Getting a patient started on SIGNIFOR LAR

RESOURCES AND SUPPORT FOR A SUCCESSFUL START

Recordati Rare Diseases ensures your patients receive dedicated, multi-point services and support every step of the way through the treatment journey. Complete the Patient Prescription Form to get your patients started.


R.A.R.E.® Patient Support

A collaboration of support and services, the R.A.R.E. Patient Support Program is a one-stop source for starting a new patient, and provides access to a full range of Recordati Rare Diseases tools and resources.

access and financial assistance

Our reimbursement team
will help:

  • Provide support for any Prior Authorization and Appeal requirement
  • Investigate patient insurance benefits 
  • Administrate co-pay assistance for eligible insured patients and help patients identify other financial assistance opportunities

dispensing and delivering

Our trained pharmacy team
will help:

  • Patients receive treatment on time with overnight delivery 
  • Educate about treatment and answer patients’ questions before the first prescription is dispensed 
  • Provide 24/7 pharmacy support

EDUCATION and adherencea

Our clinical nurse educator will
make regular calls to:

  • Assess adherence, answer questions, and assess patients’ therapy satisfaction 
  • Alert you if they become aware of any issues that require your attention
Recordati Rare Diseases offers a $20 co-pay for qualified patients with commercial insurance.b
a
Information provided by the clinical nurse educator is for educational purposes only and is not intended to replace the advice of the healthcare provider.
b
Eligibility requirements, restrictions, and limitations apply.

Mobile Injection Program

When patients are prescribed SIGNIFOR LAR, they are eligible for enrollment in the
Mobile Injection Program through the R.A.R.E. Patient Support Program. This exclusive program is designed to make the patient treatment journey more convenient by providing in-home medication administration directly by a registered nurse.

This service is provided at no cost to you, your patient, or their insurance provider.

You can be confident knowing your patients will stay on track with their treatment plan.

Enrolling a patient is easy. When completing the Patient Prescription Form, under the ‘Nursing’ section at the bottom of the form, check ‘Yes’ for patient home administration preference.


Get a patient started on SIGNIFOR LAR

STEP 1:

FILL OUT A PATIENT PRESCRIPTION FORM

  • Download the Patient Prescription Form

  • Download the Patient Prescription Form

STEP 2:

SUBMIT THE FORM

  • Fax fully completed Patient Prescription Form to Anovo Specialty Rx at: 1-85‍5-813‍-2039

  • NCPDP #: 4445640

OR

  • Electronically submit fully completed Patient Prescription Form to Anovo Specialty Rx in your EMR system. When ordering, choose: Anovo#5

  • NCPDP #: 4445640

  • Fax fully completed Patient Prescription Form to Anovo Specialty Rx at: 1-85‍5-813‍-2039

  • NCPDP #: 4445640

OR

  • Electronically submit fully completed Patient Prescription Form to Anovo Specialty Rx in your EMR system. When ordering, choose: Anovo#5

  • NCPDP #: 4445640

Contact the R.A.R.E. Patient Support Program for assistance:

Monday-Friday between
8:00 AM and 8:00 PM ET

Phone: 1-888-855-RARE (7273)
Fax: 1-855-813-2039

A clinical pharmacist is always available.

R.A.R.E Resources is a one-stop destination that provides what you need to initiate SIGNIFOR LAR treatment, plus gives you access to a full range of Recordati Rare Diseases tools and resources.

Office & Patient Resources

HCP RESOURCES:

To prescribe your patients SIGNIFOR LAR, complete this form.

Information about getting a patient started on SIGNIFOR LAR, including dosing, titration, patient support, and more.

Information about dedicated, multi-point services and support for your SIGNIFOR LAR patients.

Watch instructions for preparation and administration of SIGNIFOR LAR.

INSURANCE RESOURCES:

Editable example letter to support communication with patients’ insurance providers. Download template directly to your computer/device.

Editable example letter to support communication with patients’ insurance providers. Download template directly to your computer/device.

PATIENT RESOURCES:

INDICATIONS AND USAGE

SIGNIFOR LAR® (pasireotide) 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

Hyperglycemia, Diabetes, and Ketoacidosis: SIGNIFOR LAR can cause increases in blood glucose levels which are sometimes severe. Monitor glucose levels as clinically appropriate during therapy. There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with or without history of diabetes. Patients with poor baseline glycemic control are at higher risk of developing severe hyperglycemia. Patients who develop significant hyperglycemia on SIGNIFOR LAR may require initiation of anti-diabetic treatment or adjustment in their current anti-diabetic treatment. The optimal treatment for the management of SIGNIFOR LAR-induced hyperglycemia is not known. If hyperglycemia cannot be controlled despite medical management, reduce the dose or discontinue SIGNIFOR LAR. Patients who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of diabetes history. If ketoacidosis is suspected, discontinue SIGNIFOR LAR and promptly evaluate and treat the patient.

Bradycardia and QT Prolongation: Bradycardia has been reported with the use of SIGNIFOR LAR. Patients with cardiac disease and/or risk factors 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. In cardiac electrophysiology studies with pasireotide via subcutaneous route, QT prolongation occurred at therapeutic and supra-therapeutic doses. Use with caution in patients at significant risk; evaluate ECG and electrolytes prior to dosing 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. Evaluate liver enzyme tests prior to and during treatment.

Cholelithiasis and Complications of Cholelithiasis: There have been reports of cholelithiasis resulting in complications including cholecystitis or cholangitis and requiring cholecystectomy in patients taking SIGNIFOR LAR. Monitor periodically. Discontinue SIGNIFOR LAR if complications of cholelithiasis are suspected and treat appropriately.

Pituitary Hormone Deficiency(ies): Suppression of anterior pituitary hormones may occur on SIGNIFOR LAR. Monitor for occurrence periodically and treat if clinically indicated.

Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency.

The most common adverse reactions occurring in ≥ 20% of patients with acromegaly were diarrhea, hyperglycemia, cholelithiasis, and diabetes mellitus.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

  • Drugs that Prolong QT: Co-administration of drugs that prolong the QT interval with SIGNIFOR LAR may have additive effects on the prolongation of the QT interval. Monitoring effects on the QT interval at 21 days is recommended.
  • Cyclosporine: Concomitant administration of cyclosporine with SIGNIFOR LAR may decrease the relative bioavailability of cyclosporine and, therefore, dose adjustment of cyclosporine to maintain therapeutic levels may be necessary.
  • Bromocriptine: Co-administration of SIGNIFOR LAR with bromocriptine may increase the blood levels of bromocriptine. Dose reduction of bromocriptine may be necessary.

Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy.

SIGNIFOR LAR® (pasireotide) for injectable suspension, for intramuscular use, is available as 10 mg, 20 mg, 30 mg, 40 mg, and 60 mg powder in a vial to be reconstituted with the provided 2 mL diluent.

Please see full Prescribing Information and Patient Information.