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KINEVAC

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Overview

What is KINEVAC?

Kinevac (Sincalide for Injection) is a cholecystopancreatic-gastrointestinal hormone peptide for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin. Each vial of sincalide provides a sterile nonpyrogenic lyophillized white powder consisting of 5 mcg sincalide with 170 mg mannitol, 30 mg arginine hydrochloride, 15 mg lysine hydrochloride, 9 mg potassium phosphate dibasic, 4 mg methionine, 2 mg pentetic acid, 0.04 mg sodium metabisulfite, and 0.005 mcg polysorbate 20. The pH is adjusted to 6.0 - 8.0 with hydrochloric acid and/or sodium hydroxide prior to lyophilization. Sincalide is designated chemically as L-α-aspartyl-O-sulfo-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl- L-α-aspartyl-L-phenylalaninamide. Graphic formula:



What does KINEVAC look like?



What are the available doses of KINEVAC?

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What should I talk to my health care provider before I take KINEVAC?

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How should I use KINEVAC?

Kinevac (Sincalide for Injection) may be used: (1) 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; (2) to stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; (3) 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.


What interacts with KINEVAC?


  • The preparation is contraindicated in patients with:

    • a history of hypersensitivity to sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock (see , ).
    • intestinal obstruction.



What are the warnings of KINEVAC?

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 ).

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 ).

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 ).


What are the precautions of KINEVAC?

General

The possibility exists that 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. The risk of such an event is considered to be minimal because sincalide, when given as directed, does not ordinarily cause complete contraction of the gallbladder.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Teratogenic Effects

Reproduction studies in rats in which sincalide was administered subcutaneously at doses up to 12.5 times the maximum recommended human dose revealed no evidence of harm to the fetus due to sincalide. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed (see ).

Labor and Delivery

Sincalide should not be administered to pregnant women near term because of its effect on smooth muscle; the possibility of inducing labor prematurely exists. The effects of sincalide on labor, delivery and lactation in animals has not been determined (see ).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sincalide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.


What are the side effects of KINEVAC?

The following adverse reactions associated with the use of sincalide 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.

Reactions to sincalide are generally mild and of short duration. The most frequent adverse reactions were abdominal discomfort or pain, and nausea; rapid intravenous injection of 0.04 mcg sincalide per kg expectably causes transient abdominal cramping. These phenomena are usually manifestations of the physiologic action of the drug, including delayed gastric emptying and increased intestinal motility. These reactions occurred in approximately 20 percent of patients; they are not to be construed as necessarily indicating an abnormality of the billiary tract unless there is other clinical or radiologic evidence of disease.

Less common adverse reactions include:

Hypersensitivity reactions

Other


What should I look out for while using KINEVAC?

The preparation is contraindicated in patients with:


What might happen if I take too much KINEVAC?

Although no overdosage reports have been received, gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea) would be expected. Hypotension with dizziness or fainting might also occur. Overdosage symptoms should be treated symptomatically and should be of short duration. Starting with single bolus i.v. injection comparable to the human does of 0.4 mg/kg, sincalide caused hypotension and bradycardia in dogs. Higher doses injected once or repeatedly in dogs caused syncope and ECG changes in addition. These effects were attributed to sincalide-induced vagal stimulation in that all were prevented by pretreatment with atropine or bilateral vagotomy.


How should I store and handle KINEVAC?

Store between 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].Kinevac (Sincalide for Injection) is supplied in packages of 10 vials containing 5 mcg of sincalide per vial (NDC 0270-0556-15).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

When injected intravenously, sincalide produces a substantial reduction in gallbladder size by causing this organ to contract. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin. The intravenous (bolus) administration of sincalide causes a prompt contraction of the gallbladder that becomes maximal in 5 to 15 minutes, as compared with the stimulus of a fatty meal which causes a progressive contraction that becomes maximal after approximately 40 minutes. Generally, a 40 percent reduction in radiographic area of the gallbladder is considered satisfactory contraction, although some patients will show area reduction of 60 to 70 percent.

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 gland. This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate. The 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.

Non-Clinical Toxicology
The preparation is contraindicated in patients with:

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium Tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and action of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.

The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.









The possibility exists that 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. The risk of such an event is considered to be minimal because sincalide, when given as directed, does not ordinarily cause complete contraction of the gallbladder.

The following adverse reactions associated with the use of sincalide 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.

Reactions to sincalide are generally mild and of short duration. The most frequent adverse reactions were abdominal discomfort or pain, and nausea; rapid intravenous injection of 0.04 mcg sincalide per kg expectably causes transient abdominal cramping. These phenomena are usually manifestations of the physiologic action of the drug, including delayed gastric emptying and increased intestinal motility. These reactions occurred in approximately 20 percent of patients; they are not to be construed as necessarily indicating an abnormality of the billiary tract unless there is other clinical or radiologic evidence of disease.

Less common adverse reactions include:

Hypersensitivity reactions

Other

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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