Somatuline Depot

lanreotide

(lan-ree-o-tide) ,

Somatuline Depot

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: somatostatin analogues
Pregnancy Category: C

Indications

Long-term management of acromegaly which cannot be treated by or has not responded to surgery and/or radiation therapy.

Action

Acts as an analog of somatostatin, inhibiting growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in patients with acromegaly.

Therapeutic effects

Decreased levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1) in acromegalic patients resulting in decreased manifestations of acromegaly.

Pharmacokinetics

Absorption: Following subcut administration, lanreotide precipitates in body tissues acting as a depot formulation from which drug is slowly released (75% bioavailability).
Distribution: Unknown.
Metabolism and Excretion: Minimal renal/fecal excretion, some biliary excretion.
Half-life: 23–30 days.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutunknownfirst 24 hr1 mo

Contraindications/Precautions

Contraindicated in: Obstetric: Lactation.
Use Cautiously in: Diabetic patients; Underlying heart disease, especially bradycardia; Obstetric: Use only if maternal benefit outweighs risk to fetus; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Cardiovascular

  • bradycardia
  • hypertension

Gastrointestinal

  • pancreatitis (life-threatening)
  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • gallstones (most frequent)

Endocrinologic

  • hyperglycemia
  • hypoglycemia

Hematologic

  • anemia

Local

  • injection site reactions (most frequent)

Interactions

Drug-Drug interaction

↑ 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

Subcutaneous (Adults) 90 mg every 4 week for 3 mo, further adjustments are made on the basis of GH and IGF1 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.

Hepatic/Renal Impairment

Subcutaneous (Adults) Moderate to severe hepatic or renal impairment—60 mg every 4 wk; further adjustments are made on the basis of GH and IGF1 levels.

Availability

Semi-solid in pre-filled syringes: 60 mg, 90 mg, 120 mg

Nursing implications

Nursing assessment

  • Assess for GI side effects (diarrhea, abdominal pain, nausea, gas, constipation); usually decrease with continued treatment.
  • Lab Test Considerations: Monitor serum growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels every 3 mo.
    • May cause hyperglycemia or hypoglycemia. Monitor blood glucose when therapy is initiated and when dose is altered and adjust antidiabetic treatment accordingly.
    • May cause slight ↓ thyroid function; monitor as clinically indicated.
    • May cause anemia.

Potential Nursing Diagnoses

Risk for disproportionate growth (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Subcutaneous: Store in refrigerator and protect from light. Remove sealed pouch from refrigerator 30 min prior to injection; allow to reach room temperature. Keep pouch sealed until injection. Administer deep into subcutaneous 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. May cause injection site reactions (pain, injection site mass); decrease with continued therapy. Syringe is for single use; do not use after expiration date.

Patient/Family Teaching

  • 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.
  • Instruct patient to notify health care professional if unusual symptoms develop or known symptoms persist or worsen.
  • 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.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decreased levels of growth hormone (GH) and insulin-like growth factor-1 (IGF-1).

Somatuline Depot

a trademark for lanreotide.
Mentioned in ?
References in periodicals archive ?
In 81 patients with baseline heart rates of >/= 60 beats per minute (bpm) treated with Somatuline DEPOT in the GEP-NETs clinical trial, the incidence of heart rate < 60 bpm was 23% (19/81) with Somatuline vs 16% (15/94) with placebo; 10 patients (12%) had documented heart rates < 60 bpm on more than one visit.
Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels.
In the GEP-NET pivotal trial, the most common adverse reactions (incidence >10% and more common than placebo) in patients treated with Somatuline DEPOT vs placebo were abdominal pain (34% vs 24%), musculoskeletal pain (19% vs 13%), vomiting (19% vs 9%), headache (16% vs 11%), injection site reaction (15% vs 7%), hyperglycemia (14% vs 5%), hypertension (14% vs 5%), and cholelithiasis (14% vs 7%).
In the United States, the prolonged-release formulation of lanreotide, a synthetic octapeptide with biologic activity similar to that of naturally occurring somatostatin, is being marketed as Somatuline Depot.
The label cites two long-term, randomized multicenter studies of different doses of Somatuline Depot in patients with acromegaly.
During a 4-month fixed-dose phase, patients received four injections of 90 mg of Somatuline Depot every 4 weeks.
Somatuline Depot, which has been available in Europe, will be "a useful addition to our formularies," Dr.
Brisbane CA) won approval for its medicine, Somatuline Depot, as a treatment option for patients with acromegaly, a condition marked by excessive growth of the head and extremities.
The launch of Somatuline Depot is progressing well.
Then in August, Somatuline Depot was approved in the United States for the treatment of acromegaly, and Increlex was granted marketing authorization in the European Union for the treatment of severe Primary IGFD.
Along with continued positive commercial momentum for Increlex, we achieved two major corporate milestones in the third quarter when Somatuline Depot was approved in the United States for the treatment of acromegaly and Increlex was granted marketing authorization in the European Union for severe Primary IGFD," said John A.
Somatuline Depot is the only long-acting acromegaly therapy available in a pre-filled syringe, and the only long-acting somatostatin analogue that does not require reconstitution prior to injection.