For the long-term treatment of patients with acromegaly who had inadequate response to or cannot be treated with surgery and/or radiotherapy

SOMATULINE DEPOT: MAINTAINED EFFICACY IN REDUCING GH AND NORMALIZING IGF-1


The 1-year pivotal trial

EFFICACY IN THE 1-YEAR PIVOTAL TRIAL1

Primary endpoint at Week 4

  • 63% of Somatuline® Depot (lanreotide) Injection patients (52/83) achieved >50% decrease of growth hormones vs 0% of placebo patients (0/25) (P<0.001)

Efficacy achieved in the first 16 weeks was maintained through 52 weeks*1,2

Patients experienced a >50% decrease in GH across all doses

  • 82% of patients experienced >50% reduction in GH at Week 52 (81/99)*

Study design: In a 1-year study including a 4-week, double-blind, placebo-controlled phase (N=107); After Week 4, all patients received active drug and entered a 16-week, single-blind, fixed-dose phase (N=105) and a 32-week, open-label, dose-titration phase (N=99) injections of 60, 90, or 120 mg were given at 4-week intervals. During the dose-titration phase of the study, the dose was titrated twice, if needed, according to individual GH and IGF-1 levels.

  • *Week 16 and Week 52 data were secondary endpoints in the pivotal trial.2
  • P value is vs placebo.
  • Week 4 data were a primary endpoint in the pivotal trial.2

IGF-1 Normalization Responders§

  • 59% of patients experienced IGF-1 normalization at Week 52 (57/99)§

  • §IGF-1 data analyses were secondary endpoints of the pivotal trial.

EXTENDED DOSING INTERVALS (EDIs)1

Somatuline® Depot (lanreotide) Injection is the only somatostatin analog with FDA-approved EDI for controlled* patients†1,3

In an open-label, uncontrolled, multicenter, phase 3 trial3

Biochemical control was maintained with 120-mg dosing administered once every 6 or 8 weeks

*Controlled is defined as GH level from >1.0 ng/mL to ≤2.5 ng/mL, normalized IGF-1 level, and satisfactory management of clinical symptoms as determined by the healthcare professional.

Patients who are controlled with Somatuline Depot 60 mg or 90 mg administered every 4 weeks can be considered for treatment with 120 mg administered every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response. Continued monitoring of patients’ response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

Study design: In an open-label, comparative, multicenter, phase 3 trial, Somatuline® Depot (lanreotide) Injection 120 mg was administered every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. Of patients whose levels were controlled (GH ≤2.5 ng/mL and normalized IGF-1) when switched to extended dosing intervals (n=32), 5 out of 6 remained controlled after 3 injections at 6-week intervals and 23 out of 26 remained controlled after 3 injections at 8-week intervals.

PHARMACOKINETIC (PK) PROFILE

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EFFECTIVE PHARMACOKINETIC (PK) PROFILE MAINTAINED THROUGHOUT EDIs

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Pharmacokinetic (PK) profile

PHARMACOKINETIC (PK) PROFILE DURING EXTENDED DOSING INTERVALS3

Cmin of lanreotide after a single deep subcutaneous injection in healthy volunteers (mean ± SD)

Study design: In a phase 1, single-center, open-label, randomized, parallel-group study, the pharmacokinetic profile of a single injection of lanreotide was assessed in healthy volunteers at a dose of 120 mg (n=12) through 56 days (8 weeks).

In patients treated with Somatuline Depot 120 mg:

  • Serum concentrations (Cmin) through 6- and 8-week dosing intervals3

Study design: In open-label, comparative, multicenter, phase 3 trials, eligible patients who responded to SSAs received 3 to 5 injections of Somatuline Depot 120 mg. Somatuline Depot 120 mg was injected every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. There was no washout period or dose titration.

IMPORTANT SAFETY INFORMATION

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.
  • Hypoglycemia or Hyperglycemia
    • Pharmacological studies show that SOMATULINE DEPOT, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. 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 occurring in greater than or equal to 9% of patients who received SOMATULINE DEPOT in the overall pooled safety studies in acromegaly were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reactions (9%).

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.

INDICATIONS

SOMATULINE® DEPOT (lanreotide) Injection 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.

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.

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

References:

  1. Somatuline Depo (lanreotide) Injection [US Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.
  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. Acromegaly. N Engl J Med. 2006;355:2558-2573.
  6. National Endocrine and Metabolic Diseases Information Service. Acromegaly. National Institute of Diabetes and Digestive and Kidney Diseases. www.endocrine.niddk.nih.gov/pubs/acro/acromegaly_508/pdf. Accessed September 20, 2016
  7. Bronstein M, Musolino N, Jallad R, et al. Pharmacokinetic profile of lanreotide autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 days. Clin Endocrinol. 2005;63:514-519.

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Indication

SOMATULINE® DEPOT (lanreotide) Injection 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.

Contraindications

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PRIOR TREATMENT STATUS (refers to medication only)

Study included a diverse range of patient types2

NOTE: Patients either were not candidates for surgery or had had surgery and required further control.

The procedure for injecting Somatuline® Depot (lanreotide) Injection used for treating acromegaly is explained in this illustration.

Device not shown at actual size

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