TEROPROS FILM COATED TABLET 500MG [SIN16278P]

Product Info

TEROPROS FILM COATED TABLET 500MG

[SIN16278P]

4.1 Therapeutic indications

TEROPROS 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 section 5.1 – 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.

4.2 Posology and method of administration

Dosage
TEROPROS is for oral use. The recommended dosage is 1000 mg as a single daily dose that must not be taken with food. Abiraterone acetate must be taken as a single dose once daily on an empty stomach. Abiraterone acetate must be taken at least two hours after eating and food must not be eaten for at least one hour after taking abiraterone acetate. Taking the tablets with food increases systemic exposure to abiraterone. The tablets must be swallowed with water (see section 5.2 – Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If splitting the 1000 mg tablet is necessary to facilitate swallowing, break the tablet using a dedicated pill cutter, only at the moment of administration. Swallow both generated halves of the tablet consecutively at the same moment without chewing.

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 acetate is used with 5 mg prednisone or prednisolone daily.

For metastatic castration-resistant prostate cancer (mCRPC), abiraterone acetate 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 section 4.4 – 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 acetate, 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 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.

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 acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). No dose adjustment can be predicted. abiraterone acetate should be used with caution in patients with moderate hepatic impairment, only if the benefit clearly outweighs the possible risk (see section 4.4 – Hepatotoxicity and Hepatic impairment and 5.2 – Special populations – 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 section 4.4 – Hepatotoxicity and Hepatic impairment and 5.2 – 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 section 4.4 – 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 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 section 4.2 – 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 acetate.

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 (see section 5.2 – 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 section 5.2 – 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 section 4.4 – 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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients (see 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 section 4.6 – 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 sections 4.2, 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)].