Medical Pharmacy Editor: Jay W. Marks, MD

GENERIC NAME: pramlintide

BRAND NAME: Symlin

DRUG CLASS AND MECHANISM: Pramlintide is an injectable drug that lowers the level of sugar (glucose) in blood. It is used for treating type 1 and type 2 diabetes. Pramlintide is a synthetic (man-made) hormone that resembles human amylin. Amylin is a hormone that is produced by the pancreas and released into the blood after meals where it helps the body to regulate levels of blood glucose. Amylin acts in several ways to control blood glucose. It slows the rate at which food (including glucose) is absorbed from the intestine. Amylin reduces the production of glucose by the liver by inhibiting the action of glucagon, a hormone produced by the pancreas that regulates the production of glucose by the liver. Amylin also reduces appetite. In studies, pramlintide-treated patients achieved lower blood glucose levels and experienced weight loss. Pramlintide was approved by the FDA in March, 2005.

PRESCRIPTION: Yes.

GENERIC AVAILABLE: No.

PREPARATIONS: Sterile injection: 5 ml vials, 0.6 mg/ml

STORAGE: Unopened vials should be refrigerated between 2-8°C (36-46°F). Opened vials should be refrigerated or kept at room temperature (no greater than 77°F, 25°C ) and used within 28 days.

PRESCRIBED FOR: Pramlintide is used in combination with other drugs for patients with type 1 or insulin requiring, type 2 diabetes who have uncontrolled blood glucose levels despite maximal therapy with other drugs.

DOSING: Pramlintide should be administered under the skin (subcutaneously) prior to major meals. Patients with type 1 diabetes should start treatment with a dose of 15 µg that is increased by 15 µg increments to 30 or 60 µg as tolerated. Treatment with type 2 diabetes should start treatment with 60 µg with the dose increasing to 120 µg as needed. Insulin doses should be reduced when pramlintide is started.

DRUG INTERACTIONS: Pramlintide slows the transit of digesting food through the intestine and, therefore, it should not be administered with other drugs that slow down the intestine (e.g., atropine) or slow the absorption of food (e.g., Acarbose).

Pramlintide may interfere with (slow) the absorption of orally administered drugs. To avoid this interaction, orally administered drugs that require rapid absorption should be administered 1 hour before or 2 hours after injections of pramlintide.

Insulin alters the chemical properties of pramlintide. Therefore, pramlintide and insulin should not be mixed in the same syringe.

PREGNANCY: There are no adequate studies of pramlintide in pregnant women.

NURSING MOTHERS: There are no adequate studies of pramlintide in nursing mothers, and it is not known if pramlintide is excreted in human breast milk.

SIDE EFFECTS: Common side effects of pramlintide include nausea, hypoglycemia (excessively low blood glucose), vomiting, headache, abdominal pain, weight loss and fatigue. Nausea decreases with continued administration of pramlintide and is less severe when pramlintide is slowly increased to the desired dose.

Last Editorial Review: 7/8/2005

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