{ "query": "octreotide", "ingredient": "octreotide", "slug": "octreotide", "rxcui": "7617", "brands": [ "Mycapssa", "Sandostatin", "Bynfezia" ], "names": [ "octreotide", "octreotide acetate" ], "classes": [ { "id": "H01CB", "name": "Somatostatin and analogues" } ], "alternatives": [ "lanreotide", "paltusotine", "pasireotide", "somatostatin" ], "label": { "route_mode": "SUBCUTANEOUS", "route_counts": { "SUBCUTANEOUS": 11, "INTRAVENOUS": 10, "ORAL": 2 }, "boxed_warning": "", "indications_and_usage": "Sandostatin Injection is a somatostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. ( 1.1 ) Carcinoid Tumors : For the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. ( 1.2 ) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. ( 1.3 ) Limitations of Use Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with Sandostatin Injection; these trials were not optimally designed to detect such effects. ( 1.4 ) 1.1 Acromegaly Sandostatin Injection is indicated to reduce blood levels of growth hormone (GH) and insulin growth factor-1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgic...", "contraindications": "Sensitivity to this drug or any of its components. Sensitivity to this drug or any of its components. ( 4 )", "warnings_and_cautions": "Cardiac Function Abnormalities : Increased risk for higher degree of atrioventricular blocks. Consider cardiac monitoring in patients receiving Sandostatin Injection intravenously. Bradycardia, arrhythmias, or conduction abnormalities may occur. Use with caution in at-risk patients. Dosage adjustment of cardiac medications may be necessary. ( 5.1 ) Cholelithiasis and Complications of Cholelithiasis : Monitor periodically. Discontinue if complications of cholelithiasis are suspected. ( 5.2 ) Glucose Metabolism : Hypoglycemia or hyperglycemia may occur. Glucose monitoring is recommended and anti-diabetic treatment may need adjustment. ( 5.3 ) Thyroid Function : Hypothyroidism may occur. Monitor thyroid levels periodically. ( 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. ( 5.5 ) 5.1 Cardiac Function Abnormalities Complete Atrioventricular Block Patients who receive Sandostatin Injection intravenously may be at increased risk for higher degree atrioventric...", "warnings": "", "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Complete Atrioventricular Block [see Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [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 (5.5)] Changes in Vitamin B12 Levels [see Warnings and Precautions (5.6)] Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism. In other patients, most common adverse reactions (incidence > 10%) are gallbladder abnormalities. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 trials of a drug cannot be directly c...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "Warnings and Precautions, Steatorrhea and Malabsorption of Dietary Fats ( 5.5 ) 7/2024", "information_for_patients": "Sterile Subcutaneous Injection Technique Careful instruction in sterile subcutaneous injection technique should be given to the patients and to other persons who may administer Sandostatin Injection. Cholelithiasis and Complications of Cholelithiasis Advise patients to contact their healthcare provider if they experience signs or symptoms of gallstones (cholelithiasis) or complications of cholelithiasis (e.g., cholecystitis, cholangitis, and pancreatitis) [see Warnings and Precautions (5.2)] . Steatorrhea and Malabsorption of Dietary Fats Advise patients to contact their healthcare provider if they experience new or worsening of steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss [see Warnings and Precautions (5.5)] . Pregnancy Inform female patients that treatment with Sandostatin Injection may result in unintended pregnancy [see Use in Specific Populations (8.3)] . Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 \u00a9 Novartis T2024-50", "spl_medguide": "", "clinical_studies": "", "brand_name": "Sandostatin", "manufacturer": "Novartis Pharmaceuticals Corporation", "application_number": "NDA019667", "pharm_class_epc": [], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "effective_time": "20260722", "set_id": "4e2c9856-1836-49f0-9472-4dbeeb408f39", "has_boxed_warning": false, "boxed_labels": "0 of 11", "controlled": false, "mentions_rems": false }, "faers": { "total": 29071, "serious": 21764, "death": 5657, "hospitalization": 9678, "primary_suspect": 29054, "top_reactions": [ [ "Diarrhoea", 4294 ], [ "Death", 4066 ], [ "Fatigue", 3416 ], [ "Malaise", 2967 ], [ "Blood Pressure Increased", 2937 ], [ "Nausea", 2835 ], [ "Needle Issue", 2788 ], [ "Pain", 2529 ], [ "Malignant Neoplasm Progression", 2425 ], [ "Blood Pressure Systolic Increased", 2371 ], [ "Abdominal Pain", 2364 ], [ "Weight Decreased", 2214 ], [ "Injection Site Pain", 2187 ], [ "Asthenia", 2184 ], [ "Headache", 2033 ] ], "by_year": { "2019": 2936, "2020": 3407, "2021": 2912, "2022": 1784, "2023": 1712, "2024": 1032, "2025": 1225, "2026": 580 }, "by_year_primary": { "2019": 2935, "2020": 3407, "2021": 2910, "2022": 1781, "2023": 1712, "2024": 1025, "2025": 1225, "2026": 577 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class II", "date": "20260424", "reason": "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20260317", "reason": "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20260317", "reason": "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class II", "date": "20260317", "reason": "Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.", "firm": "Teva Pharmaceuticals USA, Inc", "status": "Ongoing" }, { "class": "Class I", "date": "20221007", "reason": "Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.", "firm": "Viatris Inc", "status": "Terminated" } ], "recall_total": 5, "drugsfda": { "applications": 27, "nda": 4, "anda": 23, "first_approval": "19881021", "rems": false, "rems_last": "", "labeling_supplements": 32, "labeling_recent": 9, "sponsors": [ "CHIESI", "FRESENIUS KABI USA", "GLAND", "HERITAGE", "MEITHEAL", "MYLAN INSTITUTIONAL", "MYLAN LABS LTD", "NOVARTIS" ], "unapproved": false, "first_approval_fmt": "10/21/1988" }, "trials": { "total": 327, "completed": 193, "terminated": 53, "with_results": 67, "industry": 132, "phase3": 74, "results_share": 0.3471502590673575, "terminated_share": 0.1620795107033639 }, "pubmed": { "rct": 359, "meta": 40, "recent_rct": 23, "cochrane": [ { "pmid": "20824848", "title": "Octreotide for the treatment of chylothorax in neonates", "year": "2010" }, { "pmid": "10796699", "title": "Somatostatin or octreotide for acute bleeding oesophageal varices", "year": "2000" } ] }, "payments": { "year": "2024", "usd": 408859.79, "records": 1260, "by_name": [ [ "Mycapssa", 237334.86 ], [ "Sandostatin", 171524.93 ] ], "names_checked": [ "octreotide", "Mycapssa", "Sandostatin", "Bynfezia" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 15843, "beneficiaries": 3596, "spend": 15382033.22, "by_brand": [ { "brand": "Octreotide Acetate", "claims": 14690, "per_claim": 379.24141593, "is_generic": true }, { "brand": "Mycapssa", "claims": 1051, "per_claim": 9147.5142721, "is_generic": false }, { "brand": "Sandostatin", "claims": 102, "per_claim": 1930.7776471, "is_generic": false } ], "per_claim": 970.9040724610238 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": true, "status": "AddedToEml", "name": "octreotide", "matched": "octreotide", "stewardship": [] }, "exposure": null, "scores": { "safety": { "score": 82, "letter": "B", "why": [ "Death appears in 2.1x the share of reports seen across all of FAERS (-8)", "1 Class I recall(s): reasonable probability of serious harm (-10)" ], "weight": 0.35 }, "evidence": { "score": 64, "letter": "C", "why": [ "359 randomized trials and 40 systematic reviews/meta-analyses indexed in PubMed", "On the WHO Model List of Essential Medicines (shown for context; no score effect)", "2 independent Cochrane review(s) exist", "Only 35% of completed registered trials posted results (-15)" ], "weight": 0.25 }, "regulatory": { "score": 60, "letter": "D", "why": [ "Recalls since 2016: 1 Class I, 4 Class II, 0 Class III across 23 generic makers (-27)", "9 label changes approved since 2021: the safety story is still moving (-8)", "Label lists recent major changes to warnings or indications (-5)" ], "weight": 0.15 }, "conflict": { "score": 85, "letter": "B", "why": [ "Pharma paid doctors $408,860 tied to this drug last year (-15)", "Not named in any pending federal MDL" ], "weight": 0.15 }, "options": { "score": 100, "letter": "A", "why": [ "Generic versions approved (23 applications)", "4 same-class alternatives exist" ], "weight": 0.1 } }, "total": 76, "grade": "B", "questions": [ "The most-reported problems in FDA's adverse event data are diarrhoea, death, fatigue, malaise. How would we recognize and handle those?", "Why this one over lanreotide, 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.)" ] }