KINEVAC Powder for solution for injection Ref.[10405] Active ingredients: Sincalide

Source: FDA, National Drug Code (US) Revision Year: 2018

1. Indications and Usage

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.

2. Dosage and Administration

2.1 Recommended Dosage and Administration Instructions

The recommended dosage and administration of Kinevac by indication is shown in Table 1. For preparation instructions see Dosage and Administration (2.2).

Table 1. Recommended Adult Dosage and Administration of Kinevac by Treatment Indication:

Indication	Recommended Adult Dosage and Administration of KINEVAC
To stimulate contraction of the gallbladder	Kinevac 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. Alternatively, Consider an Intravenous Infusion to Reduce Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.3)]: 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.
To stimulate pancreatic secretion in combination with secretin for injection	Secretin for Injection: 0.25 units/kg as intravenous infusion over 60 minutesKinevac: 30 minutes after initiation of secretin infusion, administer Kinevac 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.
To accelerate the transit of a barium meal through the small intestine	After the barium meal is beyond the proximal jejunum, administer Kinevac 0.04 mcg/kg over 30 to 60 seconds via intravenous injection.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. Alternatively, Consider an Intravenous Infusion to Reduce Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.3)]: 0.12 mcg/kg diluted in 100 mL 0.9% Sodium Chloride Injection USP and infused over 30 minutes.

2.2 Preparation Instructions

For Intravenous Injection:

Reconstitute Kinevac aseptically by adding 5 mL of Sterile Water for Injection USP to the vial.
Inspect the reconstituted solution visually for particulate matter and discoloration after reconstitution and prior to administration.
Withdraw the prescribed dose of the reconstituted solution from the vial and administer as an intravenous injection over 30 to 60 seconds, as shown in Table 1. Discard the unused portion.
Store the reconstituted solution at room temperature. Discard after 8 hours.
For single use only; discard unused portion.

For Intravenous Infusion:

Reconstitute Kinevac aseptically by adding 5 mL of Sterile Water for Injection USP to the vial.
After reconstitution, withdraw the prescribed dose of the solution from the vial. Discard unused portion.
Dilute the reconstituted solution in 30 mL or 100 mL of 0.9% Sodium Chloride Injection USP, depending on the indication, as described in Table 1.
Inspect the Kinevac solutions visually for particulate matter and discoloration after reconstitution, dilution and prior to administration.
Store the diluted solution at room temperature.

Discard after 1 hour

10. Overdosage

In the event of an overdose, symptoms related to vagal stimulation, such as gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea), hypotension with dizziness or fainting may occur. Overdosage symptoms should be treated symptomatically and should be of short duration.

A single bolus intravenous injection of 0.05 mcg/kg (approximately 2 to 3 times the human dose of 0.02 mcg/kg), sincalide caused hypotension and bradycardia in dogs. In addition, higher doses injected intravenously once or repeatedly in dogs caused syncope and ECG changes (approximately 5 times the human dose of 0.02 mcg/kg). These effects were attributed to sincalide-induced vagal stimulation in that all were prevented by pretreatment with atropine or bilateral vagotomy.

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

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