Warnings and Precautions: Hyperglycemia and Diabetes: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Patients with poor baseline glycemic control are at…+
Give your patients more information about SIGNIFOR® LAR (pasireotide) for injectable suspension with this brochure.View Patient Brochure
Use the Enrollment Form to sign your patients up for PEAK, so that they can access SIGNIFOR LAR after your prescription is written.View Enrollment Form
Novartis Pharmaceuticals Corporation is committed to supporting your patients who are considering or have been prescribed SIGNIFOR® LAR (pasireotide) for injectable suspension. As part of that commitment, there are a variety of resources and information to help both health care providers and patients. These resources are aimed at helping you to provide the best care for your patients.
Three key areas to help you optimize patient care:
Through PEAK, support is available to help your patients:
PEAK aims to make it easier for your patients to find the support they need.
HOW TO CONTACT PEAK
By phone: 1-877-503-3377
Visit our website at: www.PEAKHelp.com
Support for Patients Includes:
Acromegaly Support for Your Patients and You:
Programs specifically for patients taking SIGNIFOR® LAR include:
Programs to support your practice include:
Mobile Administration Program (MAP):
Our Nurses Are Here for Your Patients
When caring for patients who are receiving SIGNIFOR® LAR therapy, you know how important it is to administer injections exactly as prescribed. But you also know that it's not always easy for some of your patients to get to the office to receive their injections by a trained health care provider.
The Signifor Mobile Administration Program was created not to replace each and every office visit, but to help eligible patients receive their injections on schedule at home or at a location convenient to them, by a trained health care professional. Through this program, you will receive regular patient reports, to keep you up to date on your patients' receipt of SIGNIFOR® LAR injections.
Which Patients Are Eligible?
The MAP is an additional benefit for all appropriate and eligible patients with acromegaly for whom SIGNIFOR® LAR has been prescribed.
Your office can confirm patient eligibility easily by calling 1-877-503-3377 and speaking with a representative. You can also print the enrollment form by clicking here.
Advantages of the MAP
Because the program provides specially trained registered nurses, you can feel confident that your eligible patients will be taken care of professionally and that the highest standards will be adhered to.
How MAP Works
Important Things to Note About MAP
The Pituitary Network Association (PNA) is an international non-profit organization for patients with pituitary tumors and disorders, their families, loved ones, and the physicians and health care providers who treat them.
http://www.pituitary.org or call 1-805-499-9973
Harvard Medical School
NORD includes acromegaly in its rare-disease database and will e-mail or fax you a full report for a nominal fee.
http://www.rarediseases.org/ or call 1-800-999-NORD
The Hormone Foundation is the public education affiliate of the Endocrine Society and is a leading source of hormone-related health information.
*Novartis Pharmaceuticals Corporation may make donations to these support groups and organizations. However, Novartis Pharmaceuticals Corporation has no control over third-party websites and makes no representation as to the accuracy, completeness, adequacy, or any other aspects of the information contained on such websites.
SIGNIFOR® LAR (pasireotide) for injectable suspension, for intramuscular use
SIGNIFOR LAR 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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
Hyperglycemia and Diabetes: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia.
A majority of patients, including those with normal glucose tolerance, pre-diabetes and diabetes, experienced increased glucose levels within the first 2 to 3 months of treatment with SIGNIFOR LAR.
Fasting plasma glucose and hemoglobin A1c should be assessed prior to starting treatment with SIGNIFOR LAR. In patients with poorly controlled diabetes mellitus, anti-diabetic treatment should be optimized before SIGNIFOR LAR treatment is started. Blood glucose monitoring should be done weekly for the first 3 months after initiating SIGNIFOR LAR and the first 4 to 6 weeks after dose increases. Periodic monitoring should continue thereafter, as clinically appropriate.
Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic therapy(ies) or adjustment in the dose or type of anti-diabetic therapy(ies) per standard of care. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled, despite medical management, the dose of SIGNIFOR LAR should be reduced or discontinued.
After treatment discontinuation, fasting plasma glucose and hemoglobin A1c should be assessed if indicated. Patients on anti-diabetic therapy discontinuing SIGNIFOR LAR may require more frequent blood glucose monitoring and anti-diabetic dose adjustment to mitigate the risk of hypoglycemia.
Bradycardia and QT Prolongation
Bradycardia has been reported with the use of SIGNIFOR LAR. Patients with cardiac disease and/or risk factor 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 treatment.
SIGNIFOR LAR is associated with QT prolongation and should be used with caution in patients who are at significant risk of developing prolongation of the QT interval. A baseline ECG is recommended prior to initiating therapy with SIGNIFOR LAR and periodically while on treatment. Hypokalemia or hypomagnesemia must be corrected prior to initiating SIGNIFOR LAR and should be monitored periodically during therapy.
Liver Test Elevations
Increases in liver enzymes have been observed with SIGNIFOR LAR. ALT or AST elevation greater than 3 times the upper limit of normal (ULN) were observed in 3% of patients and ALT or AST elevation greater than 5 times the upper limit of normal (ULN) were observed in 1% of patients treated with SIGNIFOR LAR.
Assessment of liver function is recommended prior to treatment with SIGNIFOR LAR, and after the first 2 to 3 weeks, then monthly for 3 months. Thereafter, liver function should be monitored as clinically indicated. Patients who develop increased transaminase levels should be monitored until values return to pre-treatment levels. Treatment with SIGNIFOR LAR should be discontinued if signs or symptoms suggestive of clinically significant liver impairment develop.
Adverse reactions associated with SIGNIFOR LAR and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia and diabetes mellitus.
Caution is advised when co-administering drugs that prolong the QT interval with SIGNIFOR LAR
The following drugs may require monitoring and possible dose adjustment when used with SIGNIFOR LAR: cyclosporine and bromocriptine
Please see full Prescribing Information