Included as part of the PRECAUTIONS section.

Allergic Reactions

Because of a potential allergic reaction to ChiRhoStim® 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® 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® cannot be ruled out.

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