Signifor Injection

Generic name:pasireotide
Dosage form: injection
Drug class:Somatostatin and somatostatin analogs

Medically reviewed by Drugs.com. Last updated on Jul 1, 2021.

1 INDICATIONS AND USAGE

Cushing's Disease

SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

2 DOSAGE AND ADMINISTRATION

Recommended Dosage Range

The recommended dosage range of SIGNIFOR is 0.3 mg to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability.

Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies(14)]. Maximum UFC reduction is typically seen by two months of treatment [see Clinical Studies (14)]. For patients who are started on 0.6 mg twice a day, a dosage increase to 0.9 mg twice a day may be considered based on the response to the treatment, as long as the 0.6 mg dosage is well tolerated by the patient.

Management of suspected adverse reactions may require temporary dose reduction of SIGNIFOR. Dose reduction by 0.3 mg decrements per injection is suggested.

Recommendations Prior to Initiation of SIGNIFOR

Prior to the start of SIGNIFOR, patients should have baseline levels of the following:

• fasting plasma glucose (FPG) [see Warnings and Precautions (5.2)]
• hemoglobin A1c (HbA1c) <...