Treatment with SIGNIFOR may lead to bradycardia and QT prolongation. Use with caution in at-risk-patients. ECG testing is recommended prior to dosing and during treatment.
ADVERSE REACTIONS (FREQUENCY ≥20%)1
0.6 mg bid
0.9 mg bid
|Diarrhea||48 (59)||46 (58)||94 (58)|
|Nausea||38 (46)||46 (58)||84 (52)|
|Hyperglycemia||31 (38)||34 (43)||65 (40)|
|Cholelithiasis||25 (30)||24 (30)||49 (30)|
|Headache||23 (28)||23 (29)||46 (28)|
|Abdominal pain||19 (23)||20 (25)||39 (24)|
|Fatigue||12 (15)||19 (24)||31 (19)|
|Diabetes mellitus||13 (16)||16 (20)||29 (18)|
See full adverse reactions table in full Prescribing Information.
Signs and symptoms of hyperglycemia include1:
During treatment as recommended:
Hyperglycemia and Diabetes:
Elevations in blood glucose levels have been seen in healthy volunteers and patients receiving SIGNIFOR.
Pre-diabetes and diabetes were observed in the Phase III trial, with nearly all subjects developing worsening glycemia in the first 2 weeks of treatment. Cushing's disease patients with poor glycemic control (as defined by hemoglobin A1c (HbA1c) values >8% while receiving anti-diabetic therapy) may be at a higher risk of developing severe hyperglycemia and associated complications, e.g., ketoacidosis.
Intensive glucose monitoring is recommended and may require initiation or adjustment of anti-diabetic treatment per standard of care. Glycemic status should be assessed prior to starting therapy with SIGNIFOR. Self-monitoring of blood glucose and/or fasting plasma glucose (FPG) assessments should be done every week for the first 2 to 3 months and periodically thereafter, as clinically appropriate, as well as over the first 2 to 4 weeks after any dose increase.
Patients who were initiated on anti-diabetic therapy as a result of SIGNIFOR may require closer monitoring after discontinuation of SIGNIFOR, especially if the anti-diabetic therapy has a risk of causing hypoglycemia.
If uncontrolled hyperglycemia persists, despite appropriate medical management, the dose of SIGNIFOR should be reduced or discontinued.
SIGNIFOR® (pasireotide) Injection, for subcutaneous use
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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
The most common adverse reactions (frequency ≥20% in either group) occurring in patients receiving SIGNIFOR in clinical trials were:
Please see full Prescribing Information.