SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative (1)

• Recommended initial dosage is either 0.6 mg or 0.9 mg by subcutaneous injection twice a day; recommended dosage range is 0.3 mg to 0.9 mg twice a day (2.1) 
• Titrate dosage based on treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) and/or improvements in signs and symptoms of disease] and tolerability (2.1) 
• Testing Prior to Dosing: fasting plasma glucose, hemoglobin A1c, liver tests, electrocardiogram (ECG), gallbladder ultrasound, and serum potassium and magnesium levels (2.2)
• Patients with Hepatic Impairment:
  • Child-Pugh B: Recommended initial dosage is 0.3 mg twice a day and maximum dosage is 0.6 mg twice a day (2.3, 8.6)
  • Child-Pugh C: Avoid use in these patients (2.3, 8.6)

Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose ampule (3)
CONTRAINDICATIONS

None (4)
WARNINGS AND PRECAUTIONS

• Hypocortisolism: Decreases in circulating levels of cortisol may occur resulting in biochemical and/or clinical hypocortisolism. SIGNIFOR dose reduction or interruption and/or adding a low-dose short-term glucocorticoid may be necessary (5.1)
• Hyperglycemia and Diabetes (occurs with initiation): Intensive glucose monitoring is recommended and may require initiation or adjustment of anti-diabetic treatment per standard of care (5.2)
• Bradycardia and QT Prolongation: Use with caution in at-risk patients; ECG testing prior to dosing and on treatment (