Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
---------------------------------------------------------------
1. NAME OF THE MEDICINAL PRODUCT
ZYTIGA 250 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate.
Excipients
Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White to off-white oval tablets, 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 whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
4.2 Posology and method of administration
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 information on the method of administration). 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.
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 (see section 4.4).
In the event of a missed daily dose of either ZYTIGA, 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 above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section 4.4). 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 20 times the upper limit of normal) 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-exi |
