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…
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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 (MAP) was created 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. This program is not intended to replace the care provided by a patient's health care team.
Which patients are eligible?
The MAP is available to 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
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.
SIGNIFOR LAR is a somatostatin analog indicated for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
A majority of patients, including those with normal glucose tolerance, prediabetes, and diabetes, experienced increased glucose levels within the first 2 to 3 months of treatment with SIGNIFOR LAR.
In the acromegaly study, 5 patients exposed to SIGNIFOR LAR were hospitalized with blood glucose levels in the range of 359 mg/dL to 506 mg/dL. Two additional patients with acromegaly who were switched to SIGNIFOR LAR from active comparator were hospitalized for elevated glucose and one of those patients developed diabetic ketoacidosis. In the Cushing’s disease study, 2 patients were hospitalized for elevated glucose.
Fasting plasma glucose and hemoglobin A1c should be assessed prior to starting treatment with SIGNIFOR LAR. In patients with poorly controlled diabetes mellitus, antidiabetic 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 antidiabetic therapy(ies) or adjustment in the dose or type of antidiabetic therapy(ies) per standard of care. The optimal treatment for the management of hyperglycemia associated with SIGNIFOR LAR 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 antidiabetic therapy discontinuing SIGNIFOR LAR may require more frequent blood glucose monitoring and antidiabetic dose adjustment to mitigate the risk of hypoglycemia.
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 (eg, 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 electrocardiogram 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.
In the phase 3 Cushing’s disease study and across all doses, ALT or AST elevations greater than 3 times the ULN were observed in 14% of the patients with Cushing’s disease and ALT or AST elevations greater than 5 times the ULN were observed in 5% of patients with Cushing’s disease treated with SIGNIFOR LAR.
Assessment of liver function is recommended prior to treatment with SIGNIFOR LAR, 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 pretreatment levels. Treatment with SIGNIFOR LAR should be discontinued if signs or symptoms suggestive of clinically significant liver impairment develop.
Adverse reactions in patients with acromegaly associated with SIGNIFOR LAR and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia, and diabetes mellitus.
Adverse reactions in patients with Cushing’s disease associated with SIGNIFOR LAR and occurring in ≥20% of patients were hyperglycemia, diarrhea, cholelithiasis, diabetes mellitus, abdominal pain, nausea, and fatigue.
Caution is advised when coadministering 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.