OCTREOTIDE- octreotide acetate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTREOTIDE ACETATE (UNII: 75R0U2568I) (OCTREOTIDE - UNII:RWM8CCW8GP)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

OCTREOTIDE ACETATE

Composition:

OCTREOTIDE 50 ug in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Octreotide Acetate 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 surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of GH and IGF-1 (somatomedin C) levels (see DOSAGE AND ADMINISTRATION) . In patients with acromegaly, Octreotide Acetate Injection reduces GH to within normal ranges in 50% of patients and reduces IGF-1 (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Octreotide Acetate Injection to reduce blood levels of GH and IGF-1 (somatomedin C) offers potential benefit before the effects of irradiation are manifested. Improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trial

Product summary:

Octreotide Acetate Injection is available in 1 mL single dose vials packaged in tens in covered trays and 5 mL multiple dose vials packaged in individual cartons as follows: Preservative Free Single Dose Vials: Preserved Multiple Dose Vials: For prolonged storage, octreotide acetate single dose and multiple dose vials should be stored at refrigerated temperatures 2°C to 8°C (36°F to 46°F) and protected from light. At room temperature (20°C to 30°C or 70°F to 86°F), octreotide acetate injection is stable for 14 days if protected from light. The solution can be allowed to come to room temperature prior to administration. Do not warm artificially. After initial use, multiple dose vials should be discarded within 14 days. Single dose vials should be opened just prior to administration and the unused portion discarded. Dispose unused product or waste properly. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451028K Revised: March 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OCTREOTIDE - OCTREOTIDE ACETATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
OCTREOTIDE ACETATE INJECTION
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
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 (intrafat) or intravenous (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→7)-disulfide; [R-(R*,
R*)] acetate salt, is a long-acting octapeptide with pharmacologic
actions mimicking
those of the natural hormone somatostatin.
Octreotide Acetate Injection is available as: sterile 1 mL single dose
vials in 2 strengths,
containing 100 mcg and 500 mcg octreotide (as acetate), and sterile 5
mL multiple dose
vials in 2 strengths, containing 200 mcg/mL and 1,000 mcg/mL of
octreotide (as
acetate).
Each mL of the single dose vial also contains:
Each mL of the multiple dose vials also contains:
The molecular weight of octreotide acetate is 1019.3 g/mol (free
peptide,
C
H
N
O
S ) and its amino acid sequence is:
CLINICAL PHARMACOLOGY:
Octreotide Acetate Injection exerts pharmacologic actions similar to
the natural
hormone, somatostatin. It is an even more potent inhibitor of growth
hormone (GH),
sodium chloride . . . . . . . . . . . . . . . . . 7 mg
glacial acetic acid, USP . . . . . . . . . . . 2 mg
sodium acetate trihydrate, USP . . . . . 2 mg
water for injection, USP . . . . . . .qs to 1 mL
sodium chloride . . . . . . . . . . . . . . . . . 7 mg
glacial acetic acid, USP . . . . . . . . . . . 2 mg
sodium acetate trihydrate, USP . . . . . 2 mg
phenol, USP . . . . . . . . . . . . . . . . . . . . 5 mg
water for injection, USP . . . . . . . qs to 1 mL
49
66
10
10 2
glucagon, and insulin than somatostatin. Like somatostatin, it also
suppresses luteinizing
hormone (LH) response to gonadotropin releasing hormone (GnRH),
decreases
splanchnic bl