Generic Name
Octreotide Acetate
Brand Names
Octreotide, Sandostatin, Bynfezia
FDA approval date: October 21, 1988
Classification: Somatostatin Analog
Form: Injection, Kit
What is Octreotide (Octreotide Acetate)?
BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone and insulin growth factor 1 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. Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. Vasoactive Intestinal Peptide Tumors : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors. 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 octreotide injection; these trials were not optimally designed to detect such effects.
Approved To Treat
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Brand Information
Octreotide (OCTREOTIDE ACETATE)
1DOSAGE FORMS AND STRENGTHS
Octreotide Acetate Injection: 100 mcg per mL or 500 mcg per mL single-dose vial.
2CONTRAINDICATIONS
Sensitivity to this drug or any of its components.
3Drug Metabolism Interactions
Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of GH. Since it cannot be excluded that octreotide may have this effect, other drugs mainly metabolized by CYP3A4 and which have a low therapeutic index (e.g., quinidine, terfenadine) should therefore be used with caution.
4Lutetium Lu 177 Dotatate Injection
Octreotide competitively binds to somatostatin receptors and may interfere with the efficacy of lutetium Lu 177 dotatate. Discontinue Octreotide Acetate Injection at least 24 hours prior to each lutetium Lu 177 dotatate dose.
5OVERDOSAGE
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.
6DESCRIPTION
Octreotide Acetate Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl)propyl]-, cyclic (2
Octreotide Acetate Injection is available as: sterile 1 mL single dose vials in 2 strengths, containing 100 mcg and 500 mcg octreotide (as acetate). Each mL of the single dose vial also contains:
- sodium chloride…………………..……... 7 mg
- glacial acetic acid, USP ………………… 2 mg
- sodium acetate trihydrate, USP ………… 2 mg
- water for injection, USP ……………qs to 1 mL
The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C
7PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
NDC 63323-376-41 PRX370601
Octreotide Acetate Injection
100 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
Protect from light.
Discard unused portion.
1 mL Single Dose Vial Rx only
8PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label
NDC 63323-376-04 PRX370601
Octreotide Acetate Injection
100 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
10 x 1 mL
Single Dose Vials Rx only
9PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Label
NDC 63323-377-41 PRX370701
Octreotide Acetate Injection
500 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
Protect from light.
Discard unused portion.
1 mL Single Dose Vial Rx only
10PACKAGE LABEL - PRINCIPAL DISPLAY - Octreotide 1 mL Single Dose Vial Tray Label
NDC 63323-377-04 PRX370701
Octreotide Acetate Injection
500 mcg per mL
For Subcutaneous or Intravenous Use
Preservative free.
10 x 1 mL
Single Dose Vials Rx only
