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)

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 1 mL per minute. (2.1, 2.2)

To Accelerate Transit of a Barium Meal Through the Small Intestine

• After the barium meal is beyond the proximal jejunum, administer 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. (2.1)
• If satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second 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 0.9% Sodium Chloride Injection USP and infused over 30 minutes. (2.1, 2.2, 5.3)

For injection: 5 mcg of sincalide as a lyophilized powder in a single-dose vial for reconstitution (3)

• History of hypersensitivity to sincalide. (4, 5.1)
• Intestinal obstruction. (4)

• Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions: May occur during or soon after administration. If symptoms occur, discontinue the drug. (4, 5.1)
• 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. (5.2)
• 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 stimulate 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. (2.1, 5.3)
• Preterm Labor or Spontaneous Abortion: Advise pregnant women of the potential risk for preterm labor and spontaneous abortion. (5.4, 8.1)

Most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drugs that Affect Gallbladder Motility or Contractile Response: May interfere with response to sincalide. Consider discontinuing these drugs prior to administration of Kinevac, when used to stimulate contraction of the gallbladder. (7.1)