Side Effects for ABIRATAJ

Prostate and other male cancers

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Abiraterone Acetate Tablet and see a doctor immediately if you notice any of the following: - Muscle weakness, muscle twitches or a pounding heart beat (palpitations). These may be signs that the level of potassium in your blood is low. Other side effects include: Very common (may affect more than 1 in 10 people): Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea. Common (may affect up to 1 in 10 people): High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash. Uncommon (may affect up to 1 in 100 people): Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain. Rare (may affect up to 1 in 1,000 people): Lung irritation (also called allergic alveolitis). Failure of the liver to function (also called acute liver failure). Not known (frequency cannot be estimated from the available data): Heart attack, changes in ECG - electrocardiogram (QT prolongation). Bone loss may occur in men treated for prostate cancer. Abiraterone Acetate Tablet in combination with prednisone or prednisolone may increase bone loss. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: In the UK, you can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. In Ireland, you can also report side effects directly via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, E-mail: medsafety@hpra.ie In Malta, report side effects to: ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

Indications

Abirataj is indicated in combination with prednisone for the treatment of patients with • Metastatic castration-resistant prostate cancer (CRPC) • Metastatic high-risk castration-sensitive prostate cancer (CSPC)

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Dosage

Recommended Dose For Metastatic CRPC
The recommended dose of abirataj is 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.

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Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.. Stop taking Abiraterone Acetate Tablet and see a doctor immediately if you notice any of the following side effects.

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Drug Interactions

Drugs That Inhibit Or Induce CYP3A4 Enzymes
In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%.

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Precautions

Abirataj may cause hypertension, hypokalemia, and fluid retention increased mineralocorticoid levels resulting from CYP17 inhibition.Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month.

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Pharmacology

Mechanism Of Action
Abiraterone acetate (Abirataj) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).

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