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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 (lanreotide) Injection may experience hypoglycemia or hyperglycemia. Glucose levels 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 (lanreotide) Injection 60mg.
There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline® Depot (lanreotide) Injection 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 (lanreotide) Injection may reduce the intestinal absorption of co-administered drugs. Caution should be used.
The most common adverse reactions (incidence >5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.
Please see Full Prescribing Information for additional important information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
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