New Indication for Somatuline Depot
September 18, 2017 – The U.S. FDA has approved a new indication for Somatuline® Depot (lanreotide), manufactured by Ipsen Biopharmaceuticals, to treat adult carcinoid syndrome. Carcinoid syndrome is typically seen in patients who have advanced neuroendocrine tumors that secrete serotonin and other substances in the body. This can lead to severe diarrhea, rapid heartbeat, skin reactions, and difficulty breathing. These effects can be triggered by stress, exertion, and consumption of alcohol. At present, treatment options for carcinoid syndrome are limited.
Originally approved in 2007 to treat acromegaly—a condition in which excess growth hormone secretion leads to uncontrolled growth of the face, feet, and hands—Somatuline Depot is also indicated to treat neuroendocrine tumors of the gastro-entero-pancreatic system (GEP-NETs). Recommended dosing depends on the indication; the drug is delivered as a deep subcutaneous injection, and must be administered by a healthcare professional.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.