Kinevac (sincalide) dosing, indications, interactions, adverse effects, and more

Sections

Sections sincalide
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Administration
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for reconstitution

5mcg/vial

Gallbladder Contraction

Indicated 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

0.02 mcg/kg IV injected over 30-60 seconds; if satisfactory contraction of the gallbladder does not occur in 15 minutes, a second dose may be administered

When used in cholecystography, roentgenograms are usually taken at 5-minute intervals after the injection

For visualization of the cystic duct, it may be necessary to take roentgenograms at 1-minute intervals during the first 5 minutes after the injection

Alternant administration to reduce intestinal side effects

0.12 mcg/kg in 100 mL NaCl as an IV infusion at rate of 2 mL/minute, OR
0.1 mcg/kg IM

Pancreatic Secretion

Indicated to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology

Secretin dose: 0.25 units/kg IV infusion over 60 minutes, THEN

Sincalide dose: 30 minutes after the initiation of the secretin infusion, a separate IV infusion of sincalide of 0.02 mcg/kg is administered over a 30-minute interval; further dilute calculated dose with sodium chloride for injection to total 30 mL; infuse IV at rate of 1 mL/minute

Barium Transit

Indicated 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

Administer sincalide after the barium meal is beyond the proximal jejunum 0.04 mcg/kg IV injected over 30-60 seconds; if satisfactory transit of the barium meal has not occurred in 30 minutes, a second dose may be administered.

Alternant administration to reduce intestinal side effects: 0.12 mcg/kg diluted in 100 mL NaCl infused IV over 30 minutes

Safety and efficacy not established

>10%

Abdominal discomfort or pain (20%)

Nausea (20%)

1-10%

Dizziness (2%)

<1%

Vomiting

Flushing

Sweating

Rash

Hypotension

Hypertension

Shortness of breath

Urge to defecate

Headache

Diarrhea

Sneezing

Numbness

Contraindications

Hypersensitivity

Intestinal obstruction

Cautions

Stimulating gallbladder contraction in patients with small gallbladder stones could result in stones lodging in the cystic duct or the common bile duct

Anaphylactic shock and other serious hypersensitivity reactions reported during and within one hour following administration; due to potential for anaphylaxis, appropriate medical support should be readily available when therapy administered; if anaphylaxis or other hypersensitivity reactions occur, immediately discontinue infusion and initiate appropriate medical treatment; observe patients closely during and after infusion; do not reinitiate therapy in patients who have experienced symptoms of hypersensitivity

Stimulates smooth muscle contraction; risk of uterine stimulation (see Pregnancy & Lactation)

Pregnancy

Based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion; 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

Animal data

In animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during period of organogenesis, no effects were seen at doses comparable to maximum recommended clinical dose on a mg/kg basis; however, in a prenatal development study in which rats were administered the drug 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

Lactation

There are no data regarding presence of drug in human or animal milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effect on breastfed infant from drug or from underlying condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Cholecystopancreatic-gastrointestinal hormone peptide; produces a substantial reduction in gallbladder size by causing this organ to contract; evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin

Like cholecystokinin, sincalide stimulates pancreatic secretion; concurrent administration with secretin increases both the volume of pancreatic secretion and the out-put of bicarbonate and protein (enzymes) by the pancreas

This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate; parameters usually determined are: volume of the secretion; bicarbonate concentration; and amylase content (which parallels the content of trypsin and total protein)

Both cholecystokinin and sincalide stimulate intestinal motility, and may cause pyloric contraction which retards gastric emptying

Absorption

Time to maximal effect: 5-15 minutes

IV Preparation

Reconstitute lyophilized powder by adding 5 mL of sterile water for injection per 5 mcg vial

IV Administration

Varies for specific indication, see Adult Dosing

Storage

Unreconstituted vial: Store at controlled room temperature (25° C [77° F]); excursions permitted to 15-30° C (59-86° F)

Reconstituted vial: May store at room temperature; use within 8 hr of reconstitution

BRAND	FORM.	UNIT PRICE	PILL IMAGE
Kinevac injection -	5 mcg vial

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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