ChiRhoStim 40 40 ug/10mL
Human Secretin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · ChiRhoClin, Inc.
ChiRhoStim 40 is a injection, powder, lyophilized, for solution containing human secretin at 40 ug/10mL, taken intravenous. Manufactured by ChiRhoClin, Inc..
Key Facts
- Brand Name
- ChiRhoStim 40
- Generic Name
- Human Secretin
- NDC Code (Product)
67066-007- Manufacturer
- ChiRhoClin, Inc.
- Strength
- 40 ug/10mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA021256
- Marketing Start
- 06/21/2007
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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 (1) gastrin secretion to aid in the diagnosis of gastrinoma (1) pancreatic secretions to facilitate the identification of the ampulla of Vater and the accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP) (1)
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 …
Contraindications
CONTRAINDICATIONS None. None (4)
Drug Interactions
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 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.
Adverse Reactions
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, vom…
Frequently Asked Questions
What is ChiRhoStim 40 used for?
ChiRhoStim 40 contains Human Secretin. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is ChiRhoStim 40 a controlled substance?
ChiRhoStim 40 is not classified as a controlled substance by the DEA.
What is the generic name for ChiRhoStim 40?
The generic name for ChiRhoStim 40 is Human Secretin. There are 1 other brand versions of Human Secretin.
What is the NDC code for ChiRhoStim 40 40 ug/10mL?
The NDC (National Drug Code) for ChiRhoStim 40 40 ug/10mL is 67066-007, listed by ChiRhoClin, Inc..