ChiRhoStim

Diagnostic Hormonal Agents

Secretin stimulation testing with synthetic secretin should only be performed by physicians with sufficient expertise.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

Calculate number of vials needed for dose:
Total dose (mcg) = patient's weight (kg) x prescribed dose (mcg/kg).
Total injection volume (mL) = total dose (mcg) divided by concentration of the reconstituted solution (2 mcg/mL or 4 mcg/mL).
Round the total injection volume to the nearest tenth of a mL.
Total number of vials = total injection volume divided by the vial volume (8 mL or 10 mL).
 
Reconstitution of powder for injection:
16 mcg vial (synthetic human and porcine secretin): Dissolve the contents of the vial in 8 mL of 0.9% Sodium Chloride Injection to yield a concentration of 2 mcg/mL.
40 mcg vial (synthetic human secretin): Dissolve the contents of the vial in 10 mL of 0.9% Sodium Chloride Injection to yield a concentration of 4 mcg/mL.
Once reconstituted, shake vigorously to ensure dissolution.
Repeat above steps to reconstitute additional vials, as needed, to administer the total dose.
Storage: Use immediately after reconstitution. Discard any unused portion.
 
IV bolus:
Test dose (synthetic porcine secretin): If using porcine secretin, a 0.2 mcg (0.1 mL) test dose is required before administration of the full dose. Withdraw 0.1 mL from vial and inject as test dose. Monitor patient for an acute hypersensitivity reaction for at least 1 minute. If no hypersensitivity reaction occurs, administer the full dose.
Withdraw the calculated volume of reconstituted solution from the required number of vials.
Administer IV over 1 minute.
 
Stimulation of pancreatic secretion, including bicarbonate, to aid in diagnosis of exocrine pancreas dysfunction:
Instruct patient to fast for at least 12 to 15 hours prior to beginning test.
Collect samples using either the gastroduodenal (fluoroscopic) or endoscopic collection method.
Gastroduodenal (Dreiling) tube collection method:
Place a radiopaque, double-lumen gastroduodenal tube under fluoroscopic guidance, with the opening of the proximal lumen in the gastric antrum and the opening of the distal lumen beyond the ampulla of Vater.
Connect both lumens to low intermittent suction, and apply negative pressure of 25 to 40 mmHg to both lumens.
Collect a sample of duodenal contents and check pH of the aspirate to verify tube position. Proceed to next step if aspirate has a pH of 6 or higher. If pH is less than 6, reposition tube.
Collect a baseline sample of duodenal fluid for a 15-minute period.
For 60 minutes after drug administration, collect 4 consecutive 15-minute samples of duodenal fluid. Clear the duodenal lumen of the tube with an injection of air after each 15-minute sample collection. Of note, wide variation in aspirate volumes is indicative of incomplete aspiration between samples.
Endoscopic collection method (endoscopic pancreatic function test):
With patient in the left lateral decubitus position, perform a standard upper endoscopy by passing the endoscope into the stomach.
After gastric insufflation, aspirate all gastric fluid through the endoscope and discard.
Pass endoscope through the pylorus into small intestine and position the tip of the endoscope at the junction of the second and third portion of the duodenum.
Aspirate duodenal fluid for several seconds to clear the residual gastric acid from the tube.
Collect baseline aspirate of duodenal fluid (3 to 5 mL) from the post-bulbar duodenum.
Starting 15 minutes after secretin administration, collect 4 timed duodenal fluid aspirates (each 3 to 5 mL) at 15-minute intervals. Keep patient in the left lateral decubitus position throughout the procedure.
Place fluid specimens on ice for immediate measurement of bicarbonate concentrations. If samples will not be analyzed immediately, store fluid at -80 degrees C.
Peak bicarbonate concentrations of 80 to 130 mEq/L after secretin administration indicate normal pancreatic exocrine function. A peak bicarbonate concentration 80 mEq/L or less for any sample indicates exocrine pancreatic dysfunction typically associated with chronic pancreatitis.
 
Stimulation of gastrin secretion to aid in diagnosis of gastrinoma:
Instruct patients to fast for at least 12 hours prior to beginning test.
Take 2 baseline blood samples for determination of fasting serum gastrin concentrations.
Collect post-injection blood samples after 1, 2, 5, 10, and 30 minutes for determination of serum gastrin concentrations.
Gastrinoma is strongly suspected in patients who show an increase in serum gastrin concentration of more than 110 picograms/mL over baseline concentrations on any of the post-injection samples.
 
Stimulation of pancreatic secretions to facilitate identifying the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP):
Visible excretion of pancreatic fluid from orifices of these papillae aids in their identification and facilitates cannulation.
 
Intermittent IV infusion:
Administer IV over 60 minutes. Start sincalide 30 minutes after the start of the secretin infusion.

bradycardia / Rapid / 2.0-2.0

hypotension / Rapid / 2.0-2.0

nausea / Early / 1.7-7.0
flushing / Rapid / 0.4-4.0
diaphoresis / Early / 3.0-3.0
vomiting / Early / 0.5-0.6

ChiRhoStim

Rx

Synthetic human or porcine secretin
Used for diagnosis of pancreas dysfunction or gastrinoma and for identifying the ampulla of Vater and accessory papilla during ERCP
Amino acid sequences identical to naturally occurring human secretin

0.4 mcg/kg IV over 1 minute. The patient should be fasting for at least 12 hours prior to the test. If using porcine secretin, a 0.2 mcg (0.1 mL) test dose is required before administration of the full dose.

0.2 mcg/kg IV over 1 minute as a single dose.

0.2 mcg IV test dose, then 0.2 mcg/kg IV over 1 minute as a single dose.

0.25 units/kg IV over 60 minutes as a single dose. Start sincalide 30 minutes after the start of the secretin infusion.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Amoxicillin; Clarithromycin; Omeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Anticholinergics: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Aspirin, ASA; Omeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Atropine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Atropine; Difenoxin: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Belladonna; Opium: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Benztropine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Budesonide; Glycopyrrolate; Formoterol: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Chlordiazepoxide; Clidinium: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Cimetidine: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Dexlansoprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Dicyclomine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Diphenoxylate; Atropine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Esomeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Famotidine: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Flavoxate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Glycopyrrolate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Glycopyrrolate; Formoterol: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
H2-blockers: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Homatropine; Hydrocodone: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Hyoscyamine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Ibuprofen; Famotidine: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Indacaterol; Glycopyrrolate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Lansoprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Lansoprazole; Amoxicillin; Clarithromycin: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Methenamine; Sodium Acid Phosphate; Methylene Blue; Hyoscyamine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Methscopolamine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Naproxen; Esomeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Neostigmine; Glycopyrrolate: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Nizatidine: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Omeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Omeprazole; Amoxicillin; Rifabutin: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Omeprazole; Sodium Bicarbonate: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Oxybutynin: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Pantoprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Propantheline: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Proton pump inhibitors: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Rabeprazole: (Major) Discontinue use of proton pump inhibitors before administering secretin. Patients who are receiving proton pump inhibitors at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. The time required for serum gastrin concentrations to return to baseline after discontinuation of a proton pump inhibitor is specific to the individual drug.
Ranitidine: (Major) Discontinue use of H2-blockers at least 2 days before administering secretin. Patients who are receiving H2-blockers at the time of stimulation testing may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma.
Scopolamine: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Sincalide: (Moderate) Sincalide-induced gallbladder ejection fraction may be affected by concurrent secretin. False study results are possible in patients with drug-induced hyper- or hypo-responsiveness; thorough patient history is important in the interpretation of procedure results.
Trihexyphenidyl: (Major) Discontinue anticholinergic medications at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.
Trospium: (Major) Discontinue anticholinergic medications, including trospium, at least 5 half-lives before administering secretin. Patients who are receiving anticholinergics at the time of stimulation testing may be hyporesponsive to secretin stimulation and produce a false result. Consider additional testing and clinical assessments for aid in diagnosis.

ChiRhoStim Intravenous Inj Pwd F/Sol: 16mcg

0.4 mcg/kg/dose IV.

0.4 mcg/kg/dose IV.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Synthetic secretin is a pure peptide hormone with an amino acid sequence identical to naturally occurring secretin. The primary action of secretin is to increase the volume and bicarbonate content of secreted pancreatic fluids. Secretin is a hormone that is normally released from enterochromaffin cells in the duodenal mucosa upon exposure of the proximal intestinal lumen to gastric acid, fatty acids, and amino acids. Secretin receptors are located in the pancreas, stomach, liver, colon, brain, and other tissues. When secretin binds to secretin receptors on pancreatic duct cells, cystic fibrosis transmembrane conductance regulator (CFTR) channels are opened, which leads to secretion of bicarbonate-rich pancreatic fluid. Secretin may also work through vagal-vagal neural pathways since stimulation of the efferent vagus nerve causes bicarbonate secretion and atropine blocks secretin-stimulated pancreatic secretion.
 
The injection of exogenous secretin into patients with gastrinomas results in a rise of gastrin serum concentrations, thus aiding in the diagnosis of patients with gastrinomas (i.e., Zollinger-Ellison syndrome). The exact mechanism for this effect is not completely understood. However, research has suggested that secretin acts directly on gastrinoma cells to stimulate gastrin secretion via adenylate cyclase activation, most likely via guanine nucleotide-binding proteins.

Synthetic secretin is administered intravenously.
 
Synthetic secretin has a 2 to 2.7 L volume of distribution. The elimination half-lives for synthetic human and porcine secretin are 45 and 27 minutes, respectively. The clearance of synthetic human secretin is 580.9 +/- 51.3 mL/minute, and the clearance of porcine secretin is 487 +/- 136 mL/minute.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

After administering synthetic secretin IV bolus doses of 0.4 mcg/kg to 12 healthy volunteers, serum secretin concentrations rapidly declined to baseline concentrations within 90 to 120 minutes for human secretin and 60 to 90 minutes for porcine secretin.

There are no available data on synthetic secretin use in pregnant women. Animal reproduction studies have not been conducted with synthetic secretin. It is not known whether synthetic secretin can cause fetal harm or affect reproductive capacity when administered to a pregnant woman. Synthetic secretin should be given during pregnancy only if clearly needed.

There are no data on the presence of synthetic secretin in human milk or the effects on the breast-fed infant or milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for synthetic secretin and any potential adverse effects on the breast-fed infant from synthetic secretin or the underlying maternal condition.