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Abiraterone Accord is a brand name for Abiraterone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Abiraterone Accord is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) • the treatment of metastatic castration resistant prostate cancer…
Verbatim from this product's EMA label. Tap a section to expand.
This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below).
2). Dosage of prednisone or prednisolone For mHSPC, Abiraterone Accord is used with 5 mg prednisone or prednisolone daily. For mCRPC, Abiraterone Accord is used with 10 mg prednisone or prednisolone daily. Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.
Recommended monitoring Serum transaminases should be measured prior to starting treatment, every two weeks for the first three months of treatment and monthly thereafter. Blood pressure, serum potassium and fluid retention 3 should be monitored monthly.
4). 0 mM. For patients who develop Grade ≥ 3 toxicities including hypertension, hypokalaemia, oedema and other non-mineralocorticoid toxicities, treatment should be withheld and appropriate medical management should be instituted. Treatment with abiraterone acetate should not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline.
In the event of a missed daily dose of either Abiraterone Accord, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose. 4). Re-treatment following return of liver function tests to the patient’s baseline may be given at a reduced dose of 500 mg (two tablets) once daily.
For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for three months and monthly thereafter. If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated. 2). However, there is no clinical experience in patients with prostate cancer and severe renal impairment.
4). Hepatic impairment No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A. 2). There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C).
Summary of the safety profile In an analysis of adverse reactions of composite Phase 3 studies with abiraterone acetate, adverse reactions that were observed in ≥10% of patients were peripheral oedema, hypokalaemia, hypertension, urinary tract infection, and alanine aminotransferase increased and/or aspartate aminotransferase increased.
Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis. Abiraterone acetate may cause hypertension, hypokalaemia and fluid retention as a pharmacodynamic consequence of its mechanism of action.
In Phase 3 studies, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with abiraterone acetate than in patients treated with placebo: hypokalaemia 18 % vs. 8 %, hypertension 22 % vs. 16 % and fluid retention (peripheral oedema) 23 % vs.
17 %, respectively. 0) Grades 3 and 4 hypertension were observed in 7 % versus 5 %, and fluid retention (peripheral oedema) Grades 3 and 4 were observed in 1 % versus 1 % of patients, respectively. Mineralocorticoid reactions generally were able to be successfully managed medically.
4). Tabulated list of adverse reactions In studies of patients with metastatic advanced prostate cancer who were using an LHRH analogue, or were previously treated with orchiectomy, abiraterone acetate was administered at a dose of 1000 mg daily in combination with low dose prednisone or prednisolone (either 5 or 10 mg daily depending on the indication).
Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
1). Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in incidence and severity of these adverse reactions. , those with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment).
Abiraterone acetate should be used with caution in patients with a history of cardiovascular disease. The Phase 3 studies conducted with abiraterone acetate excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class (NYHA) III or IV heart failure (study 301) or Class II to IV heart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
In studies 3011 and 302, patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded. 1). g. echocardiogram). Before treatment with abiraterone acetate , cardiac failure should be treated and cardiac function optimised.
Hypertension, hypokalaemia and fluid retention should be corrected and controlled. During treatment, blood pressure, serum potassium, fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure should be monitored every 2 weeks for 3 months, then monthly thereafter and abnormalities corrected.
QT prolongation has been observed in patients experiencing hypokalaemia in association with abiraterone acetate treatment. 2). 8). Serum transaminase levels should be measured prior to starting treatment, every two weeks for the first three months of treatment, and monthly thereafter.
If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases should be measured immediately. If at any time the ALT or AST rises above 5 times the ULN, treatment should be interrupted immediately and liver function closely monitored.
1. 6). 2)]. 4 - Abiraterone acetate with prednisone or prednisolone is contraindicated in combination with Ra- 223.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No dose adjustment can be predicted. 2). 2). Paediatric population There is no relevant use of abiraterone acetate in the paediatric population. Method of administration Abiraterone Accord is for oral use. The tablets should be taken at least one hour before or at least two hours after eating.
These should be swallowed whole with water.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 5) Vascular disorders very common: hypertension Respiratory, thoracic and mediastinal disorders rare: allergic alveolitisa Gastrointestinal disorders very common: diarrhoea common: dyspepsia Hepatobiliary disorders very common: alanine aminotransferase increased and/or aspartate aminotransferase increased b rare: hepatitis fulminant, acute hepatic failure Skin and subcutaneous tissue disorders common: rash Musculoskeletal and connective tissue disorders uncommon: myopathy, rhabdomyolysis Renal and urinary disorders common: haematuria General disorders and administration site conditions very common: oedema peripheral Injury, poisoning and procedural complications common: fractures** * Cardiac failure also includes congestive heart failure, left ventricular dysfunction and ejection fraction decreased ** Fractures includes osteoporosis and all fractures with the exception of pathological fractures a Spontaneous reports from post-marketing experience b Alanine aminotransferase increased and/or aspartate aminotransferase increased includes ALT increased, AST increased, and hepatic function abnormal.
0) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 5%; urinary tract infection 2%; alanine aminotransferase increased and/or aspartate aminotransferase increased 4%; hypertension 6%; fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each.
0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients. 0) Grade 4 urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, hypokalemia, cardiac failure, atrial fibrillation, and fractures occurred in < 1% of patients.
A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 3011). 2% in studies 301 and 302, respectively. 9% in 301 and 302, respectively). The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG 2 performance status grade and also in elderly patients (≥75 years).
Description of selected adverse reactions Cardiovascular reactions The three Phase 3 studies excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart failure (study 301) or Class II to IVheart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
All patients enrolled (both active and placebo-treated patients) were concomitantly treated with androgen deprivation therapy, predominantly with the use of LHRH analogues, which has been associated with diabetes, myocardial infarction, cerebrovascular accident and […]
2). If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated. Patients with active or symptomatic viral hepatitis were excluded from clinical trials; thus, there are no data to support the use of Abiraterone Accord in this population.
There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). 2). 2). 8). Corticosteroid withdrawal and coverage of stress situations Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone.
If abiraterone acetate is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess (see information above). In patients on prednisone or prednisolone who are subjected to unusual stress, an increased dose of corticosteroids may be indicated before, during and after the stressful situation.
Bone density Decreased bone density may occur in men with metastatic advanced prostate cancer. The use of abiraterone acetate in combination with a glucocorticoid could increase this effect. Prior use of ketoconazole Lower rates of response might be expected in patients previously treated with ketoconazole for prostate cancer.
Hyperglycaemia The use of glucocorticoids could increase hyperglycaemia, therefore blood sugar should be measured frequently in patients with diabetes. 5); therefore, blood sugar should be monitored in patients with diabetes. Use with chemotherapy The safety and efficacy of concomitant use of abiraterone acetate with cytotoxic chemotherapy has not been established […]