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ChiRhoStim

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Overview

What is ChiRhoStim?

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 H N O

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

The standard unit of biological activity for ChiRhoStim is the clinical unit (CU). 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 does ChiRhoStim look like?



What are the available doses of ChiRhoStim?

For injection: 16 mcg or 40 mcg of human secretin as a lyophilized powder in single-dose vial for reconstitution (3)

What should I talk to my health care provider before I take ChiRhoStim?

How should I use ChiRhoStim?

ChiRhoStim is indicated for the stimulation of:

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

Preparation of Recommended Dosage

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:

Sample Collection: [performed using either the gastroduodenal/Dreiling tube (fluoroscopic) or endoscopic collection method]

Sample Handling and Interpretation:

Stimulation of Gastrin Secretion to Aid in the Diagnosis of Gastrinoma:

Preparation:

Sample Collection:

Sample Interpretation:

Stimulation of Pancreatic Secretions to Facilitate the Identification of the Ampulla of Vater and Accessory Papilla During Endoscopic Retrograde Cholangiopancreatography (ERCP):

When difficulty is encountered by the endoscopist in identifying the ampulla of Vater or in identifying the accessory papilla in patients with pancreas divisum:


What interacts with ChiRhoStim?

None.



What are the warnings of ChiRhoStim?

Sorry No Records found


What are the precautions of ChiRhoStim?

Sorry No Records found


What are the side effects of ChiRhoStim?

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 ReactionArrayChiRhoStim®Number of PatientsN = 531
Nausea9
Vomiting3
Flushing2
Upset stomach2



What should I look out for while using ChiRhoStim?

None.


What might happen if I take too much ChiRhoStim?

Sorry No Records found


How should I store and handle ChiRhoStim?

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Dispense in a tight container [see USP].Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Dispense in a tight container [see USP].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 mcgNDC # 67066-007-01 40 mcgStore at -20°C (freezer). Protect from light.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 mcgNDC # 67066-007-01 40 mcgStore at -20°C (freezer). Protect from light.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 mcgNDC # 67066-007-01 40 mcgStore at -20°C (freezer). Protect from light.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 mcgNDC # 67066-007-01 40 mcgStore at -20°C (freezer). Protect from light.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

12.1 Mechanism of Action

The primary action of ChiRhoStim is to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate.

Secretin is a hormone that is normally released from the duodenum upon exposure of the proximal intestinal lumen to gastric acid, fatty acids and amino acids. Secretin is released from enterochromaffin cells in the intestinal mucosa. Secretin receptors have been identified in the pancreas, stomach, liver, colon and other tissues. When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid. Secretin may also work through vagal-vagal neural pathways since stimulation of the efferent vagus nerve stimulates bicarbonate secretion and atropine blocks secretin-stimulated pancreatic secretion.

Non-Clinical Toxicology
None.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

Absorption of tetracyclines is impaired by bismuth subsalicylate.

Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.

The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity.

Concurrent use of tetracycline may render oral contraceptives less effective.

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.



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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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