chirhostim

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…

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.…

None. None (4)

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 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.