Zytiga

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

abiraterone (abiraterone acetate)

Available from:

Janssen-Cilag S.p.A.

INN (International Name):

abiraterone (abiraterone acetate)

Dosage:

250mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ZYTIGA 250 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed
with AA250 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZYTIGA 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 5.1)

the treatment of metastatic castration resistant prostate cancer in
adult men whose disease has
progressed on or after a docetaxel-based chemotherapy regimen.
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 (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 4.5 and 5.2).
ZYTIGA 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
thereaft