lanreotide acetate
lanreotide acetate is listed in the FDA National Drug Code directory with 10 NDC codes, marketed under brand names including SOMATULINE DEPOT, Lanreotide Acetate. Available dosage forms: injection, powder.
Drug Details
- Generic Name
- lanreotide acetate
- Brand Names
- SOMATULINE DEPOT, Lanreotide Acetate
- Application Number
- NDA022074
- Sponsor
- Ipsen Biopharmaceuticals, Inc.
- NDC Codes
- 10
- Dosage Forms
- INJECTION, POWDER
- Routes
- SUBCUTANEOUS
- Active Ingredients
- LANREOTIDE ACETATE
Indications and Usage
1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. ( 1.2 ) the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. ( 1.3 ) 1.1 Acromegaly SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal. 1.2 Gastroenteropancreatic Neuroendocrine Tumors SOMATULINE DEPOT is indicated for the treatment of adult patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. 1.3 Carcinoid Syndrome SOMATULINE DEPOT is indicated for the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.