ADT = androgen-deprivation therapy.
IMPORTANT SAFETY INFORMATION
Contraindications—ZYTIGA® is not indicated for use in women.
ZYTIGA® can cause fetal harm (Pregnancy Category X) when
administered to a pregnant woman and is contraindicated in
women who are or may become pregnant.
Hypertension, Hypokalemia, and Fluid Retention Due to
Mineralocorticoid Excess—Use with caution in patients with
a history of cardiovascular disease or with medical conditions
that might be compromised by increases in blood pressure,
hypokalemia, or fluid retention. ZYTIGA® may cause hypertension,
hypokalemia, and fluid retention as a consequence of increased
mineralocorticoid levels resulting from CYP17 inhibition. Safety
has not been established in patients with LVEF < 50% or New
York Heart Association (NYHA) Class III or IV heart failure (in
study 1) or NYHA Class II to IV heart failure (in study 2) because
these patients were excluded from these randomized clinical
trials. Control hypertension and correct hypokalemia before and
during treatment. Monitor blood pressure, serum potassium, and
symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI)—AI was reported in patients
receiving ZYTIGA® in combination with prednisone, after an
interruption of daily steroids and/or with concurrent infection
or stress. Use caution and monitor for symptoms and signs of
AI if prednisone is stopped or withdrawn, if prednisone dose is
reduced, or if the patient experiences unusual stress. Symptoms
and signs of AI may be masked by adverse reactions associated
with mineralocorticoid excess seen in patients treated with
ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI.
Increased dosages of corticosteroids may be used before, during,
and after stressful situations.