Chirhostim Drug Information
Generic name: HUMAN SECRETIN
Uses of Chirhostim
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). ChiRhoStim® is a secretin class hormone indicated for stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction gastrin secretion to aid in the diagnosis of gastrinoma pancreatic secretions to facilitate the identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP)
Dosage & Administration of Chirhostim
| 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 |
Side Effects of Chirhostim
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. 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
Warnings & Cautions for Chirhostim
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. 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.
Drug Interactions with Chirhostim
Hyporesponse with Anticholinergics
The concomitant use anticholinergic drugs may cause a hyporesponse to stimulation testing with ChiRhoStim ®. Discontinue anticholinergic drugs at least 5 half-lives before administering ChiRhoStim ® .
Hyperresponse of Gastrin Secretion with H 2 -Receptor Antagonists and
PPIs The concomitant use of H 2 -receptor antagonists or PPIs may cause a hyperresponse in gastrin secretion in response to stimulation testing with ChiRhoStim ®, falsely suggesting gastrinoma. Discontinue H 2 -receptor antagonists at least 2 days before administering ChiRhoStim ® to aid in the diagnosis of gastrinoma. The time it takes for serum gastrin concentrations to return to baseline following discontinuation of PPIs is specific to the individual drug.
Consult the prescribing information of each specific PPI before administering ChiRhoStim ® to aid in the diagnosis of gastrinoma.
Pregnancy Safety for Chirhostim
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.
Pediatric Use of Chirhostim
Pediatric Use The safety and effectiveness of ChiRhoStim ® in pediatric patients have not been established.
Clinical Studies of Chirhostim
Stimulation of Pancreatic Secretions, Including Bicarbonate to Aid in the Diagnosis of
Exocrine Pancreas Dysfunction ChiRhoStim® administered intravenously stimulates the exocrine pancreas to secrete pancreatic juice, which can assist in the diagnosis of exocrine pancreas dysfunction. Normal ranges for pancreatic secretory response to intravenous secretin in patients with defined pancreatic disease have been shown to vary. One source of variation is related to the inter-investigator differences in operative technique.
In two studies, a total of 18 patients with a documented history of chronic pancreatitis were given 0.2 mcg/kg synthetic human secretin (sHS), 0.2 mcg/kg synthetic porcine secretin (sPS), and 1 CU/kg (equal to 0.2 mcg/kg for biologically derived secretin (bPS)) in a crossover design. The results appear in Figures 1 and 2. In another study, 35 healthy subjects were given sHS at a dose of 0.2 mcg/kg. The results appear in Figures 1 and 2. FIGURE 1 FIGURE 2 The values obtained for Figures 1 and 2 were performed by investigators skilled in performing secretin stimulation testing and are to be taken only as guidelines.
These results should not be generalized to results of secretin stimulation testing conducted in other laboratories. However, a volume response of less than 2 mL/kg/hr, bicarbonate concentration of less than 80 mEq/L, and a bicarbonate output of less than 0.2 mEq/kg/hr are consistent with impaired pancreatic function. A physician or institution planning to perform secretin stimulation testing as an aid to the diagnosis of pancreatic disease should begin by assessing enough normal subjects (greater than 5) to develop proficiency in proper techniques and to generate normal response ranges for the commonly assessed parameters for pancreatic exocrine response to ChiRhoStim®. In three crossover studies evaluating 21 different patients with a documented history of chronic pancreatitis, sHS was compared to sPS and bPS at a dose of 0.2 mcg/kg for each drug.
All of the patients treated with these drugs had peak bicarbonate concentrations of less than 80 mEq/L. Pancreatic secretory response to intravenous synthetic human secretin in 35 healthy subjects demonstrated a mean peak bicarbonate concentration of 100 mEq/L and a mean total volume over one hour of 260.7 mL. All 35 subjects had peak bicarbonate concentrations greater than or equal to 80 mEq/L.
Stimulation of Gastrin Secretion to Aid in the Diagnosis of Gastrinoma ChiRhoStim®
administered intravenously stimulates gastrin release in patients with gastrinoma (Zollinger-Ellison Syndrome), whereas no or only small changes in serum gastrin concentrations occur in healthy subjects and in patients with duodenal ulcer disease. Discriminant analysis was used to establish secretin stimulation testing as an aid in the diagnosis of gastrinoma. An increase from basal levels of greater than or equal to 110 pg/mL was the optimal point separating positive and negative tests.
This gastrin response is the basis for the use of secretin as a provocative test in the evaluation of patients in whom gastrinoma is a diagnostic consideration. In a three way crossover study, 6 patients with tissue confirmed gastrinoma received synthetic human secretin (ChiRhoStim®), synthetic porcine secretin and biologically derived porcine secretin at a dose of 0.4 mcg/kg for each drug. Serum gastrin levels were reported to be greater than 110 pg/mL for all secretin products tested after stimulation.
Testing of ChiRhoStim® in 12 healthy subjects demonstrated completely negative results for gastrinoma.
Stimulation of Pancreatic Secretion to Facilitate Identification of the Ampulla of Vater
and the Accessory Papilla During Endoscopic Retrograde Cholangiopancreatography (ERCP) In a randomized, placebo controlled crossover study in 24 patients with pancreas divisum undergoing ERCP, ChiRhoStim® at a dose of 0.2 mcg/kg resulted in 16 of 24 successful cannulations of the minor duct compared to 2 of 24 for placebo. figure 1 figure 2
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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