{ "query": "lanreotide", "ingredient": "lanreotide", "slug": "lanreotide", "rxcui": "68092", "brands": [ "Somatuline" ], "names": [ "lanreotide", "lanreotide acetate" ], "classes": [ { "id": "H01CB", "name": "Somatostatin and analogues" } ], "alternatives": [ "octreotide", "paltusotine", "pasireotide", "somatostatin" ], "label": { "route_mode": "SUBCUTANEOUS", "route_counts": { "SUBCUTANEOUS": 4 }, "boxed_warning": "", "indications_and_usage": "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 C...", "contraindications": "is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [ see Adverse Reactions (6.3) ] . Hypersensitivity to lanreotide. ( 4 )", "warnings_and_cautions": "Cholelithiasis and Complications of Cholelithiasis : Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Gallstones may occur; consider periodic monitoring. ( 5.1 ) Hyperglycemia and Hypoglycemia : Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly. ( 5.2 , 7.1 ) Cardiovascular Abnormalities : Decrease in heart rate may occur. Use with caution in at-risk patients. ( 5.3 ) Thyroid Function Abnormalities : Decreases in thyroid function may occur; perform tests where clinically indicated. ( 5.4 ) Steatorrhea and Malabsorption of Dietary Fats: New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency. ( 5.6 ) 5.1 Cholelithiasis and Complications of Cholelithiasis SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically [see Adverse Reactions (6.1) , Clinical Pharmacology (12.2) ] . There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, i...", "warnings": "", "adverse_reactions": "The following adverse reactions to SOMATULINE DEPOT are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.1) ] Hyperglycemia and Hypoglycemia [see Warnings and Precautions (5.2) ] Cardiovascular Abnormalities [see Warnings and Precautions (5.3) ] Thyroid Function Abnormalities [see Warnings and Precautions (5.4) ] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.6) ] Most common adverse reactions are: Acromegaly (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. ( 6.1 ) GEP-NET (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. ( 6.1 ) Carcinoid Syndrome : (\u22655% and at least 5% greater than placebo): headache, dizziness and muscle spasm. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical t...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings & Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.6 ) 07/2024", "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to immediately contact their healthcare provider if they experience serious hypersensitivity reactions, such as angioedema or anaphylaxis [see Contraindications (4) ] . Cholelithiasis and Complications of Cholelithiasis Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of gallstones (e.g., cholecystitis, cholangitis, or pancreatitis) [see Warnings and Precautions (5.1) ]. Hyperglycemia and Hypoglycemia Advise patients to immediately contact their healthcare provider if they experience signs or symptoms of hyper- or hypoglycemia [see Warnings and Precautions (5.2) ] . Cardiovascular Abnormalities Advise patients to immediately contact their healthcare provider if they experience bradycardia [see Warnings and Precautions (5.3) ]. Thyroid Function Abnormalities Advise patients to contact their healthcare provider if they experience signs or symptoms of hypothyroidism [see Warnings and Precautions (5.4) ]. Laboratory Tests Advise patients with acromegaly that response to SOM...", "spl_medguide": "", "clinical_studies": "14.1 Acromegaly The effect of SOMATULINE DEPOT on reducing GH and IGF-levels and control of symptoms in patients with acromegaly was studied in 2 long-term, multiple-dose, randomized, multicenter studies. Study 1 This 1-year study included a 4-week, double-blind, placebo-controlled phase; a 16-week single-blind, fixed-dose phase; and a 32-week, open-label, dose-titration phase. Patients with active acromegaly, based on biochemical tests and medical history, entered a 12-week washout period if there was previous treatment with a somatostatin analog or a dopaminergic agonist. Upon entry, patients were randomly allocated to receive a single, deep subcutaneous injection of SOMATULINE DEPOT 60, 90, or 120 mg or placebo. Four weeks later, patients entered a fixed-dose phase where they received 4 injections of SOMATULINE DEPOT followed by a dose-titration phase of 8 injections for a total of 13 injections over 52 weeks (including the placebo phase). Injections were given at 4-week intervals. During the dose-titration phase of the study, the dose was titrated twice (every fourth injection), as needed, according to individual GH and IGF-1 levels. A total of 108 patients (51 males, 57 female...", "brand_name": "SOMATULINE DEPOT", "manufacturer": "Ipsen Biopharmaceuticals, Inc.", "application_number": "NDA022074", "pharm_class_epc": [], "route": [ "SUBCUTANEOUS" ], "effective_time": "20241011", "set_id": "6e4a41fd-a753-4362-87ee-8cc56ed3660d", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 11252, "serious": 7320, "death": 1792, "hospitalization": 2855, "primary_suspect": 11247, "top_reactions": [ [ "Diarrhoea", 1981 ], [ "Off Label Use", 1899 ], [ "Death", 1433 ], [ "Fatigue", 1280 ], [ "Nausea", 1032 ], [ "Abdominal Pain", 868 ], [ "Injection Site Pain", 698 ], [ "Headache", 685 ], [ "Malaise", 655 ], [ "Asthenia", 621 ], [ "Vomiting", 596 ], [ "Weight Decreased", 596 ], [ "Pain", 562 ], [ "Drug Ineffective", 553 ], [ "Dizziness", 551 ] ], "by_year": { "2019": 782, "2020": 813, "2021": 1265, "2022": 1343, "2023": 1250, "2024": 915, "2025": 1059, "2026": 427 }, "by_year_primary": { "2019": 782, "2020": 813, "2021": 1265, "2022": 1343, "2023": 1250, "2024": 914, "2025": 1055, "2026": 427 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20260313", "reason": "Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.", "firm": "Cipla USA, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20260313", "reason": "Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.", "firm": "Cipla USA, Inc.", "status": "Ongoing" }, { "class": "Class II", "date": "20260102", "reason": "Presence of Particulate Matter.", "firm": "Cipla USA, Inc.", "status": "Ongoing" } ], "recall_total": 3, "drugsfda": { "applications": 4, "nda": 2, "anda": 2, "first_approval": "20070830", "rems": false, "rems_last": "", "labeling_supplements": 7, "labeling_recent": 2, "sponsors": [ "AMNEAL", "INVAGEN PHARMS", "IPSEN PHARMA" ], "unapproved": false, "first_approval_fmt": "08/30/2007" }, "trials": { "total": 118, "completed": 72, "terminated": 21, "with_results": 34, "industry": 82, "phase3": 39, "results_share": 0.4722222222222222, "terminated_share": 0.17796610169491525 }, "pubmed": { "rct": 55, "meta": 3, "recent_rct": 6, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "lanreotide", "Somatuline" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 7428, "beneficiaries": 1097, "spend": 66466429.12, "by_brand": [ { "brand": "Somatuline Depot", "claims": 6398, "per_claim": 9023.1398953, "is_generic": false }, { "brand": "Lanreotide Acetate", "claims": 1030, "per_claim": 8481.9223981, "is_generic": true } ], "per_claim": 8948.092234787291 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 92, "letter": "A", "why": [ "Death appears in 1.7x the share of reports seen across all of FAERS (-3)", "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)" ], "weight": 0.35 }, "evidence": { "score": 37, "letter": "F", "why": [ "55 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)", "Only 47% of completed registered trials posted results (-8)" ], "weight": 0.25 }, "regulatory": { "score": 82, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III (-9)", "2 label changes approved since 2021 (-4)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 100, "letter": "A", "why": [ "Pharma paid doctors $0 tied to this drug last year: negligible", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (2 applications)", "4 same-class alternatives exist" ], "weight": 0.1 } }, "total": 79, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are diarrhoea, death, fatigue. How would we recognize and handle those?", "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?", "Why this one over octreotide, paltusotine, pasireotide? What would make you pick one of those instead?", "What result are we expecting, by when, and what is the plan if it does not happen?", "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)" ] }