• Long-term management of acromegaly which cannot be treated by or has not responded to surgery and/or radiation therapy.
• Unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
• Carcinoid syndrome.

Contraindicated in:

• Hypersensitivity
• Lactation: Lactation.

Use Cautiously in:

• Diabetes
• Underlying heart disease, especially bradycardia
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Pedi: Safety and effectiveness not established in children.

CV: bradycardia, hypertension.

Endo: hyperglycemia, hypoglycemia, hypothyroidism.

GI: abdominal pain, cholelithiasis, diarrhea, cholecystitis, PANCREATITIS.

Hemat: anemia.

Local: injection site reactions.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• ↑ risk of bradycardia with other drugs that may cause ↓ heart rate including beta-blockers.
• May ↓ absorption of cyclosporine (dose adjustment may be necessary).
• May alter the effects of antidiabetic agents (monitor blood sugar).
• May ↓ activity or CYP450 enzyme system, use cautiously with drugs metabolized by that system, including quinidine.

(Generic available)

• Semisolid for injection (prefilled syringes): 60 mg/0.2 mL; 60 mg/0.5 mL; 90 mg/0.3 mL; 90 mg/0.5 mL; 120 mg/0.5 mL;

Acromegaly

• SC (Adults): 90 mg every 4 wk for 3 mo, further adjustments are made on the basis of GH and IGF–1 levels as follows: GH > 1 to ≤2.5 ng/mL, IGF-1 normal with good symptom control: maintain dose at 90 mg every 4 wk;GH >2.5 ng/mL, IGF-1 elevated and/or uncontrolled symptoms: ↑ dose to 120 mg every 4 wk; GH ≤1 mg/mL, IGF-1 symptoms currently controlled : ↓ dose to 60 mg every 4 wk.

GEP-NETs and Carcinoid Syndrome

• SC (Adults): 120 mg every 4 wk.

Somatuline Depot

• Acts as an analog of somatostatin, inhibiting growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly. Also inhibits secretion of variety of other hormones secreted throughout gastrointestinal tract, including motilin, gastric inhibitory peptide, pancreatic polypeptide, gastrin, and cholecystokinin which could be fueling tumor growth.

• Decreased levels of GH and IGF-1 in patients with acromegaly resulting in decreased manifestations of acromegaly.
• Improve progression-free survival in patients with GEP-NETs.
• ↓ need for short-acting somatostatin analog rescue therapy.

Therapeutic Classification: hormones

Pharmacologic Classification: somatostatin analogues

Absorption: Following SUBQ administration, lanreotide precipitates in body tissues acting as a depot formulation from which drug is slowly released (75% bioavailability).

Distribution: Unknown.

Metabolism/Excretion: Minimal renal/fecal excretion, some biliary excretion.

Half-life: 23–30 days.

Somatuline Autogel

• Explain purpose of lanreotide to patient. Advise patient to read Patient Information before receiving first injection and before each monthly injection in case of new information. If an injection is missed, consult health care professional.
• Advise patient to notify health care professional if signs and symptoms of gallstones (sudden upper right abdominal pain, yellowing of skin and whites of eyes, nausea, sudden pain in right shoulder or between shoulder blades, fever with chills), hyperglycemia (increased thirst, increased appetite, nausea, weakness or tiredness, urinating frequently, breath smells like fruit), hypoglycemia (dizziness or lightheadedness, blurred vision, fast heartbeat, sweating, slurred speech, irritability or mood changes, confusion, shakiness, hunger, headache), hypothyroidism (fatigue, weight gain, puffy face, being cold frequently, constipation, dry skin, thinning, dry hair, decreased sweating, depression), or hypersensitivity reactions (swelling of face, lips, mouth or tongue; breathing problems; fainting; dizziness; feeling lightheaded; itching; flushing or redness of skin; rash; hives) occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during and for 6 mo after last dose. May impair fertility in females.

lan-REE-o-tide

NDC Code^*

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1060- SOMATULINE DEPOT
    • 15054-1060-3- 1 POUCH in 1 CARTON (15054-1060-3) > 1 SYRINGE in 1 POUCH >.2 mL in 1 SYRINGE

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1060- SOMATULINE DEPOT
    • 15054-1060-4- 1 POUCH in 1 CARTON (15054-1060-4) > 1 SYRINGE in 1 POUCH >.2 mL in 1 SYRINGE

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1090- SOMATULINE DEPOT
    • 15054-1090-3- 1 POUCH in 1 CARTON (15054-1090-3) > 1 SYRINGE in 1 POUCH >.3 mL in 1 SYRINGE

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1090- SOMATULINE DEPOT
    • 15054-1090-4- 1 POUCH in 1 CARTON (15054-1090-4) > 1 SYRINGE in 1 POUCH >.3 mL in 1 SYRINGE

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1120- SOMATULINE DEPOT
    • 15054-1120-3- 1 POUCH in 1 CARTON (15054-1120-3) > 1 SYRINGE in 1 POUCH >.5 mL in 1 SYRINGE

• 15054- Ipsen Biopharmaceuticals, Inc.
  • 15054-1120- SOMATULINE DEPOT
    • 15054-1120-4- 1 POUCH in 1 CARTON (15054-1120-4) > 1 SYRINGE in 1 POUCH >.5 mL in 1 SYRINGE