Somatuline

Acromegaly: Long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. GEP-NET: Treatment of adults with unresectable, well- or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

GEP-NET: 120 mg deep subcutaneous injection in the gluteal region every 4 weeks. Acromegaly: Start at 90 mg deep SC every 4 weeks for 3 months, then adjust to 60, 90, or 120 mg every 4 weeks based on response (GH levels, IGF-1, symptoms). May extend dosing interval to every 6 or 8 weeks in well-controlled patients.

Solution for injection (deep SC): 60 mg/0.4 mL, 90 mg/0.4 mL, 120 mg/0.5 mL — prefilled syringe

None established in prescribing information for the approved indications.

• Cholelithiasis and Gallbladder Complications: Gallstones, biliary sludge, and gallbladder-related events reported in up to 20% of patients. Monitoring with ultrasound recommended.
• Hyperglycemia/Hypoglycemia: Blood glucose alterations. Monitor glucose levels, especially in patients with diabetes.
• Hypothyroidism: Thyroid function should be monitored in long-term use.
• Bradycardia: Cardiac conduction abnormalities including bradycardia have been reported.
• Diarrhea/GI Effects: Diarrhea is common; steatorrhea and fat malabsorption may occur.
• Tumor Lysis in Acromegaly: GH-secreting pituitary tumor shrinkage with visual field changes reported.

Diarrhea (37%), Cholelithiasis (20%), Abdominal pain (19%), Nausea (11%), Injection site reaction (22%), Hyperglycemia (7%), Bradycardia (3%), Fatigue (6%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Cyclosporine: Lanreotide may reduce cyclosporine levels; monitor.
Antidiabetic agents: Glucose-altering effects may necessitate dose adjustments of antidiabetics.
Bromocriptine: Concomitant use may increase bioavailability of bromocriptine.

Can cause fetal harm. Advise females of reproductive potential to use effective contraception. Consult the full prescribing information for pregnancy risk details.

Advise women not to breastfeed during treatment and for a period after the last dose. Refer to prescribing information for duration guidance.

Safety and effectiveness in pediatric patients have not been established unless otherwise noted in the full prescribing information.

Dose modifications for organ impairment are specified in the complete prescribing information.

Lanreotide is a synthetic cyclic octapeptide analog of somatostatin. It binds to somatostatin receptors (SSTR2 and SSTR5 predominantly), inhibiting GH secretion from pituitary adenomas and suppressing the secretion of multiple hormones/growth factors including IGF-1, insulin, glucagon, gastrin, and VIP. In GEP-NETs, it inhibits tumor cell proliferation through antiproliferative and antisecretory mechanisms.

Route: Deep SC (extended-release microparticle formulation). Slow release provides prolonged drug levels. Tmax: ~24–48 hours after SC injection. Protein binding: 79–89%. Half-life: ~23–30 days (allowing monthly dosing). Elimination: primarily fecal with minor renal excretion. Steady state: after 4–5 doses.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• CLARINET — Lanreotide vs placebo for progression-free survival in nonfunctioning GEP-NETs. Phase III, n=204.
  🔬 NCT00353496 ↗📄 Primary Publication ↗

Somatuline has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: