Prostaxen 60

• Metastatic castration-sensitive prostate cancer (mCSPC)
• Non-metastatic castration-resistant prostate cancer (NM-CRPC)

Recommended Dose: 240 mg (four 60 mg tablets) orally once daily.

Concurrent Treatment: Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy.

Important: Swallow tablets whole. Do not crush or split the tablets.

Common (>10%):

• Hypercholesterolemia (76%)
• Anemia (70%)
• Hyperglycemia (70%)
• Hypertriglyceridemia (67%)
• Leukopenia (47%)
• Lymphopenia (41%)
• Fatigue (39%)
• Hyperkalemia (32%)
• Hypertension (25%)
• Rash (24%)
• Diarrhea (20%)
• Nausea (18%)
• Arthralgia (16%)
• Fall (16%)
• Weight decreased (16%)
• Hot flush (14%)
• Fracture (12%)
• Decreased appetite (12%)
• Peripheral edema (11%)

Grades 3-4 (>10%): Hypertension (14%)

1-10%: Hypothyroidism (8%), Pruritus (6.2%), Ischemic heart disease (3.7%), Heart failure (2.2%)

Grades 3-4 (1-10%): Rash (5%), Fracture (3%), Fall (2%), Hypertriglyceridemia (2%), Lymphopenia (2%), Hyperkalemia (2%), Hyperglycemia (2%)

Serious Precautions:

• Not recommended in patients with history of seizures or predisposing factors (brain injury, stroke, brain tumors) - permanently discontinue if seizure occurs during treatment
• Falls and fractures risk - evaluate patient for risk; consider bone-targeted agents
• Ischemic heart disease - most patients had cardiac risk factors; monitor for signs and symptoms
• Safety not established in patients with clinically significant cardiovascular disease in the past 6 months
• Androgen deprivation therapy may prolong QT interval
• Contraindicated during pregnancy - may cause fetal harm
• Not indicated for use in females