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What is the most important information I should know about pramlintide?

Even when pramlintide is carefully added to your mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this low blood sugar (severe hypoglycemia) happens, it is generally seen within 3 hours after a pramlintide injection. Severe low blood sugar makes it hard to think clearly, drive a car, use heavy machinery or do other risky activities where you could hurt yourself or others.

Pramlintide should only be used by people with type 1 or type 2 diabetes who already use their insulin as prescribed but still need better blood sugar control. Patients taking pramlintide should follow their doctor's instructions exactly, follow up with their doctor often, test their blood sugar levels before and after every meal and at bedtime, and understand how to adjust pramlintide and insulin doses.

Never mix pramlintide and insulin. You must use different syringes for pramlintide and insulin because insulin can affect pramlintide when the two are mixed together.

What is pramlintide?

Pramlintide is an injectable medicine for adults with type 1 and type 2 diabetes to control blood sugar.

Pramlintide slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. Pramlintide is always used with insulin to help lower blood sugar during the 3 hours after meals.

Pramlintide may also be used for purposes other than those listed in this medication guide.

What should I discuss with my health care provider before taking pramlintide ?

Do not use pramlintide if you:

• cannot tell when your blood sugar is low (hypoglycemia unawareness); or

• have a stomach problem called gastroparesis (the stomach does not empty as fast as it should);

You may not be able to take pramlintide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Pramlintide is in the FDA pregnancy category C. This means that it is not known whether pramlintide will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Pramlintide passes into breast milk in small amounts and may affect a nursing baby. Do not take pramlintide without first talking to your doctor if you are breast-feeding a baby.

How should I take pramlintide?

You must use pramlintide exactly as prescribed. The amount of pramlintide you use will depend on whether you have type 1 or type 2 diabetes. You and your doctor will decide if you can use pramlintide.

Never mix pramlintide and insulin. You must use different syringes for pramlintide and insulin because insulin can affect pramlintide when the two are mixed together.

Injecting pramlintide is similar to injecting insulin. Inject pramlintide under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject pramlintide at a site that is more than 2 inches away from your insulin injection. Allow pramlintide to warm to room temperature before injecting. Use a U-100 insulin syringe (best to use 0.3 mL [0.3 cc] size) to draw-up and inject pramlintide. Always use a new syringe and needle for each pramlintide injection.

Do not use pramlintide if the liquid in the vial looks cloudy.

Always have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon available to treat low blood sugar.

Using pramlintide and insulin with Type 2 Diabetes: (See the table included with the product labeling to match your pramlintide dose to insulin syringe units.)

• Start pramlintide at 60 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

• Reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use.

• You must check your blood sugar before and after every meal and at bedtime.

• Increase your dose of pramlintide to 120 mcg on your doctor's instructions if you have not had any nausea for 3 days or more.

• Tell your doctor right away if you have nausea with the 120 mcg dose. Your doctor will tell you how to adjust your dose of pramlintide.

• Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of pramlintide. All insulin changes should be directed by your doctor.

Using pramlintide and insulin with Type 1 Diabetes: (See the table included with the product labeling to match your pramlintide dose to insulin syringe units.)

• Start pramlintide at 15 mcg injected under your skin, just before major meals. A major meal must have at least 250 calories or 30 grams of carbohydrate.

• When starting pramlintide, reduce your rapid-acting or short-acting insulin doses before meals by 50 percent, including fixed-mix insulins such as 70/30. This means half of the dose you usually use. All insulin changes should be directed by your doctor.

• You must check your blood sugar before and after every meal and at bedtime.

• Increase your dose of pramlintide to 30 mcg on your doctor's instructions if you have not had any nausea for 3 days or more. If you have nausea with pramlintide at 30 mcg, call your doctor right away. Your doctor may decide that you should stop pramlintide.

• Increase your dose of pramlintide to 45 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 30 mcg dose.

• Increase your dose of pramlintide to 60 mcg on your doctor's instructions if you have not had any nausea for 3 days or more while using the 45 mcg dose.

• Call your doctor right away if you are bothered with nausea on the 45 mcg or 60 mcg dose. Your doctor may decide that you should reduce pramlintide to the 30 mcg dose.

• Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of pramlintide that is right for you. All insulin changes should be directed by your doctor.

Once you reach your recommended dose of pramlintide, talk to your doctor about changing your insulin doses to better control your blood sugar. You may have to increase your long-acting insulin to prevent high blood sugar (hyperglycemia) between meals. Insulin changes should be directed by your doctor based on blood sugar testing.

If you stop taking pramlintide for any reason, such as surgery or illness, call your doctor.

Store pramlintide vials in the refrigerator until you open them. Opened vials can be refrigerated or kept at room temperature for up to 28 days. Any opened vial should be thrown away after 28 days, even if it still has medicine in it. Throw away any vial that is out-of-date, has been frozen, heated above room temperature (77 F/25 C) or left at room temperature for more than 28 days.