Secretin human
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Secretin human is an endocrine-metabolic agent that is FDA approved for the treatment of stimulation of pancreatic secretions to aid in the diagnosis of exocrine pancreas dysfunction, simulation of gastrin secretion to aid in the diagnosis of gastrinoma, facilitation of identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP). Common adverse reactions include nausea, flushing, abdominal pain, and vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Stimulation of pancreatic secretions, including bicarbonate to aid in the diagnosis of exocrine pancreas dysfunction
- Dosage: 0.2 mcg/kg body weight by intravenous injection over 1 minute.
Gastroduodenal (Dreiling) Tube Collection Method
A radiopaque, double-lumen tube is passed through the mouth following a 12-15 hour fast. Under fluoroscopic control, the opening of the proximal lumen of the tube is placed in the gastric antrum and the opening of the distal lumen just beyond the papilla of Vater. The positioning of the tube must be confirmed and the tube secured prior to synthetic human secretin testing. Intermittent negative pressure of 25-40 mmHg is applied to both lumens and maintained throughout the test. When duodenal contents have a pH of ≥ 6, a baseline sample of duodenal fluids is collected for a 10 minute period. A test dose of secretin human 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, secretin human at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. Duodenal fluid is collected for 60 minutes thereafter. The aspirate is divided into four collection periods of fifteen minutes each. The duodenal lumen of the tube is cleared with an injection of air after collection of each sample. Wide variation in volume of the aspirate is indicative of incomplete aspiration. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L.
Endoscopic Collection Method: Endoscopic Pancreatic Function Test (ePFT)
After assessment of patients for sedation and analgesia, a test dose of secretin human 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, ChiRhoStim® at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. An upper endoscopy is performed with conscious sedation, after topical anesthetic. All gastric fluid is aspirated through the endoscope and discarded. After small bowel intubation to the junction of the second and third portion of the duodenum, fluid is aspirated for 1 to 3 minutes and collected in 5 separate specimen traps at baseline (0), 15, 30, 45, and 60 minutes after secretin injection. The patients remain intubated with the upper endoscope for one hour in the left lateral decubitus position. Boluses of meperidine and midazolam in a 25:1 mg ratio are administered to maintain analgesia and sedation during the 1-hour procedure. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L.
Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma
- Dosage: 0.4 mcg/kg body weight by intravenous injection over 1 minute.
- The patient should fast for at least 12 hours prior to beginning the test. Prior to injection of ChiRhoStim®, two blood samples are drawn for determination of fasting serum gastrin levels (baseline values). Subsequently, a test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, ChiRhoStim® at a dose of 0.4 mcg/kg of body weight is injected intravenously over 1 minute; post-injection blood samples are collected after 1, 2, 5, 10, and 30 minutes for determination of serum gastrin concentrations.
- Gastrinoma is strongly indicated in patients who show an increase in serum gastrin concentrations of 110 pg/mL over basal level on any of the post injection samples.
Facilitation of identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP)
- Dosage: 0.2 mcg/kg body weight by intravenous injection over 1 minute.
- Administration of ChiRhoStim® may be given when difficulty is encountered by the endoscopist in identifying the ampulla of Vater for various reasons including: anatomic deformity secondary to prior surgery, radiation therapy, peptic ulcer disease, tumors, etc. or in identifying the accessory papilla in patients with pancreas divisum. A test dose of ChiRhoStim® 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, a dose of 0.2 mcg/kg of body weight intravenously over 1 minute may be administered and will result in visible excretion of pancreatic fluid from the orifices of these papillae enabling their identification and facilitating their cannulation.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secretin human in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secretin human in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Secretin human FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secretin human in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secretin human in pediatric patients.
Contraindications
There is limited information regarding Secretin human Contraindications in the drug label.
Warnings
There is limited information regarding Secretin human Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Secretin human Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Secretin human Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Secretin human Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Secretin human in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Secretin human in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Secretin human during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Secretin human in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Secretin human in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Secretin human in geriatric settings.
Gender
There is no FDA guidance on the use of Secretin human with respect to specific gender populations.
Race
There is no FDA guidance on the use of Secretin human with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Secretin human in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Secretin human in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Secretin human in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Secretin human in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Secretin human Administration in the drug label.
Monitoring
There is limited information regarding Secretin human Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Secretin human and IV administrations.
Overdosage
There is limited information regarding Secretin human overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Secretin human Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Secretin human Mechanism of Action in the drug label.
Structure
There is limited information regarding Secretin human Structure in the drug label.
Pharmacodynamics
There is limited information regarding Secretin human Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Secretin human Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Secretin human Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Secretin human Clinical Studies in the drug label.
How Supplied
There is limited information regarding Secretin human How Supplied in the drug label.
Storage
There is limited information regarding Secretin human Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Secretin human Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Secretin human interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Secretin human Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Secretin human Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.