Signifor (pasireotide) is indicated for adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.
Signifor (pasireotide) intramuscular injection is indicated for adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue (SSA).
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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Important safety information about Signifor (pasireotide)
Signifor is contraindicated in patients with severe hepatic impairment (Child Pugh C).
Hyperglycemia and diabetes occurs with initiation of Signifor therapy. Acromegaly 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.
Treatment with Signifor may lead to bradycardia and QT prolongation. Caution should be used in at-risk patients. ECG testing is recommended prior to dosing and during treatment. Hypokalemia and hypomagnesemia must be corrected prior to Signifor administration and should be monitored periodically during therapy.
Mild transient elevations in aminotransferases are commonly observed in patients treated with pasireotide. Liver tests are recommended prior to and after the first 2 to 3 weeks on treatment, then monthly for 3 months, and as clinically indicated thereafter.
Cholelithiasis is associated with Signifor. Gallbladder ultrasounds should be performed before and at 6- to 12- month intervals.
Inhibition of pituitary hormones may occur with Signifor treatment. Monitoring of pituitary function should occur prior to initiation of therapy and periodically during treatment with Signifor.
Treatment with Signifor may lead to a decrease in circulating levels of cortisol resulting in biochemical and/or clinical hypocortisolism. Signifor dose of reduction or interruption and/or adding low-dose short-term glucocorticoid therapy may be necessary.
Caution is required when co-administering Signifor with anti-arrhythmics and drugs that prolong QT. The following drugs may require monitoring and possible dose adjustments when used with Signifor: cyclosporine, bromocriptine.
The most common adverse reactions (≥10%) occurring in patients in acromegaly clinical trials are hyperglycemia, diabetes mellitus, diarrhea, abdominal pain, cholelithiasis and alopecia.