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.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
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.
Cholelithiasis: Cholelithiasis was reported in up to 33% of patients treated with SIGNIFOR LAR in clinical trials. Patients should be monitored periodically.
Pituitary Hormone Deficiency(ies): Suppression of pituitary hormones other than GH/IGF-1, may occur on SIGNIFOR LAR. Monitoring pituitary function (e.g., thyroid, adrenal, gonadal) prior to initiation of therapy with SIGNIFOR LAR, as well as periodically during treatment, as clinically appropriate, is recommended. Patients should be monitored for and instructed on the signs and symptoms of adrenal insufficiency during therapy. If adrenal insufficiency is suspected it should be confirmed and treated per standard of care with exogenous glucocorticoids at replacement doses.
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.