SINCALIDE- 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:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sincalide for Injection 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. Sincalide for Injection 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 abortion [see Warnings and Precautions (5.4)]. Available data with Sincalide for Injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. However, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 Animal Data There were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (Gestation Days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. No effects on embryo-fetal development were observed in Sprague-Dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from Gestation Days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. In a separate study at a higher dose of 90 mcg/kg administered subcutaneously to CFY rats from Gestation Day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. Risk Summary There are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Sincalide for Injection and any potential adverse effect on the breastfed infant from Sincalide for Injection or from the underlying condition. The safety and effectiveness in pediatric patients have not been established. Clinical studies of Sincalide for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Product summary:

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 as follows: 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

SINCALIDE - SINCALIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SINCALIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SINCALIDE FOR INJECTION
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)
INDICATIONS AND USAGE
Sincalide for Injection 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