Drug: ChiRhoStim

Human secretin is a gastrointestinal peptide hormone produced by cells in the duodenum in response to acidification. ChiRhoStim® (human secretin as the acetate) is a purified synthetic peptide with an amino acid sequence identical to the naturally occurring hormone. Synthetic human secretin is chemically defined as follows: Molecular Weight 3039.44
Empirical Formula: C130H220N44O39
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-NH2 ChiRhoStim® (human secretin) is available in two strengths:
  • As a 10 ml 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 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.
Last reviewed on RxList: 7/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Mild to moderate adverse reactions have been noted  for synthetic human secretin in clinical studies in 533 patients   and 51 healthy volunteers. Two severe adverse reactions, nausea   and abdominal pain, occurred in one patient. Table 1 details   the type and number of patients with adverse reactions. TABLE 1 ADVERSE REACTIONS WITH CHIRHOSTIM® (human secretin) Adverse Reaction N = 584
Incidence
(Patients) Nausea 11(11) Flushing 4 (4) Early removal of Dreiling tube 3 (3) Abdominal pain 3 (3) Vomiting 3 (3) Increased heart rate 2 (2) Mild Pancreatitis 2 (2) Upset stomach 2 (2) Anxiety 1 (1) Burning in stomach or abdomen 1 (1) Clammy skin 1 (1) Decreased O2 saturation 1 (1) Diarrhea 1 (1) Faintness 1 (1) Hypotension 1 (1) Infiltrated IV 1 (1) Oral secretions increased 1 (1) Sedation 1 (1) Slow heart rate (57 bpm) 1 (1) Tingling in legs 1 (1) Unresponsive 1 (1) Warm sensation in abdomen 1 (1) Warm sensation in face 1 (1) Of the 584 patients and healthy volunteers treated with ChiRhoStim® (human secretin) , a total of 29 patients (5%) had at least one adverse reaction. Read the ChiRhoStim (human secretin) Side Effects Center for a complete guide to possible side effectsLearn More »

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Stimulation of Pancreatic Secretions, Including Bicarbonate to Aid in the Diagnosis of Exocrine Pancreas Dysfunction: 0.2 mcg/kg body weight by intravenous injection over 1 minute. Gastroduodenal (Dreiling) Tube Collection Method(1): A radiopaque, double-lumen tube is passed through the mouth following a 12-15 hour fast. Under fluoroscopic control, the opening of the proximal lumen of the tube is placed in the gastric antrum and the opening of the distal lumen just beyond the papilla of Vater. The positioning of the tube must be confirmed and the tube secured prior to synthetic human secretin testing. Intermittent negative pressure of 25-40 mmHg is applied to both lumens and maintained throughout the test. When duodenal contents have a pH of ≥ 6, a baseline sample of duodenal fluids is collected for a 10 minute period. A test dose of ChiRhoStim® (human secretin) 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, ChiRhoStim® (human secretin) at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. Duodenal fluid is collected for 60 minutes thereafter. The aspirate is divided into four collection periods of fifteen minutes each. The duodenal lumen of the tube is cleared with an injection of air after collection of each sample. Wide variation in volume of the aspirate is indicative of incomplete aspiration. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L. Endoscopic Collection Method: Endoscopic Pancreatic Function Test (ePFT)(2-4): After assessment of patients for sedation and analgesia, a test dose of ChiRhoStim® (human secretin) 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. After one minute, if there are no signs of allergic reaction, ChiRhoStim® (human secretin) at a dose of 0.2 mcg/kg of body weight is injected intravenously over 1 minute. An upper endoscopy is performed with conscious sedation, after topical anesthetic. All gastric fluid is aspirated through the endoscope and discarded. After small bowel intubation to the junction of the second and third portion of the duodenum, fluid is aspirated for 1 to 3 minutes and collected in 5 separate specimen traps at baseline (0), 15, 30, 45, and 60 minutes after secretin injection. The patients remain intubated with the upper endoscope for one hour in the left lateral decubitus position. Boluses of meperidine and midazolam in a 25:1 mg ratio are administered to maintain analgesia and sedation during the 1-hour procedure. Each sample of duodenal fluid is to be chilled and subsequently analyzed for volume and bicarbonate concentration. Exocrine pancreas dysfunction typically associated with chronic pancreatitis is indicated if the peak bicarbonate concentration for any sample ≤ 80 mEq/L. Stimulation of Gastrin Secretion to Aid in Diagnosis of Gastrinoma: 0.4 mcg/kg body weight by intravenous injection over 1 minute. The patient should fast for at least 12 hours prior to beginning the test. Prior to injection of ChiRhoStim® (human secretin) , two blood samples are drawn for determination of fasting serum gastrin levels (baseline values). Subsequently, a test dose of ChiRhoStim® (human secretin) 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, ChiRhoStim® (human secretin) at a dose of 0.4 mcg/kg of body weight is injected intravenously over 1 minute; post-injection blood samples are collected after 1, 2, 5, 10, and 30 minutes for determination of serum gastrin concentrations. Gastrinoma is strongly indicated in patients who show an increase in serum gastrin concentrations of 110 pg/mL over basal level on any of the post injection samples. Facilitation of the Identification   of the Ampulla of Vater and Accessory Papilla During         Endoscopic Retrograde Cholangiopancreatography (ERCP) to aid    in cannulation of the pancreatic duct: 0.2 mcg/kg body weight by intravenous injection over 1 minute. Administration of ChiRhoStim® (human secretin) may be given when difficulty is encountered by the endoscopist in identifying the ampulla of Vater for various reasons including: anatomic deformity secondary to prior surgery, radiation therapy, peptic ulcer disease, tumors, etc. or in identifying the accessory papilla in patients with pancreas divisum. A test dose of ChiRhoStim® (human secretin) 0.2 mcg if using the 16 mcg vial (0.1 mL) or 0.4 mcg if using the 40 mcg vial (0.1 mL) is injected intravenously to test for possible allergies. If there are no signs of allergic reaction, a dose of 0.2 mcg/kg of body weight intravenously over 1 minute may be administered and will result in visible excretion of pancreatic fluid from the orifices of these papillae enabling their identification and facilitating their cannulation. Administration ChiRhoStim® (human secretin) 16 mcg vial: Dissolve the contents of the ChiRhoStim® (human secretin) 16 mcg vial in 8 mL of Sodium Chloride Injection USP, to yield a concentration of 2 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion. ChiRhoStim® (human secretin) 40 mcg vial: Dissolve the contents of the ChiRhoStim® (human secretin) 40 mcg vial in 10 mL of Sodium Chloride Injection USP, to yield a concentration of 4 mcg/mL. Shake vigorously to ensure dissolution. Use immediately after reconstitution and discard any unused portion. For both strengths, the reconstituted drug product should be inspected visually prior to administration. If particulate matter or discoloration is seen, the product should be discarded. Dosage forms and strengths ChiRhoStim® (human secretin) is available in two strengths: As a lyophilized sterile powder in 10 mL vials containing 16 mcg of human secretin. As a lyophilized sterile powder in 10 mL vials containing 40 mcg of human secretin.

Source: http://www.rxlist.com

The concomitant use of anticholinergic agents may make patients hyporesponsive to secretin stimulation and may produce a false result. Any results of secretin stimulation tests in these patients should thus be interpreted with caution.Last reviewed on RxList: 7/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

ChiRhoStim® (human secretin) is indicated for: Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and Facilitation of the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).

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Patients suffering from acute pancreatitis should not receive ChiRhoStim® (human secretin) until the acute episode has subsided.Last reviewed on RxList: 7/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

STORAGE AND HANDLING ChiRhoStim® (human secretin) 16 mcg vial NDC # 67066-005-01 ChiRhoStim® (human secretin) 40 mcg vial NDC # 67066-007-01 Supplied ChiRhoStim® (human secretin) is supplied in two strengths: As a lyophilized sterile powder in vials containing 16 mcg of human secretin. As a lyophilized sterile powder in vials containing 40 mcg of human secretin. Storage The unreconstituted product should be stored at -20°C (freezer). Expiration date is marked on the label. Protect from light. REFERENCES 1. Dreiling DA. Pancreatic secretory testing in 1974. Gut. 1975;16(8):653-7. 2. Stevens T, Conwell DL, Zuccaro G Jr, Van Lente F, Purich E, Khandwala F, Fein S. A randomized crossover study of secretin-stimulated endoscopic and dreiling tube pancreatic function test methods in healthy subjects. Am J Gastroenterol. 2006 Feb;101(2):351-5. 3.    Yadav D, Chari ST. The Endoscopic Pancreatic Exocrine Function Test (ePFT): Can it be the New "Gold Standard"? Gastroenterology 2006 Oct;131(4):1349-1350. 4.    Conwell DL, Zuccaro G, Purich E, Fein S, Vanlente F, Vargo J, Dumot J, O'laughlin C, Trolli P. The effect of moderate sedation on exocrine pancreas function in normal healthy subjects: a prospective, randomized, cross-over trial using the synthetic porcine secretin stimulated Endoscopic Pancreatic Function Test (ePFT). Am J Gastroenterol. 2005 May;(5):1161-6. ChiRhoStim® (human secretin) is a registered trademark of ChiRhoClin, Inc. Manufactured for: ChiRhoClin, Inc Burtonsville, MD 20866-6129 Manufactured by: Bell-More Labs, Inc. Hampstead, Maryland 21074-0179. FDA Rev date: 6/21/2007Last reviewed on RxList: 7/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Allergic Reactions Because of a potential allergic reaction to ChiRhoStim® (human secretin) patients should receive an intravenous test dose of 0.1 mL of the respective reconstituted vial. If no signs of allergic reaction are noted after one minute, the recommended dose may be injected slowly over 1 minute. A test dose is especially important in patients with a history of atopic allergy and/or asthma. Appropriate measures for the treatment of acute hypersensitivity reactions should be immediately available. No allergic reactions were observed after the test dose or full dose of synthetic human secretin in 584 patients and volunteers. Vagotomy or Inflammatory Bowel Disease Patients who have undergone vagotomy or who have inflammatory bowel disease may be hyporesponsive to secretin stimulation. This response does not indicate pancreatic disease, and results of secretin stimulation tests in these patients should be interpreted with caution. Alcoholic or Liver Disease A greater than normal volume response to secretin stimulation, which may mask coexisting pancreatic disease, is occasionally encountered in patients with alcoholic or other liver disease. Results of secretin stimulation tests in these patients should thus be interpreted with caution. NonClinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of synthetic human secretin. Studies to evaluate the potential for impairment of fertility or mutagenicity of synthetic human secretin have not been performed. Use in Specific Populations Pregnancy Animal reproduction studies have not been conducted with synthetic human secretin. It is also not known whether synthetic human secretin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Synthetic human secretin should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether synthetic human secretin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when synthetic human secretin is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Among the 533 patients who have received ChiRhoStim® (human secretin) in clinical trials 18% were 65 years of age or older and 6% were 75 years of age or older. Dosing was the same as that for the overall population of patients. No overall differences in safety, pharmacologic response, or diagnostic effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and the younger patients, but greater sensitivity of some older individuals to ChiRhoStim® (human secretin) cannot be ruled out. Last reviewed on RxList: 7/17/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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