Apo-Abiraterone

Abiraterone acetate

Excipients/Inactive Ingredients: 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.

APO-ABIRATERONE TABLETS works to stop the body from making a type of hormone called androgens. Androgens promote cancer cell growth. Therefore, APO-ABIRATERONE TABLETS can help slow the growth of prostate cancer.

APO-ABIRATERONE TABLETS, is used with a drug called prednisone to treat adults with prostate cancer that has spread to other parts of the body. These adults must have: Mild or no symptoms after treatment with androgen deprivation therapy (ADT) that does not work; or had cancer treatment with a drug called docetaxel after treatment of ADT that does not work.

Advise patient to take exactly as prescribed, and to check with a healthcare professional if not sure.
Take on an empty stomach. Do not eat any solid or liquid food two hours before taking APO-ABIRATERONE TABLETS and at least one hour after taking APO-ABIRATERONE TABLETS. Taking APO-ABIRATERONE TABLETS with food may be harmful.
Swallow tablets whole with water. Do not break the APO-ABIRATERONE TABLETS.
Take APO-ABIRATERONE TABLETS for as long as prescribed. Patient must not stop taking this medicine unless advised to.
Monitor patient's health. Interrupt, reduce or stop the dose based on patient's current health if he takes certain other medications or if he has certain side effects.
Advise patient to take prednisone exactly as prescribed.
Usual dose: Recommended adult dose: 1000 mg per day. To make this dose, take two 500 mg tablets or four 250 mg tablets once per day.
The patient will also receive treatment with another medicine, prednisone. Advise patient how much of this medicine to take and how to take it.
Missed dose: If patient misses a dose of APO-ABIRATERONE TABLETS or prednisone, skip the missed dose. Take the next dose at the usual time on the next day.
If patient misses more than one dose of APO-ABIRATERONE TABLETS or prednisone, advise him to talk to a healthcare professional right away.

In case of taking too much APO-ABIRATERONE TABLETS, advise patient to contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Patient must not use APO-ABIRATERONE TABLETS if he is allergic to abiraterone acetate or any of the other ingredients of APO-ABIRATERONE TABLETS or the container; in women who are pregnant or might be pregnant or is breastfeeding.

APO-ABIRATERONE TABLETS may cause hypertension (high blood pressure), hypokalemia (low blood potassium) and peripheral edema (swelling of the legs or hands caused by fluid retention). These will need to be treated before starting APO-ABIRATERONE TABLETS. Perform monthly tests to check these problems.
Be advised if patient has a history of heart failure, heart attack, or other heart problems. This will help avoid side effects and ensure proper use of APO-ABIRATERONE TABLETS.
If patient has moderate to serious liver problems, he should not take APO-ABIRATERONE TABLETS.
APO-ABIRATERONE TABLETS may cause liver failure, sometimes causing death.

To help avoid side effects and ensure proper use, advise patient to talk to a healthcare professional before taking APO-ABIRATERONE TABLETS. Be advised of any health conditions or problems he may have, including if he: has or has had high blood pressure, low blood potassium and irregular heartbeats; has diabetes; has or has had heart failure, heart attack, artery blood clots or other heart problems; has liver problems; has or has had adrenal (hormonal) problems; will have surgery or had surgery; has or had severe trauma or infections.
APO-ABIRATERONE TABLETS must be taken on an empty stomach since food can increase the blood level of APO-ABIRATERONE TABLETS and this may be harmful. Do not eat any solid or liquid food two hours before taking APO-ABIRATERONE TABLETS and at least one hour after taking APO-ABIRATERONE TABLETS.
Liver Problems: APO-ABIRATERONE TABLETS can cause liver failure which can lead to death. Advise patient to talk to a healthcare professional if he has yellowing of the skin or eyes, dark urine, or serious nausea or vomiting. These could be signs or symptoms of liver problems.
Perform regular blood tests before starting APO-ABIRATERONE TABLETS, every two weeks for the first three months while taking APO-ABIRATERONE TABLETS, and every month after. These blood tests will tell how the liver is working.
Low blood sugar (hypoglycemia): APO-ABIRATERONE TABLETS may affect the blood sugar levels if the patient has diabetes. The blood sugar might drop if he takes APO-ABIRATERONE TABLETS plus prednisone/prednisolone with drugs for diabetes, like pioglitazone or repaglinide. Check the blood sugar levels.
Muscle problems: APO-ABIRATERONE TABLETS might cause muscle problems including break down of damaged muscle (rhabdomyolysis). This can cause kidney failure.
See Serious side effects and their symptoms under Side Effects for more information on these and other serious side effects.
Check-ups and testing: Advise patient to regularly visit a healthcare professional, before, during and at the end of his treatment: Check his blood pressure; Do blood tests and physical exams.
Use in Children: APO-ABIRATERONE TABLETS should not be used in patients under 18 years of age.

Fertility and Sexual Health: Male patients: During treatment with ABIRATERONE TABLETS, patient must use a condom along with another effective birth control method each time he has sex with a woman who is pregnant, may be pregnant or could get pregnant. Continue using condoms until 1 week after the last dose.
If, during the treatment with ABIRATERONE TABLETS, his sexual partner becomes pregnant or thinks she may be pregnant, advise patient to tell a healthcare professional right away.
Male patients - fertility: Treatment with ABIRATERONE TABLETS may affect the ability to father a child. Patient must talk to a healthcare professional if he has questions about this.
Females: APO-ABIRATERONE TABLETS are not for use in women.
APO-ABIRATERONE TABLETS may harm an unborn baby.
Women who are pregnant or may be pregnant should not handle Abiraterone tablets without protective gloves

These are not all the possible side effects the patient may have when taking APO-ABIRATERONE TABLETS. Advise patient to tell a healthcare professional if he experiences any side effects not listed: Joint swelling or pain, muscle pain; Hot flushes; Cough; Diarrhea; Fatigue; Constipation; Vomiting; Insomnia; High blood pressure; Stomach upset/Indigestion; Flu-like symptoms; Weight gain; Frequent urination; Blood in urine; Bone fractures including ribs; Rash and skin wounds; Falls; Bruising; Headache; Depression.
Perform blood tests, check the blood pressure and monitor patient's health during treatment. These will tell how APO-ABIRATERONE TABLETS is affecting the blood, blood sugar, adrenal system and liver.
Serious side effects and their symptoms: Very Common: Anemia (decreased number of red blood cells): Fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness.
Hypertension (high blood pressure): Shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in the ankles and legs, bluish colour to the lips and skin, racing pulse or heart palpitations.
Hypokalemia (low level of potassium in the blood): Muscle weakness, muscle twitches or a pounding heartbeat, cramping, constipation, fatigue, tingling or numbness.
Peripheral edema (swelling of legs or hands caused by fluid retention): Swollen hands, legs, ankles or feet.
Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Burning or pain during urination, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine.
Common: Angina (not enough oxygen to the heart muscle): Discomfort in the shoulder, arm, back, throat, jaw or teeth; pain or pressure in the chest.
Arrhythmias, including QT prolongation and Torsades de Pointes (irregular heartbeat disorders): Feeling faint, lightheaded, chest pain, a racing heartbeat, a slow heartbeat, shortness of breath, sweating, weakness seizures, or a fluttering in the chest.
Heart failure (heart does not pump blood as well as it should): Shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise.
Pneumonia (infection in the lungs): Chest pain when breathing or coughing, confusion, cough which may produce phlegm, fatigue, fever, sweating and shaking chills, nausea, vomiting or diarrhea, shortness of breath.
Tachycardia (rapid heart rate).
Uncommon: Adrenal effects: Body aches, fatigue, low blood pressure, light-headedness, loss of body hair, skin discolouration, unexplained weight loss.
Very Rare:Hypoglycemia (low blood sugar): Thirst, frequent urination, hunger, nausea and dizziness, fast heartbeat, tingling trembling, nervousness, sweating, low energy.
Unknown: Allergic alveolitis (lung allergic reaction): Shortness of breath, cough, fatigue, chills, sweating.
Dyspnea (shortness of breath).
Rhabdomyolysis (breakdown of damaged muscle): Muscle weakness, muscle pain, muscle spasms, red-brown coloured urine.
Liver Failure (serious disturbance of liver function): Yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, confusion, fatigue.
Severe allergic reactions includes, but are not limited to difficulty swallowing or breathing, swollen face or lips, tongue or throat, or an itchy rash called urticaria.
Advise patient to tell a healthcare professional if he has a troublesome symptom or side effect that is not listed or becomes bad enough to interfere with his daily activities.

Be advised about all the medicines the patient is taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-ABIRATERONE TABLETS: medicines typically used to treat epilepsy (seizures) such as phenytoin, carbamazepine, phenobarbital; medicines to treat bacterial infections such as rifampicin, rifabutin; an herbal treatment for depression called St. John's wort; medicines used to treat diabetes, such as pioglitazone, repaglinide; a medicine used to relieve coughs such as dextromethorphan.

APO-ABIRATERONE TABLETS should be stored below 25°C.
Do not throw away any drugs via wastewater or household waste. Ask the pharmacist how to throw away drugs no longer in use.

Cancer Hormone Therapy

L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.

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