Indications and Usage
SIGNIFOR LAR (pasireotide) is a somatostatin analog indicated for the treatment of:
- Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
- Patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Important Safety Information
Warnings and Precautions
- Hyperglycemia, Diabetes, and Ketoacidosis: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Monitor glucose levels as clinically appropriate during therapy. There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with history of diabetes and in patients without history of diabetes. Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic treatment or adjustment in their current anti-diabetic treatment. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, reduce the dose or discontinue SIGNIFOR LAR. If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient. Please see sections 2.1, 5.1 in full Prescribing Information.
- Bradycardia and QT Prolongation: Bradycardia has been reported with the use of SIGNIFOR LAR (pasireotide). Patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia, high grade heart block, or concomitant use of drugs associated with bradycardia, should be monitored. Adjustments in the dose of drugs known to slow the heart rate (e.g., beta-blockers, calcium channel blockers) and correction of electrolyte disturbances may be necessary when initiating or during the course of SIGNIFOR LAR (pasireotide) treatment. Use with caution in at-risk patients; evaluate ECG and electrolytes prior to dosing and periodically while on treatment.
- Liver Test Elevations: Evaluate liver enzyme tests prior to and during treatment. Please see sections 2.1, 5.3 in full Prescribing Information.
- Cholelithiasis and Complications of Cholelithiasis: Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Please see section 5.4 in full Prescribing Information.
- Pituitary Hormone Deficiency(ies): Monitor for occurrence periodically and treat if clinically indicated. Please see section 5.5 in full Prescribing Information.
- Adverse drug reactions associated with SIGNIFOR LAR (pasireotide) and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia and diabetes mellitus.
- To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575- 8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Drugs that Prolong QT: Use with caution in patients who are at significant risk of developing QTc prolongation.
- Cyclosporine: Consider additional monitoring.
- Bromocriptine: Consider bromocriptine dose reduction.
Females and Males of Reproductive Potential
- Advise premenopausal females of the potential for an unintended pregnancy.
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