SIGNIFOR® LAR (pasireotide) for Injectable Suspension

IMPORTANT SAFETY INFORMATION AND INDICATION

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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…

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Indication

SIGNIFOR^® LAR (pasireotide) for injectable suspension, for intramuscular use 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.

PANO

Novartis Oncology shares your commitment to helping patients receive the medicines prescribed. Patient Assistance Now Oncology (PANO) provides access to information and our wide range of resources available to your patients in over 160 languages.

Support for patients includes:

Insurance benefits verification, including information on denials/appeals
Information about financial assistance that may be available
Patient Support Counselors who are able to provide information in over 160 languages
One dedicated case manager/single point of contact per case

To learn more, call 1-800-282-7630.

Co-Pay Assistance

At Novartis Oncology, we’ve made it easier than ever for patients to access financial support on their prescription costs for almost all Novartis Oncology products.

With the Novartis Oncology Universal Co-Pay Program, eligible, commercially insured patients may pay no more than $25 per month, and Novartis will pay the remaining co-pay, up to $15,000 per calendar year.

Limitations apply. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.

Encourage your patients to find out if they are eligible to enroll in the Universal Co-Pay Program by visiting www.CoPay.NovartisOncology.com or calling 1-877-577-7756.

Mobile Administration Program:

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.

Patients must be recommended by their physician
Residents of all states except Massachusetts, Michigan, Minnesota, and Rhode Island can participate
The program is available to patients covered by most commercial plans (HMO, PPO, etc)
Patients with government-provided medical insurance (eg, Medicare Part B and D, or Medicaid) are not eligible

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.

No guesswork. You know that your patient will receive the right dose, at the right time, using the right technique
Feedback from registered nurses. The nurse will submit a detailed report to you after each visit. You will know when the patient receives his/her treatment at the prescribed dose
Your patients can receive injections at a time and place that is convenient for them. Nurses are available outside traditional office hours, including weekends and evenings, even when patients are traveling within the continental United States
Time saved for your patient. Your patient won't need to make long trips to the treatment center
Nurse handles all needle disposals. The program nurse handles disposal of all equipment

This does not replace regular patient visits or monitoring by physicians

How MAP works

As the prescribing physician, you evaluate your patients on a case-by-case basis and decide who is appropriate for the program
Your office submits the patient's information to the company that administers the program, in one of two ways:

By calling 1-877-503-3377 or
By completing and sending in the enrollment form

Patient eligibility is verified according to your patient's insurance plan
Your patient receives a call to schedule the next injection at a time and place convenient for the patient. (Patients must receive their first dose of SIGNIFOR LAR in your office)
A specially trained treatment nurse visits your patient's home and:

Administers the injection
Schedules the next appointment and follows up with a reminder
Sends a report to you, the prescribing physician, to update you on the patient’s status

Important Things to Note About MAP

The program does not replace your care or the authority of the prescribing physician. It simply provides your patients with the convenience of home injections. Patients still keep their regular, scheduled physician checkups
Patients must receive their first dose of SIGNIFOR LAR in your office
Nurses who take part in this program are specially trained to mix and administer SIGNIFOR LAR

SIGNIFOR^®LAR (pasireotide) for injectable suspension, for intramuscular use

INDICATION

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
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.
QT Prolongation
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:

Adverse reactions associated with SIGNIFOR LAR and occurring in ≥20% of patients were diarrhea, cholelithiasis, hyperglycemia and diabetes mellitus.

Drug Interactions:

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.

Contraindications

None

Please see full Prescribing Information.

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