KINEVAC- sincalide injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sincalide (UNII: M03GIQ7Z6P) (Sincalide - UNII:M03GIQ7Z6P)

Available from:

Bracco Diagnostics Inc.

INN (International Name):

Sincalide

Composition:

Sincalide 5 ug in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Kinevac is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. KINEVAC is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)] . - intestinal obstruction. Risk Summary Based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous

Product summary:

Kinevac (sincalide for injection) is supplied as 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial; in packages of 10 vials (NDC 0270-0556-15). Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

KINEVAC- SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
BRACCO DIAGNOSTICS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KINEVAC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KINEVAC
KINEVAC (SINCALIDE FOR INJECTION), FOR INTRAVENOUS USE INITIAL U.S.
APPROVAL: 1976
RECENT MAJOR CHANGES
Contraindications (4)
10/2023
Warnings and Precautions (5.1)
10/2023
       Anaphylaxis, Anaphylactic Shock and Other Serious
Hypersensitivity Reactions (5.1)
10/2023
INDICATIONS AND USAGE
Kinevac is a cholecystokinin (CCK) analog indicated in adults to:
stimulate gallbladder contraction, as may be assessed by various
methods of diagnostic imaging, or to
obtain by duodenal aspiration a sample of concentrated bile for
analysis of cholesterol, bile salts,
phospholipids, and crystals. (1)
stimulate pancreatic secretion in combination with secretin prior to
obtaining a duodenal aspirate for
analysis of enzyme activity, composition, and cytology. (1)
accelerate the transit of a barium meal through the small bowel,
thereby decreasing the time and
extent of radiation associated with fluoroscopy and x-ray examination
of the intestinal tract. (1)
DOSAGE AND ADMINISTRATION
Recommended Adult Dosage and Administration by Indication:
To Stimulate Contraction of the Gallbladder
0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous
injection. If satisfactory contraction
does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30
to 60 seconds. (2.1)
_Alternatively consider an intravenous infusion to reduce
gastrointestinal adverse reactions_: 0.12
mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and
infused over 50 minutes at a rate
of 2 mL per minute. (2.1, 2.2, 5.3)
To Stimulate Pancreatic Secretion in Combination with Secretin
30 minutes after initiation of secretin for injection, administer 0.02
mcg/kg diluted in 30 mL of 0.9%
Sodium Chloride Injection USP and infused over 30 minutes at a rate of