prostate cancer that has spread to other parts of the body in:
adult patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT).
or
adult patients who have had prior cancer treatment with docetaxel after failure of ADT.
or
- adult patients with newly diagnosed hormone-sensitive high-risk prostate cancer who may have received up to 3 months of prior ADT.
Asymptomatic patients are defined as patients who may have no noticeable changes to health. Mildly symptomatic patients may show symptoms or changes in health such as bone pain or fatigue.
What it does:
APO-ABIRATERONE ACETATE FILM COATED TABLETS works to stop your body from making androgens. This can slow the growth of prostate cancer. APO-ABIRATERONE ACETATE FILM COATED TABLETS may help delay the decline in your daily activity levels and may help delay the need for drugs to treat your cancer pain.
When your prostate cancer spreads beyond the prostate to other parts of the body, this is known as metastatic prostate cancer or advanced cancer.
Androgens are a group of hormones, and testosterone belongs to this group. Testosterone is the main type of androgen. Androgens promote cancer cell growth. That is why it’s so important to keep these hormones at “castrate levels” (extremely low levels), to stop the growth of cancer.
APO-ABIRATERONE ACETATE FILM COATED TABLETS helps to block the production of even small amounts of androgens in the three places they are produced: in the testes, the adrenal glands and the prostate cancer tumor itself.
When it should not be used:
- If you are allergic (hypersensitive) to abiraterone acetate or any of the other ingredients of APO-ABIRATERONE ACETATE FILM COATED TABLETS.
APO-ABIRATERONE ACETATE FILM COATED TABLETS should not be taken by women who are pregnant or might be pregnant.
- APO-ABIRATERONE ACETATE FILM COATED TABLETS should not be taken by women who are nursing.
What the medicinal ingredient is:
Abiraterone acetate (of Abiraterone Acetate, as is)
What the non-medicinal ingredients are:
APO-ABIRATERONE ACETATE FILM COATED TABLETS 500 mg film-coated tablets: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Tablet film-coating: ferric oxide red, iron oxide black, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
What dosage form it comes in:
500 mg film-coated tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
|
APO-ABIRATERONE ACETATE FILM COATED TABLETS must be taken on an empty stomach since food can increase the blood level of APO-ABIRATERONE ACETATE FILM COATED TABLETS and this may be harmful. Do not eat any solid or liquid food two hours before taking APO-ABIRATERONE ACETATE FILM COATED TABLETS and at least one hour after taking APO-ABIRATERONE ACETATE FILM COATED TABLETS.
BEFORE you use APO-ABIRATERONE ACETATE FILM COATED TABLETS talk to your doctor or pharmacist if:
- you have or have had high blood pressure, low blood potassium and irregular heartbeats
- you have diabetes
- you have or have had heart failure, heart attack, or other heart problems
- you have liver problems
- you have or have had adrenal problems
APO-ABIRATERONE ACETATE FILM COATED TABLETS may affect your liver. Rarely, failure of the liver to function (called acute liver failure) may occur, which can lead to death. Talk to your doctor if you develop yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. When you are taking APO-ABIRATERONE ACETATE FILM COATED TABLETS your doctor will check your blood to look for any effects of APO-ABIRATERONE ACETATE FILM COATED TABLETS on your liver.
APO-ABIRATERONE ACETATE FILM COATED TABLETS may affect your blood sugar levels if you have diabetes. Your blood sugar might drop if you take APO-ABIRATERONE ACETATE FILM COATED TABLETS plus prednisone/prednisolone with drugs for diabetes, like pioglitazone or repaglinide. Your physician will check your blood sugar levels while you are taking these drugs with APO-ABIRATERONE ACETATE FILM COATED TABLETS plus prednisone/prednisolone.
APO-ABIRATERONE ACETATE FILM COATED TABLETS may harm an unborn baby. While taking APO-ABIRATERONE ACETATE FILM COATED TABLETS and for one week after the last dose of APO-ABIRATERONE ACETATE FILM COATED TABLETS, male patients must use a condom and another effective birth control method when having sexual activity with a woman who is pregnant or can become pregnant.
Women who are pregnant or may become pregnant should not handle APO-ABIRATERONE ACETATE FILM COATED TABLETS without protective gloves.
APO-ABIRATERONE ACETATE FILM COATED TABLETS should not be used in patients under 18 years of age.
INTERACTIONS WITH THIS MEDICATION
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Tell your physician if you are taking phenytoin, carbamazepine, rifampicin, rifabutin, phenobarbital, or St. John’s wort because these medications may decrease the effect of APO-ABIRATERONE ACETATE FILM COATED TABLETS. This may lead to APO-ABIRATERONE ACETATE FILM COATED TABLETS not working as well as it should.
Tell your physician if you are taking drugs for diabetes, like pioglitazone or repaglinide. Your blood sugar might drop if you take these drugs with APO-ABIRATERONE ACETATE FILM COATED TABLETS plus prednisone/prednisolone.
PROPER USE OF THIS MEDICATION
Always take APO-ABIRATERONE ACETATE FILM COATED TABLETS exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Usual dose:
The usual dose is two 500 mg tablets (1g) by mouth once a day.
APO-ABIRATERONE ACETATE FILM COATED TABLETS must be taken on an empty stomach
- Do not eat any solid or liquid food two hours before taking APO-ABIRATERONE ACETATE FILM COATED TABLETS and at least one hour after taking APO-ABIRATERONE ACETATE FILM COATED TABLETS. Taking APO-ABIRATERONE ACETATE FILM COATED TABLETS with food causes more of this medicine to be absorbed by the body than is needed and this may be harmful.
- Swallow the tablets whole with a glass of water.
- Do not break the tablets.
- APO-ABIRATERONE ACETATE FILM COATED TABLETS is taken with a medicine called prednisone to help manage potential side effects such as fluid in your legs or feet and muscle
- weakness, muscle twitches or a pounding heart beat (palpitations) which may be signs of low blood potassium (see Side Effects section below). Take the prednisone exactly as your doctor has told you.
Overdose:
| If you think you have taken too much APO-ABIRATERONE ACETATE FILM COATED TABLETS, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed dose:
If you forget to take APO-ABIRATERONE ACETATE FILM COATED TABLETS or prednisone, take your normal dose the following day.
If you forget to take APO-ABIRATERONE ACETATE FILM COATED TABLETS or prednisone for more than one day, talk to your doctor without delay.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, APO-ABIRATERONE ACETATE FILM COATED TABLETS can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Very Common (affects more than 1 in 10 people):
- Joint swelling or pain, muscle pain
- Hot flushes
- Cough
- Diarrhea
- Fatigue
- Constipation
- Vomiting
- Insomnia
- Anemia
- High blood pressure
Common (affects less than 1 in 10 people):
- High fat levels in your blood
- Liver function test increases
- Heart failure
- Rapid or irregular heart rate associated with feeling faint or lightheaded
- Upper and lower respiratory infection
- Stomach upset / Indigestion
- Flu-like symptoms
- Weight increase
- Urinary frequency
- Bone break (fracture)
Presence of blood in your urine
- Rash and skin lesions
- Falls
- Bruising
- Headache
- Depression
Uncommon (affects less than 1 in 100 people):
- Adrenal gland problems
Reported from post-marketing with unknown frequency
- Lung irritation - Symptoms may include shortness of breath, cough and fatigue.
Reported from post-marketing with very rare frequency
- Anaphylactic-allergic reactions
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Your blood pressure, blood sugar, serum potassium, signs and symptoms of fluid retention will be monitored clinically by your doctor.
| SERIOUS SIDE EFFEC TS, HOW OFTEN THEY HAPPEN 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 | |||||
| Very Common | ||||||
| Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs of low level of potassium in your blood. | √ | |||||
| Swollen hands, legs, ankles or feet | √ | |||||
| Burning on urination or cloudy urine (Urinary tract infection) | √ | |||||
| Common | ||||||
| Chest pain | √ | |||||
| Irregular heartbeat (heart beat disorder) that can be associated with feeling faint, lightheaded, chest pain, a racing heartbeat, a slow heartbeat, shortness of breath, sweating, or a fluttering in your chest. | √ | |||||
| Rapid heart rate | √ | |||||
| Unknown | |||
| Shortness of breath | √ | ||
| Breakdown of muscle tissue and muscle weakness and/or muscle pain | √ | ||
| Yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting (Failure of the liver to function/ acute liver failure) | √ | ||
Allergic reactions that include, but are not limited to difficulty swallowing or breathing, swollen face or lips, tongue or throat, or an itchy rash called urticaria. | √ | ||
| Very Rare | |||
Thirst, frequent urination, hunger, nausea and dizziness, fast heartbeat, tingling trembling, nervousness, sweating, low energy (low blood sugar) | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-ABIRATERONE ACETATE FILM COATED TABLETS, contact your doctor or pharmacist.
HOW TO STORE IT
APO-ABIRATERONE ACETATE FILM COATED TABLETS should be stored at room temperature 15ºC to 30ºC. Keep out of the reach and sight of children.
Do not use APO-ABIRATERONE ACETATE FILM COATED TABLETS after the expiry date which is stated on the label. The expiry date refers to the last day of the month.
Medicines should not be thrown away via wastewater or household waste. Throw away any unused product or waste material in accordance with local requirements. If you are not sure, ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
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. |
MORE INFORMATION
If you want more information about APO-ABIRATERONE ACETATE FILM COATED TABLETS:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this consumer information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.