SUPPORT & RESOURCES

IPSEN CARES® (Coverage, Access, Reimbursement & Education Support) serves as a central point of contact between patients, caregivers, doctors’ offices, insurance companies, and specialty pharmacies.

Help patients navigate the insurance coverage process to determine out-of-pocket costs for treatment

Help with copay assistance for eligible* patients

Provide information on Nurse Home Health Administration

 

Provide free medication to eligible patients through the Patient Assistance Program

Help minimize delays or interruptions to treatment

Coordinate medication deliveries through specialty pharmacies

 

Learn more at IPSENCARES.com

Go to Somatuline Depot Page ipsencares.com

 

A comprehensive service and support program to help eligible patients get access to medications and services, and help physician offices, too.

The IPSEN CARES® program was designed to simplify the process of applying for and getting coverage for Somatuline Depot. By serving as a central point of contact between you, your patients, insurance companies, and specialty pharmacies, IPSEN CARES can save your office valuable time and energy. The IPSEN CARES program provides online and PDF forms to help your staff get patients efficiently enrolled and authorized; provides information on copay programs and other financial assistance; and helps coordinate home delivery and home injection services.

 

Go to Somatuline Depot page IPSENCARES.com

Or call 1-866-435-5677, Monday-Friday, 8am-8pm ET (5am-5pm PT)
 

HCP Resource Guide

The Somatuline® Depot Resource Guide contains important information to help you with purchasing, billing, coding and reimbursement, plus more details and FAQs for IPSEN CARES.

Download

Community organizations that provide acromegaly patients with information and support

National Endocrine and Metabolic Diseases Information Service

A service of the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH)

https://www.niddk.nih.gov/health-information/endocrine-diseases/acromegaly

Pituitary Network Association

Learn more about pituitary disorders, get contact information about hormonal health hospitals near you, and get answers to frequently asked questions.

http://www.pituitary.org

IMPORTANT SAFETY INFORMATION & INDICATION

Contraindications

  • SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

Warnings and Precautions

  • Cholelithiasis and Gallbladder Sludge
    • SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
    • Periodic monitoring may be needed.
    • If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.
  • Hypoglycemia or Hyperglycemia
    • Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
    • Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
  • Cardiovascular Abnormalities
    • SOMATULINE DEPOT may decrease heart rate.
    • In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
    • In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia.
    • In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
  • Thyroid Function Abnormalities
    • Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
    • Thyroid function tests are recommended where clinically appropriate.
  • Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.

Most Common Adverse Reactions 

  • Adverse reactions in >5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), vomiting (7%), arthralgia (7%), headache (7%), and loose stools (6%).

Drug Interactions

  • SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

  • Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
  • Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATIONS

SOMATULINE® DEPOT (lanreotide) is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.

Please click here for the full Prescribing Information and Patient Information.

 

References:

1. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; April 2019.

2. Melmed S, Cook D, Schopohl J, Goth MI, Lam KSL, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13:18-28.

3. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.

4. Valery C, Paternostre M, Robert B, et al. Biomimetic organization: octapeptide self-assembly into nanotubes of viral capsid-like dimension. PNAS. 2003;100(18):10258-10262.

5. Melmed S. Medical progress: Acromegaly. N Engl J Med. 2006 Dec 14;355(24):2558-73. Review. No abstract available. Erratum in: N Engl J Med. 2007 Feb 22;356(8):879.

6. Burton T, Le Nestour E, Neary M, Ludlam WH. Incidence and prevalence of acromegaly in a large US health plan database. Pituitary. 2016;19:262-267.

7. Katznelson L, Atkinson JL, Cook DM, Ezzat SZ, Hamrahian AH, Miller KK; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly–2011 update. Endocr Pract. 2011 Jul-Aug;17 Suppl 4:1-44.

8. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.

9. Melmed S, Bronstein MD, Chanson P, Klibanski A, Casanueva FF, Wass JAH, Strasburger CJ, Luger A, Clemmons DR, Giustina A. A Consensus Statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018 Sep;14(9):552-561.

10. Jane JA Jr, Starke RM, Elzoghby MA, Reames DL, Payne SC, Thorner MO, Marshall JC, Laws ER Jr, Vance ML. Endoscopic transsphenoidal surgery for acromegaly: remission using modern criteria, complications, and predictors of outcome. J Clin Endocrinol Metab. 2011 Sep;96(9):2732-40.

11. Starke RM, Raper DM, Payne SC, Vance ML, Oldfield EH, Jane JA Jr. Endoscopic vs microsurgical transsphenoidal surgery for acromegaly: outcomes in a concurrent series of patients using modern criteria for remission. J Clin Endocrinol Metab. 2013 Aug;98(8):3190-8.

©2019 Ipsen Biopharmaceuticals, Inc. All rights reserved. March 2019 SMD-US-002663

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