BIRATO 250 ABIRATERONE ACETATE TABLET USP 250MG

Therapeutic indications

Abiraterone Acetate is indicated with prednisone or prednisolone for:

• The treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 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 in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients – 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 section Fertility, pregnancy and lactation – 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 sections Posology and method of administration, Special warnings and precautions for use and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)].

Posology and method of administration

This medicinal product should be prescribed by an appropriate healthcare professional.

Posology

The recommended dose is 1,000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). Taking the tablets with food increases systemic exposure to abiraterone (see sections Interaction with other medicinal products and forms of Interaction and Pharmacokinetics properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Abiraterone Acetate is to be taken with low dose prednisone or prednisolone. The recommended dose of prednisone or prednisolone is 10 mg daily.

Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated.

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 section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In patients with pre-existing hypokalaemia or those that develop hypokalaemia whilst being treated with Abiraterone Acetate , consider maintaining the patient’s potassium level at ≥ 4.0 mM.

For patients who develop Grade ≥ 3 toxicities including hypertension, hypokalaemia, oedema and other nonmineralocorticoid 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 Acetate , prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose.

Hepatotoxicity

For patients who develop hepatotoxicity during treatment (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section Special warnings and precautions for use – 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 (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.

Hepatic impairment

No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A. 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 acetate 1,000 mg. 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). No dose adjustment can be predicted. The use of Abiraterone Acetate should be cautiously assessed in patients with moderate hepatic impairment, in whom the benefit clearly should outweigh the possible risk (see sections Posology and method of administration and pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Abiraterone Acetate should not be used in patients with severe hepatic impairment (see sections Contraindications, Special warnings and precautions for use and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dose adjustment is necessary for patients with renal impairment (see section Pharmacokinetic properties – 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 section Special warnings and precautions for use – 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 Abiraterone Acetate in the paediatric population.

Method of administration

Abiraterone Acetate Tablets is for oral use.

The tablets should be taken at least two hours after eating and no food should be eaten for at least one hour after taking the tablets. These should be swallowed whole with water.