FDA label 3fdaf566-184c-446f-e054-00144ff8d46c

WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Because of a potential hypersensitivity reaction to porcine secretin, all patients should receive an intravenous test dose of 0.2 mcg [see Dosage and Administration (2.1)] . If no hypersensitivity reaction is observed after one minute, the recommended dose of Porcine Secretin for Injection for the specific indication may be administered intravenously slowly over 1 minute. A test dose is especially important in patients with a history of atopy. Appropriate measures for the treatment of acute hypersensitivity reactions should be immediately available. 5.2 Hyporesponse to Secretin Stimulation Testing Patients who have undergone vagotomy, have inflammatory bowel disease or are receiving anticholinergic drugs at the time of stimulation testing with Porcine Secretin for Injection, may be hyporesponsive to secretin stimulation. Discontinue anticholinergic drugs at least 5 half-lives prior to stimulation testing [see Dosage and Administration (2.1)] . Consider additional testing and clinical assessments for aid in diagnosis. 5.3 Hyperresponse to Secretin Stimulation Testing Gastrin Secretion Patients receiving H 2 -receptor antagonists or PPIs at the time of stimulation testing with Porcine Secretin for Injection to aid in the diagnosis of gastrinoma may be hyperresponsive to secretin stimulation, falsely suggesting gastrinoma. Discontinue H 2 -receptor antagonists at least 2 days prior to stimulation testing. Consult the prescribing information of each specific PPI before administering Porcine Secretin for Injection [see Dosage and Administration (2.1)]. Pancreatic Secretions Patients with alcoholic or other liver disease may be hyperresponsive to stimulation with Porcine Secretin for Injection, masking the presence of coexisting pancreatic disease. Consider additional testing and clinical assessments for aid in diagnosis. Hypersensitivity Reactions : Administer a test dose and observe for one minute. If a reaction occurs, administer appropriate treatment. (2.1, 5.1) Hyporesponse to Secretin Stimulation Testing in Patients with Vagotomy, Inflammatory Bowel Disease or Receiving Anticholinergics : Discontinue anticholinergic drugs at least 5 half-lives prior to stimulation testing; consider additional testing and clinical assessments for aid in diagnosis. (2.1, 5.2, 7.1) Hyperresponse to Secretin Stimulation Testing : Increased gastrin secretion in patients receiving H 2 -receptor antagonists or PPIs falsely suggesting gastrinoma; discontinue co-administered drug prior to stimulation testing. Increased pancreatic secretions in patients with alcoholic or other liver disease masking coexisting pancreatic disease; consider additional testing and clinical assessments for aid in diagnosis. (2.1, 5.3, 7.2)

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 a single dose of Porcine Secretin for Injection in 957 patients in placebo and active controlled trials. The population consisted of patients ages 1 to 93, 379 males, 574 females, and 4 unspecified; 816 Caucasians, 106 Blacks, 10 Hispanics, 10 American Indians, 8 Asians, 1 Indian, 1 Native Alaskan, and 5 unspecified, with known or suspected diseases of the exocrine pancreas including chronic pancreatitis and pancreatic cancer. Most patients received a single dose of Porcine Secretin for Injection of 0.2 mcg/kg to 0.4 mcg/kg. The most common adverse reactions reported in at least 2% of patients in clinical trials are shown in Table 2. TABLE 2 Adverse Reactions in at Least 2% of Patients Treated with a Single-Dose of Porcine Secretin for Injection in Clinical Trials Adverse Reaction Porcine Secretin for Injection Percent Incidence (Number of Patients) N = 957 Abdominal discomfort 7 (7) Nausea 7 (7) Flushing 4 (4) Burning in stomach 3 (2) Diaphoresis 3 (2) Bradycardia 2 (2) Decreased blood pressure 2 (2) Most common adverse reactions (>=2%) are: abdominal discomfort, nausea flushing, burning in stomach, diaphoresis, bradycardia and decreased blood pressure. (6) 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: 10/2016

<table border="0" width="100%"> <caption>TABLE 2 Adverse Reactions in at Least 2% of Patients Treated with a Single-Dose of Porcine Secretin for Injection in Clinical Trials</caption> <tbody> <tr> <td> <content styleCode="bold">Adverse Reaction</content> </td> <td> <paragraph> <content styleCode="bold">Porcine Secretin for Injection</content> </paragraph> <paragraph> <content styleCode="bold">Percent Incidence (Number of Patients)</content> </paragraph> <paragraph> <content styleCode="bold">N = 957</content> </paragraph> </td> </tr> <tr> <td>Abdominal discomfort</td> <td>7 (7)</td> </tr> <tr> <td>Nausea</td> <td>7 (7)</td> </tr> <tr> <td>Flushing</td> <td>4 (4)</td> </tr> <tr> <td>Burning in stomach</td> <td>3 (2)</td> </tr> <tr> <td>Diaphoresis</td> <td>3 (2)</td> </tr> <tr> <td>Bradycardia</td> <td>2 (2)</td> </tr> <tr> <td>Decreased blood pressure</td> <td>2 (2)</td> </tr> </tbody> </table>