ChiRhoStim

Contraindications

None

Cautions

Hyporesponse: Coadministration with anticholinergic drugs may cause a hyporesponse to stimulation testing (see Dosing Considerations)

Hyperresponse: Coadministration of H2-receptor antagonists or PPIs may cause a hyperresponse in gastrin secretion in response to stimulation testing, falsely suggesting gastrinoma (see Dosing Considerations)

Mechanism of Action

Stimulates 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

Pharmacokinetics

Half-Life: 45 min

Vd: 2.7 L

Total Body Clearance: 580±51.3 mL/min

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Flushing.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Secretin has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Secretin is only recommended for use during pregnancy when benefit outweighs risk.