ESTATIGA FILM COATED TABLETS 500MG [SIN17251P]

Product Info

ESTATIGA FILM COATED TABLETS 500MG

[SIN17251P]

Indication

4.1 Therapeutic indications

Estatiga 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 – 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 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 mCRPC in adult men whose disease has progressed on or after a docetaxel- based chemotherapy regimen.

Dosing

4.2 Posology and method of administration

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

Posology
The recommended dose is 1,000 mg (2× 500 mg tablet) 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 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage of prednisone or prednisolone
For mHSPC, Estatiga is used with 5 mg prednisone or prednisolone daily. For mCRPC, Estatiga 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 2 weeks for the first 3 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 3 months of treatment and monthly thereafter (see section 4.4 – 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 Estatiga, 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 Estatiga 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 Estatiga, 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 4.4 – 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 (1 tablet) once daily. For patients being re-treated, serum transaminases should be monitored at a minimum of every 2 weeks for 3 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× 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 4-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). 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 Estatiga should be cautiously assessed in patients with moderate hepatic impairment, in whom the benefit clearly should outweigh the possible risk (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Estatiga should not be used in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2 – 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 5.2 – 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 abiraterone acetate in the paediatric population.

Method of administration
Estatiga is for oral use.
The tablets should be taken at least 1 hour before or at least 2 hours after eating. These should be swallowed whole with water.

Contraindications

4.3 Contraindications

• Hypersensitivity to the active substance 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 section 4.6 – 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)].