KINEVAC

KINEVAC- sincalide injection, powder, lyophilized, for solution
Bracco Diagnostics Inc.

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 minutes

Kinevac: 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.

3 DOSAGE FORMS AND STRENGTHS

For injection: 5 mcg of sincalide as a lyophilized white powder for reconstitution in a single-dose vial.

4 CONTRAINDICATIONS

KINEVAC is contraindicated in patients with:

  • a history of hypersensitivity to sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)].
  • intestinal obstruction.

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis, Anaphylactic Shock and Other Hypersensitivity Reactions

In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of Kinevac [see Adverse Reactions (6)].

Due to the potential for anaphylaxis, appropriate medical support should be readily available when Kinevac is administered. If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. Observe patients closely during and after the infusion. Do not reinitiate Kinevac in patients who have experienced symptoms of hypersensitivity [see Contraindications (4)].

5.2 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.

5.3 Gastrointestinal Adverse Reactions with Intravenous Injection

Administration of Kinevac as an intravenous injection may cause adverse reactions such as nausea, vomiting, abdominal pain or cramping, dizziness, and flushing [see Adverse Reactions (6)]. These reactions are generally transient. To reduce the risk of adverse reactions with intravenous injection when used to simulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer Kinevac as an intravenous infusion over 50 or 30 minutes, respectively [see Dosage and Administration (2.1)].

5.4 Preterm Labor or Spontaneous Abortion

Because of Kinevac’s effect on smooth muscle, pregnant patients should be advised that spontaneous abortion or premature induction of labor may occur [see Use in Specific Populations (8.1) ].

6 ADVERSE REACTIONS

The following adverse reactions associated with the use of Kinevac were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure.

The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease.

Less common adverse reactions include:

Hypersensitivity reactions: anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortness of breath, nausea, abdominal cramping, diaphoresis, hives, rash, itching; and numbness of face, lips and eyes [see Contraindications (4), (5.1)].

Neurological reactions: seizures, headache.

Vasovagal reactions: dizziness, loss of consciousness, nausea, diaphoresis, syncope and hypotension (generally self-limiting).

Other: nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing.

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