Important Safety Information

Treatment with SIGNIFOR may lead to decreases in circulating levels of cortisol resulting in biochemical and/or clinical hypocortisolism. SIGNIFOR dose reduction or interruption and/or adding…

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Indication

SIGNIFOR® (pasireotide) Injection 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.

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SIGNIFOR® (pasireotide) Injection, for subcutaneous use

INDICATION

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:

  • Hypocortisolism: Treatment with SIGNIFOR leads to suppression of adrenocorticotropic hormone (ACTH) secretion in Cushing's disease. Suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially hypocortisolism. Monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia or hypoglycemia). SIGNIFOR dose reduction or interruption and/or adding a low-dose, short-term glucocorticoid may be necessary.
  • 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.
  • Bradycardia and QT Prolongation: Bradycardia has been reported with the use of SIGNIFOR. Patients with cardiac disease and/or bradycardia or patients taking drugs associated with bradycardia should be carefully monitored. SIGNIFOR is associated with QT prolongation and should be used with caution in patients who are at significant risk of developing QT prolongation. A baseline ECG is recommended prior to initiating SIGNIFOR and monitoring for an effect on the QTc interval is advisable. Hypokalemia and hypomagnesemia must be corrected prior to SIGNIFOR administration and should be monitored periodically during therapy.
  • Liver Test Elevations: Elevations of ALT or AST >3X ULN were observed in 5% of patients in the Phase III trial. Evaluate liver tests prior to and during treatment with SIGNIFOR. Monitoring of liver tests should be done after 1 to 2 weeks on treatment, then monthly for 3 months, and every 6 months thereafter. If elevated liver test values are confirmed or rising, SIGNIFOR treatment should be interrupted. If resolution of abnormalities to normal or near normal occurs, resuming treatment with SIGNIFOR may be done cautiously, with close observation, and only if some other likely cause has been found.
  • Cholelithiasis: Cholelithiasis has been frequently reported in clinical studies with SIGNIFOR. Ultrasonic examination of the gallbladder before, and at 6- to 12-month intervals during treatment with SIGNIFOR is recommended.
  • Monitoring for Deficiency of Pituitary Hormones: The pharmacological activity of SIGNIFOR mimics that of somatostatin; therefore, inhibition of pituitary hormones other than ACTH may occur. Monitoring of pituitary function prior to initiation of SIGNIFOR and periodically during treatment should be considered. Patients who have undergone transsphenoidal surgery and pituitary irradiation are particularly at increased risk for deficiency of pituitary hormones.

Adverse Reactions:

The most common adverse reactions (frequency ≥20% in either group) occurring in patients receiving SIGNIFOR in clinical trials were:

  • Diarrhea (59%), nausea (58%), hyperglycemia (43%), cholelithiasis (30%), headache (29%), abdominal pain (25%), fatigue (24%), and diabetes mellitus (20%).

Drug Interactions:

  • Caution is required when co-administering SIGNIFOR with drugs that may prolong the QT interval.
  • The following drugs may require monitoring and possible dose adjustments when used with SIGNIFOR: cyclosporine, bromocriptine.

Please see full Prescribing Information.