Safety and tolerability
Somatuline® Depot (lanreotide) Injection is generally well-tolerated therapy with a low discontinuation rate
Only 1.9% of patients (N=416) withdrew due to treatment-related adverse events1,2*
- Local side effects of Somatuline® Depot (lanreotide) Injection were mild to moderate and transient
- Gastrointestinal adverse events were also mild to moderate and were not dose-related
- Inhibition of gallbladder contractility is a known effect of the drug class of somatostatin analogs
Somatuline® Depot (lanreotide) Injection has a low incidence of cardiac adverse drug reactions
Most patients who experienced cardiac adverse events also had underlying cardiac disease.
Somatuline® Depot (lanreotide) Injection has a low incidence of hypoglycemia and hyperglycemia
Only 1.2% and 0.5% of patients reported hypoglycemia and hyperglycemia, respectively1,2*
* Pooled data from seven safety studies with Somatuline® Depot (lanreotide) Injection in 416 patients with acromegaly. One study was a fixed-dose pharmacokinetic study. The other six studies were open-label or extension studies. One study had a placebo-controlled run-in, and another had an active control. The median average monthly dose of Somatuline® Depot (lanreotide) Injection was 91.2 mg over 385 days with a median cumulative dose of 1,290 mg.
Indication and Important Safety Information
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 or cannot be treated with surgery and/or radiotherapy.
Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.
Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60 mg.
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus.
A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.
Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of coadministered drugs. Caution should be used.
The most common adverse reactions (incidence >5%) are diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), flatulence (7%), arthralgia (7%), and loose stools (6%).
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