Active Ingredient: Abiraterone
Abiraterone 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).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
1,000 - 1,000 mg
From 1,000 To 1,000 mg once every day
The recommended dose is 1,000 mg as a single daily dose that must not be taken with food. Taking the tablets with food increases systemic exposure to abiraterone.
For mHSPC, abiraterone is used with 5 mg prednisone or prednisolone daily.
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 should be monitored monthly. However, patients with a significant risk for congestive heart failure should be monitored every 2 weeks for the first three months of treatment and monthly thereafter.
In patients with pre-existing hypokalaemia or those that develop hypokalaemia whilst being treated with abiraterone, consider maintaining the patient’s potassium level at ≥ 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 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, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose.
Abiraterone should be taken at least one hour before or at least two hours after eating. These should be swallowed whole with water.
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