pharmacopeia
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/api/v1/drug/octreotide

Mechanism of action

Sourced from openFDA

Octreotide acetate injection exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin.

Somatostatin Receptor

Indications

Sourced from openFDA
  • Octreotide Acetate 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.

Contraindications

Sourced from openFDA
  • Sensitivity to this drug or any of its components. Sensitivity to this drug or any of its components.contraindicated

Dosage & administration

Sourced from openFDA

Octreotide Acetate injection may be administered subcutaneously or intravenously. ( 2.1 ) Acromegaly : Recommended initial Octreotide Acetate injection dosage is 50 mcg three times daily during the initial 2 weeks of therapy. Maintenance dose 100 mcg to 500 mcg three times daily. ( 2.2 ) Carcinoid Tumors : Recommended dosage range of 100 mcg to 600 mcg daily in two to four divided doses during the initial 2 weeks of therapy. ( 2.3 ) VIPomas : Recommended dosage range of 200 mcg to 300 mcg daily in two to four divided doses during the initial 2 weeks of therapy. ( 2.4 ) 2.1 Dosage and Administration Overview Octreotide Acetate injection may be administered subcutaneously or intravenously. Pain with subcutaneous administration may be reduced by using the smallest volume that will deliver the desired dose. Sites should be rotated in a systematic manner. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulates and/or discoloration are observed. Octreotide Acetate injection is not compatible in Total Parenteral Nutrition solutions because of the formation of a glycosyl octreotide conjugate which may decrease the efficacy of the product. Octreotide Acetate injection may be diluted in volumes of 50 mL to 200 mL and infused intravenously over 15 to 30 minutes or administered by intravenous (IV) push over 3 minutes. In emergency situations (e.g., carcinoid crisis), it may be given by rapid bolus.

Warnings & precautions

Sourced from openFDA

Cardiac Function Abnormalities : Increased risk for higher degree of atrioventricular blocks. Consider cardiac monitoring in patients receiving octreotide acetate 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 octreotide acetate injection intravenously may be at increased risk for higher degree atrioventricular blocks. In postmarketing reports, complete atrioventricular block was reported in patients receiving IV octreotide acetate injection during surgical procedures. In the majority of patients, octreotide acetate injection was given at higher than recommended doses and/or as a continuous IV infusion.

Adverse reactions

Sourced from openFDA

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 Meitheal Pharmaceuticals Inc. at 1-844-824-8426 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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Gallbladder Abnormalities Gallbladder abnormalities, especially stones and/or biliary sludge, frequently develop in patients on chronic octreotide acetate injection therapy [see Warnings and Precautions (5.1)] .

Use in specific populations

Sourced from openFDA

Females and Males of Reproductive Potential : Advise premenopausal females of the potential for an unintended pregnancy. ( 8.3 ) 8.1 Pregnancy Risk Summary The limited data with octreotide acetate injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse developmental-effects were observed with IV administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7- and 13-times, respectively the maximum recommended human dose (MRHD) of 1.5 mg/day based on body surface area (BSA). Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at IV doses below the MRHD based on BSA ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data In postmarketing data, a limited number of exposed pregnancies have been reported in patients with acromegaly.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption After subcutaneous injection, octreotide is absorbed rapidly and completely from the injection site. Peak concentrations of 5.2 ng/mL (100-mcg dose) were reached 0.4 hours after dosing.

Overdosage

Sourced from openFDA

A limited number of accidental overdoses of octreotide acetate injection in adults have been reported. In adults, the doses ranged from 2,400 to 6,000 mcg/day administered by continuous infusion (100 to 250 mcg/hour) or subcutaneously (1,500 mcg 3 times a day). Adverse events in some patients included arrhythmia, complete atrioventricular block, hypotension, cardiac arrest, brain hypoxia, pancreatitis, hepatitis steatosis, hepatomegaly, lactic acidosis, flushing, diarrhea, lethargy, weakness, and weight loss. If overdose occurs, symptomatic management is indicated. Up-to-date information about the treatment of overdose can often be obtained from the National Poison Control Center at 1-800-222-1222.

Approval history

Sourced from openFDA
  • Oct 21, 1988NDANDA019667Novartis
  • Nov 25, 1998NDANDA021008Novartis
  • Mar 28, 2005ANDAANDA076313West-ward Pharms Int
  • Apr 8, 2005ANDAANDA076330West-ward Pharms Int
  • Oct 3, 2005ANDAANDA075957Meitheal
  • Feb 10, 2006ANDAANDA077450Fresenius Kabi Usa
  • Jun 26, 2020NDANDA208232Chiesi
  • Sep 27, 2024NDANDA213224Sun Pharm

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
30,512 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea4,55315%
  2. 2Death4,17814%
  3. 3Fatigue3,50811%
  4. 4Malaise3,0089.9%
  5. 5Nausea2,9739.7%
  6. 6Blood Pressure Increased2,9669.7%
  7. 7Needle Issue2,7749.1%
  8. 8Pain2,5848.5%
  9. 9Abdominal Pain2,4648.1%
  10. 10Malignant Neoplasm Progression2,4588.1%
  11. 11Blood Pressure Systolic Increased2,3867.8%
  12. 12Asthenia2,2717.4%
  13. 13Weight Decreased2,2677.4%
  14. 14Injection Site Pain2,1877.2%
  15. 15Headache2,0846.8%

Literature

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Recent PubMed references pinned to Octreotide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 324 ClinicalTrials.gov registrations naming Octreotide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Octreotide work?
Octreotide acetate injection exerts pharmacologic actions similar to the natural hormone, somatostatin. It is an even more potent inhibitor of GH, glucagon, and insulin than somatostatin.
What is Octreotide used for?
According to FDA labeling, Octreotide carries indications including: Octreotide Acetate 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Octreotide?
Octreotide is classified as Somatostatin and analogues, Somatostatin Analog, Somatostatin Receptor Agonists, Decreased Gastrin Activity, Decreased Glucagon Secretion, Decreased Growth Hormone Secretion, Decreased Insulin Secretion, Decreased Thyroid Stimulating Hormone Secretion, Serotonin Activity Alteration.
What are the brand names for Octreotide?
Octreotide is marketed under brand names including Bynfezia, Mycapssa, Sandostatin.
What are the contraindications for Octreotide?
Octreotide labeling lists contraindications including: Sensitivity to this drug or any of its components. Sensitivity to this drug or any of its components.. Always consult the full prescribing information and a clinician.
Note. Data for octreotide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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