ZYTIGA®▼ 250mg Tablets PRESCRIBING INFORMATION
Please refer to Summary of Product Characteristics (SmPC) before prescribing.
Taken 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.
DOSAGE & ADMINISTRATION: Adults:
1000 mg (4 tablets) single daily dose. Not with food
as this increases the
systemic exposure (take dose at least two hours after eating; no food for at least one
hour post-dose). Swallow whole with water. Take with recommended dose of prednisone
or prednisolone of 10 mg daily.
No relevant use. Renal impairment:
No dose adjustment, however no experience in patients with prostate
cancer and severe renal impairment; caution advised.
If hepatotoxicity develops (ALT >5x upper limit of normal - ULN), stop
treatment immediately until liver function returns to baseline; restart Zytiga at 500 mg (2
tablets) once daily and monitor serum transaminases at least every 2 weeks for 3 months
and monthly thereafter (see Special warnings & precautions). If hepatotoxicity recurs on
reduced dose, stop treatment. If severe hepatotoxicity develops (ALT 20xULN), discontinue
Zytiga and do not restart.
Mild (Child-Pugh class A) - no dose adjustment. Moderate (Child-
Pugh class B) - approximately 4x increased systemic exposure after single oral doses of
1,000 mg. Moderate/Severe (Child-Pugh class B or C) – no clinical data for multiple doses;
Pregnancy or potential to be pregnant. Hypersensitivity to active substance or any
SPECIAL WARNINGS & PRECAUTIONS: Cardiovascular:
Caution in patients with history of cardiovascular disease. Safety not
established in patients with left ventricular ejection fraction < 50% or NYHA Class III or IV
heart failure. Control hypertension and correct hypokalaemia pre-treatment. Caution in
patients whose medical conditions might be compromised by hypertension, hypokalaemia or
fluid retention e.g. heart failure, severe or unstable angina pectoris, recent myocardial
infarction or ventricular arrhythmia, severe renal impairment. Monitor blood pressure, serum
potassium and fluid retention before treatment and at least monthly thereafter. Hepatotoxicity:
Measure serum transaminases pre-treatment and every two weeks for first
three months, then monthly. If symptoms/signs suggest hepatotoxicity, immediately measure
serum transaminases, particularly serum ALT. If ALT > 5x ULN, stop treatment and monitor
liver function. Restart treatment after liver function returns to baseline; use reduced dose
(see above). No clinical data in patients with active or symptomatic viral hepatitis. Corticosteroid withdrawal:
Monitor for adrenocortical insufficiency if prednisone or
prednisolone is withdrawn. Monitor for mineralocorticoid excess if Zytiga continued after
corticosteroids withdrawn. Bone density:
Decreased bone density may be accentuated by
ZYTIGA plus glucocorticoid. Prior use of ketoconazole:
Lower response rates may occur in
patients previously treated with ketoconazole for prostate cancer. Intolerance to excipients:
Not to be taken by patients with galactose intolerance, Lapp lactase deficiency or glucose-
galactose malabsorption. Take sodium content into account for those on controlled sodium
diet. SIDE EFFECTS: Very common:
urinary tract infection, hypokalaemia, hypertension, peripheral oedema Common:
hypertriglyceridaemia, cardiac failure (including congestive heart failure, left
ventricular dysfunction and decreased ejection fraction), angina pectoris, arrhythmia, atrial
fibrillation, tachycardia, increased alanine aminotransferase. Uncommon:
insufficiency. Refer to SmPC for other side effects.
FERTILITY/ PREGNANCY/ LACTATION:
Not for use in women. Not known whether
abiraterone or its metabolites are present in semen. A condom is required if the patient is
engaged in sexual activity with a pregnant woman. If the patient is engaged in sex with a
woman of childbearing potential, a condom is require along with another effective
contraceptive method. No fertility data available. It is not known if either abiraterone acetate
or its metabolites are excreted in human milk.
Caution with drugs activated by or metabolised by CYP2D6 particularly when there is a
narrow therapeutic index eg metoprolol, propranolol, desipramine, venlafaxine,
haloperidol, risperidone, propafenone, flecanide, codeine, oxycodone and tramadol.
Zytiga is CYP3A4 substrate (in vitro
data); avoid or use with caution with strong CYP3A4
inhibitors (eg ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone,
saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (eg
phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital). Food (see
above). LEGAL CATEGORY:
POM PRESENTATIONS, PACK SIZES, PRODUCT LICENCE NUMBERS & BASIC NHS
EU/1/11/714/001; 120 tablets: £2930. MARKETING AUTHORISATION HOLDER:
JANSSEN-CILAG INTERNATIONAL NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
FURTHER INFORMATION IS AVAILABLE FROM:
Janssen-Cilag Ltd, 50-100 Holmers
Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Janssen-Cilag Ltd 2011
Prescribing information last revised: October 2011
PIVER1011 Adverse events should be reported. Reporting forms and information can be found at
www.yellowcard.gov.uk Adverse events should also be reported to Janssen-Cilag Ltd.
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BUNDESVERWALTUNGSGERICHT IM NAMEN DES VOLKES hat der 5. Senat des Bundesverwaltungsgerichts auf die mündliche Verhandlung vom 8. November 2012 durch den Vorsitzenden Richter am Bundesverwaltungsgericht Vormeier, die Richterin am Bundesverwaltungsgericht Stengelhofen und die Richter am Bundesverwaltungsgericht Dr. Störmer, Dr. Häußler und Dr. Fleuß für Recht erkannt: Die Revision de