CHIRHOSTIM

Pharmacokinetics 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. The elimination half-life of synthetic human secretin is 45 minutes. The clearance of synthetic human secretin is 580.9 ± 51.3 mL/min and the volume of distribution is 2.7...

CLINICAL STUDIES 14.1 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 document...

ADVERSE REACTIONS 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...

CONTRAINDICATIONS None. None (4)

WARNINGS AND PRECAUTIONS 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 te...

DRUG INTERACTIONS 7.1 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 ® [see Dosage and Administration (2.1)] . 7.2 Hyperresponse of Gastrin Secretion with H 2 -Receptor Antagonists and PPIs The concomitant use of H...