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warnings and cautions
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 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 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
adverse reactions table
<table border="1" cellpadding="0" cellspacing="0"><tbody><tr><td><paragraph>Adverse Reaction</paragraph><paragraph/></td><td><paragraph>ChiRhoStim®</paragraph><paragraph>Number of Patients</paragraph><paragraph>N = 531</paragraph></td></tr><tr><td><paragraph>Nausea</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph>Vomiting</paragraph></td><td><paragraph>3</paragraph></td></tr><tr><td><paragraph>Flushing</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph>Upset stomach</paragraph></td><td><paragraph>2</paragraph></td></tr></tbody></table>