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.

Patient Resources

Downloadable Content

Patient Brochure

Give your patients more information about SIGNIFOR® LAR (pasireotide) for injectable suspension with this brochure.

View Patient Brochure
View Spanish Patient Brochure

Enrollment Form

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

Support Programs

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:

  1. Patient Education
    By providing up-to-date information for patients and health care professionals on disease education, these programs encourage patients to be proactive in managing their disease
  2. Patient Access
    These programs provide eligible patients access to the medication they need
  3. Patient Treatment
    These programs offer resources and information for both health care providers and patients about their treatment options
 
Patient Education
 

Clinical Trials:

 
Patient Access
 

PEAK Support:

Through PEAK, support is available to help your patients:

  • Access their medication
  • Navigate the insurance process
  • Learn how to successfully manage their injections
  • Find additional organizations and patient groups

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:

  • Insurance verification
  • Coding/billing questions
  • Medicare education
  • Assistance with denials and information on appeals
  • Information about the Novartis Universal Co-Pay Program
  • Referrals to federal or state assistance programs
  • Patient assistance for low-income and uninsured patients
  • Patients pre-qualified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application
 
Patient Treatment
 

Patient Resources:

  • Mixing and Administration for SIGNIFOR® LAR (pasireotide) for injectable suspension:
  • Live in-service mixing and administration demonstrations by Signifor® Clinical Educators for health care professionals to reinforce best practices for patient care. For more information, call 1-800-282-7630.
  • Product Replacement Resource:
  • Novartis Pharmaceuticals Corporation will replace product at no charge if drug administration does not go as planned, helping to ensure peace of mind when administering SIGNIFOR® LAR.
  • Clinical Educators:
  • As part of the Novartis commitment to supporting your practice, Clinical Educators are also available to answer clinical questions and provide tips on how to optimize administration technique. Contact your Signifor® Sales Specialist at 1-800-282-7630 for more information.

Acromegaly Support for Your Patients and You:

Programs specifically for patients taking SIGNIFOR® LAR include:

  • MAP: for eligible patients with acromegaly, providing at-home injection programs
  • RealSupport by PEAK: an information and support program where patients can get helpful answers from experts and stories of real people coping with the symptoms of acromegaly. Patients with acromegaly can enroll here.

Programs to support your practice include:

  • An in-office Mixing and Administration Demonstration

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.

  • 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 at this time

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
  • Convenience for your patient. Your patients can receive injections when it 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
    • This does not replace regular patient visits or monitoring by physicians
  • Nurse handles all needle disposals. The program nurse handles disposal of all equipment

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 the patient's convenience. (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

Patient Support Groups*

The Pituitary Network Association

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

The Neuroendocrine Clinical Center of Massachusetts General Hospital

Harvard Medical School
http://pituitary.mgh.harvard.edu/

National Organization for Rare Disorders (NORD)

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

The Hormone Foundation is the public education affiliate of the Endocrine Society and is a leading source of hormone-related health information.
http://www.hormone.org

*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.

Patient Site

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