ABIRONE ABIRATERONE ACETATE TABLETS 250 MG [SIN16239P]

Product Info

ABIRONE ABIRATERONE ACETATE TABLETS 250 MG

[SIN16239P]

THERAPEUTIC INDICATIONS

Abiraterone Acetate tablets 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).

• The treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• The treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Dosage and Administration

Dosage

The recommended dosage is 1000 mg (two 500 mg tablets or four 250 mg tablets) as a single daily dose that must not be taken with food. Abiraterone tablets must be taken on an empty stomach, at least one hour before or at least two hours after a meal. Taking the tablets with food increases systemic exposure to abiraterone. The tablets should be swallowed whole with water (see Pharmacokinetic Properties – Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Medical castration with LHRH analogue should be continued during treatment in patients not surgically castrated.

Dosage of prednisone or prednisolone

For metastatic hormone-sensitive prostate cancer (mHSPC), Abiraterone is used with 5 mg prednisone or prednisolone daily.

For metastatic castration-resistant prostate cancer (mCRPC), Abiraterone is used with 10 mg prednisone or prednisolone daily.

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 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 (see Warnings and Precautions – Hypertension, hypokalemia, fluid retention and cardiac failure due to mineralocorticoid excess and Hepatotoxicity and Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients with pre-existing hypokalemia or those that develop hypokalemia 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, hypokalemia, 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.

Hepatic impairment

No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A. There are no data on the clinical safety and efficacy of multiple doses of Abiraterone when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). No dose adjustment can be predicted. Abiraterone should be used with caution in patients with moderate hepatic impairment, only if the benefit clearly outweighs the possible risk (see Warnings and Precautions – Hepatotoxicity and Hepatic impairment and Pharmacokinetic Properties – Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Abiraterone should not be used in patients with severe hepatic impairment (see Warnings and Precautions – Hepatotoxicity and Hepatic impairment and Pharmacokinetic Properties – Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For patients who develop hepatotoxicity during treatment (alanine aminotransferase (ALT) increases or aspartate aminotransferase (AST) increases above 5 times the upper limit of normal, treatment should be withheld immediately until liver function tests normalize (see Warnings and Precautions – Hepatotoxicity and Hepatic impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Re-treatment following return of liver function tests to the patient's baseline may be given at a reduced dose of 500 mg (one 500 mg tablet or two 250 mg 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. Reduced doses should not be taken with food (see Dosage and Administration – Dosage).

If patients develop severe hepatotoxicity (ALT or AST 20 times the upper limit of normal) anytime while on therapy, treatment should be discontinued and patients should not be re-treated with Abiraterone.

Moderate hepatic impairment (Child-Pugh Class B) has been shown to increase the systemic exposure to abiraterone by approximately four-fold following single oral doses of Abiraterone 1,000 mg (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dosage adjustment is necessary for patients with renal impairment (see Pharmacokinetic Properties – Special populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, there is no clinical experience in patients with prostate cancer and severe renal impairment. Caution is advised in these patients (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

There is no relevant use of this medicinal product in the paediatric population, as prostate cancer is not present in children and adolescents.

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to other bisphosphonates or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Women who are or may potentially be pregnant (see Pregnancy, Breast-feeding and Fertility – Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Severe hepatic impairment [Child-Pugh Class C (see Dosage and Administration, Warnings and Precautions and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)]