This is an international Web site for Signifor® (pasireotide) and is intended for healthcare professionals outside the US. The information on the site is not country specific, and may contain information that is outside the approved indications in the country in which you are located. Please contact your local Novartis representative for the latest information specific to your country.

Signifor Information for International Healthcare Professionals Signifor Information for US residents Signifor Information for Patients Outside the US

Summary of Product Characteristics Patient Leaflet Safety Information AAA | Print | Share

U.S. RESIDENTS | This site is intended for healthcare professionals outside the US.

English Español

MOA|Trial Design|Efficacy|Safety|Dosing and Adminstration

Hyperglycaemia

HOME ABOUT SIGNIFOR Safety

Signifor Safety Profile

Signifor demonstrated a tolerability profile that was similar to that of other somatostatin analogues, with the exception of the degree of hyperglycaemia.1

Special warnings and precautions for use2

Adverse reactions Observed during clinical trials Monitor
Glucose metabolism disorders Alterations in blood glucose levels have been frequently reported with Signifor. Glycaemic status should be assessed prior to starting treatment with Signifor and during treatment. Monitoring should follow established guidelines.
Liver enzymes Healthy volunteers and patients treated with Signifor commonly exhibit mild transient increases in aminotransferases. Monitoring of liver function is recommended prior to beginning Signifor treatment and after 1, 2, 4, 8, and 12 weeks of treatment.
Rare cases of concurrent elevations in ALT >3 x ULN and bilirubin >2 x ULN have also been observed.
Cardiovascular-related events Bradycardia has been reported in patients treated with Signifor. Careful monitoring of cardiac function is recommended in patients with cardiac disease and/or risk factors for bradycardia.
Signifor has been shown to prolong the QT interval on the ECG in 2 dedicated healthy volunteer studies. Monitoring for an effect of Signifor on the QTc interval is recommended, and an ECG should be performed before beginning treatment with Signifor.
Hypocortisolism Treatment with Signifor leads to rapid suppression of ACTH secretion in Cushing's disease patients. It is necessary to monitor and instruct patients on the signs and symptoms associated with hyposcortisolism.
   

ALT=alanine aminotransferase; ECG=electrocardiogram.

HYPERGLYCAEMIA AND SIGNIFOR
References: 1. Colao A, Petersenn S, Newell-Price J, et al. A 12-month, phase 3 study of pasireotide in Cushing's disease. N Engl J Med. 2012;366:914-924. 2. Signifor Summary of Product Characteristics. Novartis Pharma AG.

Frequently asked questions

Find answers to common questions about Cushing's disease and treatment with Signifor.

Click here
Disclaimer: This is an international Web site for Signifor® (pasireotide) and is intended for healthcare professionals outside the US. If you are a US resident, please click on the US Residents link at the top of this page. The information on this site is not country specific and may contain information that is outside the approved indications in the country in which you are located.
Novartis Oncology

About Novartis Oncology Contact Us Site Map Use of Web site is governed by the Terms of Use and Privacy Policy
© Novartis AG