pharmacopeia
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Mechanism of action

Sourced from openFDA

12.1 Mechanism of Action The primary action of ChiRhoStim ® is to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate. Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids and amino acids.

Secretin Receptor

Indications

Sourced from openFDA
  • ChiRhoStim ® is indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction. gastrin secretion to aid in the diagnosis of gastrinoma, and pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).

Contraindications

Sourced from openFDA
  • None.contraindicated

Dosage & administration

Sourced from openFDA

2.2 Preparation and Dosage Regimen The recommended dosage regimen of ChiRhoStim® by indication is shown below in Table 1. TABLE 1: Dosage by Indication Indication Recommended Dosage Regimen Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction 0.2 mcg/kg by intravenous injection over 1 minute Stimulation of gastrin secretion to aid in diagnosis of gastrinoma 0.4 mcg/kg by intravenous injection over 1 minute Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) 0.2 mcg/kg by intravenous injection over 1 minute Preparation of Recommended Dosage ChiRhoStim ® is a lyophilized powder, which requires reconstitution prior to intravenous administration. Determine the number of vials needed for the prescribed dosage based on the patient’s weight and recommended dosage. Follow these steps to determine the patient dose: Total dose (mcg) = patient’s weight (kg) x prescribed dose (mcg/kg). Total injection volume (mL) = total dose (mcg) divided by the concentration of the reconstituted solution (2 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). To reconstitute one 16 mcg vial: Dissolve the contents of the ChiRhoStim ® 16 mcg vial in 8 mL of 0.9% Sodium Chloride Injection, USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution.

Warnings & precautions

Sourced from openFDA

Patients with alcoholic or other liver disease may be hyperresponsive to stimulation with ChiRhoStim®, masking the presence of coexisting pancreatic disease. Consider additional testing and clinical assessments for aid in diagnosis. ​​ Hyporesponse to Secretin Stimulation Testing in Patients with Vagotomy, Inflammatory Bowel Disease or Receiving Anticholinergics : Discontinue anticholinergic drugs at least 5 half-lives prior to stimulation testing; consider additional testing and clinical assessments for aid in diagnosis. (2.1, 5.1, 7.1) Hyperresponse to Secretin Stimulation Testing : Increased gastrin secretion in patients receiving H 2 -receptor antagonists or PPIs falsely suggesting gastrinoma; discontinue co-administered drug prior to stimulation testing. Increased pancreatic secretions in patients with alcoholic or other liver disease masking coexisting pancreatic disease; consider additional testing and clinical assessments for aid in diagnosis. (2.1, 5.2, 7.2)

Adverse reactions

Sourced from openFDA

6.1 Clinical Trials Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed during the clinical trials of a drug cannot always be directly compared to the rates observed during the clinical trials of another drug and may not reflect the adverse reaction rates observed in practice. The data described below reflect exposure to ChiRhoStim® in 531 patients from an open-label clinical trial. The population consisted of patients aged 1 to 91 years, 185 males, 346 females, 480 Caucasians, 31 Blacks, 12 American Indians, 6 Hispanics, and 2 Asians with known or suspected diseases of the exocrine pancreas including chronic pancreatitis and pancreatic cancer. Most patients received a single dose of ChiRhoStim® in a dose range of 0.2 mcg/kg to 0.4 mcg/kg. The most common adverse reactions (reported in at least 2 patients in the trial) are listed in Table 2. TABLE 2 Adverse Reactions in at Least 2 Patients Treated with a Single-Dose of ChiRhoStim® in a Clinical Trial Adverse Reaction ChiRhoStim® Number of Patients N = 531 Nausea 9 Vomiting 3 Flushing 2 Upset stomach 2 Most common adverse reactions (≥2 patients) are nausea, vomiting, flushing, and upset stomach. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact ChiRhoClin, Inc. at 1-877-272-4888 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: 07/2017

Use in specific populations

Sourced from openFDA

Pregnancy Risk Summary There are no available data (either clinical studies or postmarketing reports) of use of synthetic human secretin in pregnant women. Animal reproduction studies have not been conducted with synthetic human secretin. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of synthetic human secretin in human or animal milk, the effects of synthetic human secretin on the breastfed infant, or the effects of synthetic human secretin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ChiRhoStim ® and any potential adverse effects on the breastfed infant from ChiRhoStim ® or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of ChiRhoStim ® in pediatric patients have not been established. 8.5 Geriatric Use Among the 531 patients who have received ChiRhoStim ® in a clinical trial, 11% were 65 years of age or older and 5% were 75 years of age or older.

Pharmacokinetics

Sourced from openFDA
Metabolism
12.3 Pharmacokinetics The pharmacokinetic profile for synthetic human secretin was evaluated in 12 healthy subjects following a single-dose of human secretin administered as a 0.4 mcg/kg intravenous bolus. The plasma concentrations of human secretin declined to baseline concentrations within 90 to 120 minutes.

Approval history

Sourced from openFDA
  • Apr 9, 2004NDANDA021256Chirhoclin

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Muscle Spasms150%
  2. 2Product Storage Error150%

Literature

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Recent PubMed references pinned to Secretin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 52 ClinicalTrials.gov registrations naming Secretin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Secretin work?
12.1 Mechanism of Action The primary action of ChiRhoStim ® is to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate. Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids and amino acids.
What is Secretin used for?
According to FDA labeling, Secretin carries indications including: ChiRhoStim ® is indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction. gastrin secretion to aid in the diagnosis of gastrinoma, and pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Secretin?
Secretin is classified as Tests for pancreatic function, Secretin-class Hormone, Secretin Receptor Agonists, Stimulation Pancreatic Fluid/Electrolyte Secretion.
What are the contraindications for Secretin?
Secretin labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
Note. Data for secretin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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