Sincalide

For Injection, 5 mcg

Its main use is to stimulate gallbladder contraction during diagnostic imaging examinations such as a HIDA scan. Sincalide has been shown to provide a more reliable measurement of Gall Bladder Ejection Fraction (GBEF) than a fatty meal because its effect is more consistent and predictable. ^1,2

Sincalide for Injection is supplied as 5 mcg of Sincalide as a lyophilized powder for reconstitution in a single-dose vial.

NDC 72266-248-05 Packages of 5 vials

Preservative free
Polysorbate free
Container closure is not made with natural rubber latex

Only FDA Approved Sincalide Product with 24 Months Shelf Life

	Fosun Pharma USA Sincalide for Injection	Kinevac®
Regulatory	FDA Approved	FDA Approved
Indications	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. stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. 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 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. stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. 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.
Strength	5 mcg per vial	5 mcg per vial
Packaging	Single-Dose Vials 5 Vials per pack	Single-Dose Vials 10 Vials per pack
Dosing & Administration	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.	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.
Inactive Ingredients	30 mg arginine hydrochloride 15 mg lysine hydrochloride 170 mg mannitol 4 mg methionine 2 mg pentetic acid 0.04 mg sodium metabisulfite	30 mg arginine hydrochloride 15 mg lysine hydrochloride 170 mg mannitol 4 mg methionine 2 mg pentetic acid 0.04 mg sodium metabisulfite 9 mg potassium phosphate dibasic 0.005 mcg polysorbate 20
Reconstituted Storage	IV Injection: Store the reconstituted solution at room temperature. Discard after 8 hours. IV Infusion: Store the reconstituted solution at room temperature. Discard after 1 hour.	IV Injection: Store the reconstituted solution at room temperature. Discard after 8 hours. IV Infusion: Store the reconstituted solution at room temperature. Discard after 1 hour.
Vial Storage	Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].	Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Sincalide for Injection is contraindicated in patients hypersensitive to Sincalide and in patients with intestinal obstruction. Due to Sincalide’s effect on smooth muscle, pregnant patients should be advised that spontaneous abortion or premature induction of labor may occur. Adverse reactions to Sincalide are generally mild and of short duration. The most frequent adverse reactions were abdominal discomfort or pain, and nausea.

References

1. Ziessman, Harvey A., Sincalide: A Review of Clinical Utility, Proper Infusion Methodology, and Alternative Cholecystogogues. Journal of Nuclear Medicine Technology, September 2019, 47 (3) 210-212.

2. Fotos, Joseph S., Tulchinsky, Mark, Oral Cholecystagogue Cholescintigraphy, A Systemic Review of Fatty Meal Options. Clinical Nuclear Medicine, October 2015, 40 (10): p 796-798.

Note

Kinevac is a registered trademark of Bracco Diagnostics Inc.

Prescribing information

Important safety information

Indications

Sincalide for Injection is a cholecystokinin (CCK) analog indicated in adults to:

Stimulate gallbladder contraction, as may be necessary 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.
Stimulate pancreatic secretin in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology.
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.

Important safety information

Warnings and precautions

Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions: May occur during or soon after administration. If symptoms occur, discontinue the drug.
Evacuation of Gallstones: Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct.
Gastrointestinal Adverse Reactions with Intravenous Injection: Administration as an intravenous injection may cause transient nausea, vomiting, abdominal pain or cramping, dizziness or flushing. To reduce the risk of adverse reactions when used to simulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer as an intravenous infusion over 50 or 30 minutes, respectively.
Preterm Labor or Spontaneous Abortion: Advise pregnant women of the potential risk for preterm labor and spontaneous abortion.

Adverse reactions

Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea.

Drug interactions

Drugs that Affect Gallbladder Motility or Contractile Response: May interfere with response to Sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to stimulate contraction of the gallbladder.

Please see Full Prescribing Information