Octreotide Acetate
Generic Name: octreotide acetate
Brand Names:
Octreotide Acetate
11 DESCRIPTION Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection.
Overview
11 DESCRIPTION Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous or IV injection.
Uses
1 INDICATIONS AND USAGE 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. ( 1.2 ) • Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.
Dosage
2 DOSAGE AND ADMINISTRATION • Octreotide acetate injection may be administered subcutaneously or intravenously. ( 2.1 ) • Acromegaly : Recommended initial octreotide acetate 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.
Side Effects
6 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.
Interactions
7 DRUG INTERACTIONS • The following drugs require monitoring and possible dose adjustment when used with octreotide acetate injection : cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine. ( 7 ) • Lutetium Lu 177 Dotatate Injection : Discontinue octreotide acetate injection at least 24 hours prior to each lutetium Lu 177 dotatate dose. ( 7.6 ) 7.1 Cyclosporine Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs. Concomitant administration of octreotide acetate injection with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection. 7.2 Insulin and Oral Hypoglycemic Drugs Octreotide inhibits the secretion of insulin and glucagon.
Warnings
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS Sensitivity to this drug or any of its components. • Sensitivity to this drug or any of its components. ( 4 )
Pregnancy
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).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Octreotide acetate injection is available in 1 mL single-dose vials as follows: NDC Package 68462-896-10 100 mcg/mL octreotide (as acetate)-Package of 10 vials 68462-896-01 100 mcg/mL octreotide (as acetate)- 1mL Single-Dose Vial 68462-897-10 500 mcg/mL octreotide (as acetate)-Package of 10 vials 68462-897-01 500 mcg/mL octreotide (as acetate)- 1mL...
Frequently Asked Questions
What is Octreotide Acetate used for?▼
1 INDICATIONS AND USAGE 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. ( 1.2 ) • Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors.
What are the side effects of Octreotide Acetate?▼
6 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.
Can I take Octreotide Acetate during pregnancy?▼
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).
What are the important warnings for Octreotide Acetate?▼
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS Sensitivity to this drug or any of its components. • Sensitivity to this drug or any of its components. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.