lanreotide

REMS

Long-term management of acromegaly that 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.

Action ⬆ ⬇

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.

Therapeutic effects:

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.

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	first 24 hr	1 mo

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

CV: bradycardia, hypertension

Endo: hyperglycemia, hypoglycemia, hypothyroidism

GI: abdominal pain, cholelithiasis, diarrhea, abdominal bloating, cholecystitis, fat malabsorption, PANCREATITIS, steatorrhea, stool discoloration

Hemat: anemia

Local: injection site reactions

Metab: weight loss

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)

Interactions ⬆ ⬇

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.

Route/Dosage ⬆ ⬇

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.
SC (Adults ): CCr <60 mL/min or moderate to severe hepatic impairment: 60 mg every 4 wk; further adjustments are made on the basis of GH and IGF-1 levels.

GEP-NETs and Carcinoid Syndrome

SC (Adults ): 120 mg every 4 wk.

Availability ⬆ ⬇

(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

Assessment ⬆ ⬇

Assess for GI side effects (diarrhea, abdominal pain, nausea, gas, constipation); usually decrease with continued treatment.
Monitor for steatorrhea (excess fat in stool), abdominal bloating, and weight loss.If new occurrence or worsening of these symptoms occurs,evaluate for pancreatic exocrine insufficiency and provide appropriate medical management.
Monitor HR for pre-existing and new bradycardia prior to and periodically during therapy. If symptomatic bradycardia occurs,initiate appropriate medical management.
Monitor patients for symptoms of hypoglycemia when therapy is initiated or altered. May require adjustments to antidiabetic treatment.
Assess for right upper quadrant or radiating pain, and monitor gallbladder and bile duct ultrasound prior to and periodically during prolonged therapy. If cholelithiasis complications occur,discontinue lanreotide and treat appropriately.

Lab Test Considerations:

Monitor serum GH and IGF-1 levels every 3 mo.
- Monitor blood glucose when therapy is initiated and altered.
- May cause slight ↓ thyroid function; monitor as clinically indicated.
- May cause anemia.

Implementation ⬆ ⬇

Intended for administration by health care professional.
SC: Store in refrigerator and protect from light. Remove sealed pouch from refrigerator 30 min prior to injection; allow to reach room temperature. Syringes contain a white to pale yellow semisolid formulation. Administer deep into SUBQ tissue of superior external buttock. Do not fold skin; insert needle perpendicular to skin, rapidly to full length. Alternate injection between right and left side. Syringe is for single use. Sealed pouch left at room temperature for up to 72 hr may be returned to refrigerator for future use.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before receiving first injection and before each monthly injection in case of changes. If an injection is missed, consult health care professional.
Advise 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 medications.
Advise patient to notify health care professional if signs and symptoms of gallstones, hyperglycemia, hypoglycemia, thyroid dysfunction, or irregular heartbeat occur.
Advise patient to notify health care professional immediately if hypersensitivity reactions (swelling of face, lips, mouth, or tongue; breathing problems; fainting; dizziness; feeling lightheaded; itching; flushing or redness of skin; rash; hives) occur.
Advise patient to notify health care professional if they experience new or worsening symptoms of fat in their stool, stool discoloration, loose stools, abdominal bloating, or weight loss.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 6 mo after last dose. May fertility in females.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased levels of GH and IGF-1 in patients with acromegaly.
Improve progression-free survival in patients with GEP-NETs.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

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

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇