Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Kinevac: 5 mcg (1 ea) [contains sodium metabisulfite]
Pharmacology
Mechanism of Action
Stimulates contraction of the gallbladder; inhibits gastric emptying by causing pyloric contraction, and increases intestinal motility; stimulates pancreatic secretion; causes smooth muscle contraction
Pharmacokinetics/Pharmacodynamics
Onset of Action
Contraction of the gallbladder: ~5 to 15 minutes
Use: Labeled Indications
Barium meal transit time acceleration: 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.
Gallbladder contraction stimulation: 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.
Pancreatic secretion stimulation: To stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology.
Contraindications
Hypersensitivity to sincalide or any component of the formulation; intestinal obstruction
Canadian labeling: Additional contraindications (not in US labeling): In patients where a fatty meal would be contraindicated, including: acute abdomen; acute pancreatitis; acute cholecystitis; appendicitis; bleeding, penetrating, or perforating peptic ulcer; common bile duct obstruction; cystic duct obstruction; gallbladder empyema or infection; hollow viscous perforation; peritonitis; pyloric stenosis; small gallbladder stones
Dosage and Administration
Dosing: Adult
Barium meal transit time acceleration:
IV: 0.04 mcg/kg over 30 to 60 seconds initiated once the barium meal is beyond the proximal jejunum; if movement of barium has not occurred in 30 minutes, a second dose of 0.04 mcg/kg may be administered
IV infusion: 0.12 mcg/kg; administered over 30 minutes
Gallbladder contraction stimulation:
IV: 0.02 mcg/kg over 30 to 60 seconds; if satisfactory contraction does not occur in 15 minutes, a second dose of 0.04 mcg/kg may be given
IV infusion: 0.12 mcg/kg; administered over 50 minutes
IM: 0.1 mcg/kg
Pancreatic secretion stimulation: IV: 0.02 mcg/kg; administered over 30 minutes; initiated 30 minutes after the start of the secretin infusion
Dosing: Geriatric
Refer to adult dosing.
Reconstitution
To reconstitute, add 5 mL of sterile water for injection to vial.
Contraction of gallbladder: Total dose of reconstituted product may be further diluted in 100 mL with sodium chloride 0.9%
Pancreatic function: Total dose of reconstituted product should be further diluted in 30 mL with sodium chloride 0.9%
Accelerate barium transit through small bowel: Total dose of reconstituted product should be further diluted in 100 mL with sodium chloride 0.9%
Administration
IV: Administration via infusion may help manage some adverse events or increase GI tolerance.
Contraction of gallbladder: Administer as an IV push over 30 to 60 seconds, or as an IV infusion mixed in 100 mL of NS at a rate of 2 mL/minute.
Pancreatic function: Administer over 30 minutes beginning 30 minutes after the initiation of secretin infusion.
Accelerate barium transit through small bowel: Administer as an IV push over 30 to 60 seconds, or as an IV infusion mixed in 100 mL NS over 30 minutes. Administer dose after the barium meal is beyond the proximal jejunum. .
Storage
Store intact vials at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Once reconstituted, store at room temperature for up to 8 hours. Discard any unused portion. If further diluted for infusion, may be kept at room temperature; use within 1 hour.
Drug Interactions
Drugs that Affect Gallbladder Function: May diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Consider therapy modification
Adverse Reactions
>10%: Gastrointestinal: Abdominal distress (≥20%), abdominal pain (≥20%), nausea (≥20%)
<1%, postmarketing, and/or case reports: Abdominal cramps, anaphylactic shock, anaphylaxis, bowel urgency, bradycardia, diaphoresis, diarrhea, dizziness, dyspnea, facial numbness, flushing, headache, hypersensitivity reaction, hypertension, hypotension, loss of consciousness, pharyngeal edema, pruritus, seizure, skin rash, sneezing, syncope, urticaria, vomiting
Warnings/Precautions
Concerns related to adverse effects:
- Gastrointestinal: IV injection may cause transient GI adverse effects (eg, nausea, vomiting, abdominal pain/cramping, dizziness, flushing). Administration via IV infusion may lessen risks of developing adverse GI effects.
- Hypersensitivity: Serious reactions, including anaphylaxis, have been reported during or within 1 hour following sincalide administration; monitor during and after infusion. Immediately discontinue therapy and initiate appropriate treatment for hypersensitivity reactions.
- Obstruction: Increased risk (minimal) of evacuating small gallstones into cystic duct or common bile duct and obstructing flow.
Concurrent drug therapy issues:
- Gallbladder response: Drugs known to stimulate or inhibit gallbladder motility or contractile response may interfere with response to sincalide. Consider temporary discontinuation of these drugs prior to sincalide administration when used for gallbladder contraction.
Dosage form specific issues:
- Sodium metabisulfite: Solution for injection contains sodium metabisulfite, which may cause allergic reactions in some individuals.
Monitoring Parameters
Hypersensitivity reaction (during and within 1 hour of administration).
Pregnancy
Pregnancy Considerations
Based on limited human data (Silberstein 1994) and its effect on smooth muscle, use during pregnancy, including near term, should be avoided (may cause spontaneous abortion or premature labor).
Patient Education
What is this drug used for?
- It is used with a special imaging test.
Frequently reported side effects of this drug
- Abdominal pain
- Nausea
- Vomiting
- Abdominal cramps
- Flushing
- Diarrhea
- Sneezing
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe headache
- Dizziness
- Passing out
- Vision changes
- Slow heartbeat
- Shortness of breath
- Sweating a lot
- Numbness or tingling of the face
- Seizures
- Feeling of needing to have a bowel movement often
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
