Human Secretin
FDA Drug Information • Also known as: Chirhostim, Chirhostim 40
- Brand Names
- Chirhostim, Chirhostim 40
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION ChiRhoStim ® is a pure sterile, nonpyrogenic, lyophilized white cake powder acetate salt of secretin, a peptide hormone. ChiRhoStim ® has an amino acid sequence identical to the naturally occurring hormone consisting of 27 amino acids. Synthetic human secretin is chemically defined as follows: Molecular Weight 3039.44 Empirical Formula: C 130 H 220 N 44 O 39 CAS # 108153-74-8 Structural Formula: His-Ser-Asp-Gly-Thr-Phe-Thr-Ser-Glu-Leu-Ser-Arg-Leu-Arg-Glu-Gly-Ala-Arg-Leu-Gln-Arg-Leu-Leu-Gln-Gly-Leu-Val-NH 2 The standard unit of biological activity for ChiRhoStim ® is the clinical unit (CU). (2) One (1) CU of secretin biological activity is equal to 0.2 micrograms (mcg) of human secretin. ChiRhoStim ® is available in two strengths: As a 10 mL single-dose vial which contains 16 mcg of purified synthetic human secretin, 1.5 mg of L-cysteine hydrochloride, 20 mg of mannitol, and 9 mg of sodium chloride. When reconstituted in 8 mL of Sodium Chloride Injection USP, each mL of solution contains 2 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5. As a 10 mL single-dose vial which contains 40 mcg of purified synthetic human secretin, 3.75 mg of L-cysteine hydrochloride, 50 mg of mannitol, and 22.5 mg of sodium chloride per vial. When reconstituted in 10 mL of Sodium Chloride Injection USP, each mL of solution contains 4 mcg synthetic human secretin for intravenous use. The pH of the reconstituted solution has a range of 3 to 6.5.
What Is Human Secretin Used For?
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 and 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 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 the ChiRhoStim ® 16 mcg vial in 8 mL of 0.9% Sodium Chloride Injection, USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution. Inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is seen, discard the reconstituted solution. To reconstitute one 40 mcg vial: Dissolve the contents of the ChiRhoStim ® 40 mcg vial in 10 mL of 0.9% Sodium Chloride Injection, USP, to yield a concentration of 4 mcg/mL. Shake vigorously to ensure dissolution. Inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. If particulate matter or discoloration is seen, discard the reconstituted solution. Repeat steps above to reconstitute additional vials, as needed, to administer the total dose. Use immediately after reconstitution and discard any unused portion. 2.3 Administration and Test Methods Stimulation testing with ChiRhoStim ® should only be performed by physicians with sufficient expertise. Ensure that the institution has established normative ranges for pancreatic exocrine response. Stimulation of Pancreatic Secretions, including Bicarbonate, to Aid in the Diagnosis of Exocrine Pancreas Dysfunction: Preparation: Instruct patients to fast for at least 12 to 15 hours prior to beginning the test. Sample Collection: [performed using either the gastroduodenal/Dreiling tube (fluoroscopic) or endoscopic collection method] Gastroduodenal (Dreiling) Tube Collection Method Pass a radiopaque, double-lumen...
Side Effects (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, 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
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.
Contraindications
CONTRAINDICATIONS None. None (4)
Pregnancy and Breastfeeding
8.1 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.
How Supplied
HOW SUPPLIED/STORAGE AND HANDLING ChiRhoStim ® (human secretin), for injection is supplied as a white lyophilized sterile powder in a single-dose vial for reconstitution: NDC # 67066-005-01 16 mcg NDC # 67066-007-01 40 mcg Store at -20°C (freezer). Protect from light.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.