SYMLIN- pramlintide acetate injection 
SYMLINPEN- pramlintide acetate injection 
Amylin Pharmaceuticals, Inc.

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Medication Guide

SYMLIN® (SĬM-lĭn)
(pramlintide acetate) injection

Read the Medication Guide and the "Patient Instructions for Use" that come with your SYMLIN product before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

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


  • SYMLIN is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
  • SYMLIN is given at mealtimes. The use of SYMLIN does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
  • Even when SYMLIN 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 seen within 3 hours after a SYMLIN 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.
  • SYMLIN should only be used by people with type 2 and type 1 diabetes who:
    • already use their insulin as prescribed, but still need better blood sugar control.
    • will follow their doctor's instructions exactly.
    • will follow up with their doctor often.
    • will test their blood sugar levels before and after every meal, and at bedtime.
    • understand how to adjust SYMLIN and insulin doses.

What is SYMLIN?

SYMLIN is an injectable medicine for adults with type 2 and type 1 diabetes to control blood sugar. SYMLIN slows down the movement of food through your stomach. This affects how fast sugar enters your blood after eating. SYMLIN is always used with insulin to help lower blood sugar during the 3 hours after meals.

Who should not use SYMLIN?

Do not use SYMLIN if you:

SYMLIN has not been studied in children.

What should I tell my doctor before starting SYMLIN?

Tell your doctor about all of your medical conditions including if you:

Keep a list of all the medicines you take. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SYMLIN can slow down how other medicines pass through your stomach and may affect how much of them get into your body. You may have to change the times you take certain medicines.

How should I use SYMLIN?

Using SYMLIN and insulin with Type 2 Diabetes

  1. Start SYMLIN 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.
  2. Reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN to 120 mcg on your doctor's instructions if you have not had any nausea for 3 days or more.
  5. 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 SYMLIN.
  6. Your doctor may make changes to your insulin doses to better control your blood sugar once you are using the 120 mcg dose of SYMLIN. All insulin changes should be directed by your doctor.

Using SYMLIN and insulin with Type 1 Diabetes

  1. Start SYMLIN 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.
  2. When starting SYMLIN, reduce your rapid-acting or short-acting insulin, including fixed-mix insulin such as 70/30, used before meals by 50 percent. This means half of the dose you usually use. All insulin changes should be directed by your doctor.
  3. You must check your blood sugar before and after every meal and at bedtime.
  4. Increase your dose of SYMLIN 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 SYMLIN at 30 mcg, call your doctor right away. Your doctor may decide that you should stop SYMLIN.
  5. Increase your dose of SYMLIN 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.
  6. Increase your dose of SYMLIN 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.
  7. 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 SYMLIN to the 30 mcg dose.
  8. Your doctor may make changes to your insulin doses to better control your blood sugar once you are on a dose of SYMLIN that is right for you. All insulin changes should be directed by your doctor.

Staying on SYMLIN

When should I not use SYMLIN?

Do not use SYMLIN if:

Talk to your doctor if you have any of these conditions.

What should I avoid while taking SYMLIN?

What are the possible side effects of SYMLIN?

Low blood sugar (hypoglycemia)

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

Nausea

Nausea is the most common side effect with SYMLIN. Mild nausea is more likely during the first weeks after starting SYMLIN and usually does not last long. It is very important to start SYMLIN at a low dose and increase it as directed by your doctor. See "How should I use SYMLIN?" If nausea continues or bothers you, call your doctor right away.

Other Side Effects

SYMLIN also may cause the following side effects: decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion.

SYMLIN also can cause reactions at the injection site including redness, minor bruising, or pain. See the detailed "Patient Instructions for Use." Follow the directions under "How should I use SYMLIN?" to reduce the chance of an injection site reaction.

Tell your doctor if you have any side effects that bother you or that do not go away.

These are not all the side effects with SYMLIN. Ask your doctor or pharmacist for more information.

How should I store SYMLIN?

Keep SYMLIN and all medicines out of the reach of children.

General information about the safe and effective use of SYMLIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMLIN for a condition for which it was not prescribed. Do not give SYMLIN to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SYMLIN. Also see the "Patient Instructions for Use" on using the SymlinPen® pen-injector or vial. You can ask your doctor for more about SYMLIN, including information that is written for doctors.

More information on SYMLIN can be found at http://www.SYMLIN.com.

SYMLIN Customer Service is available 24 hours a day at 1-800-349-8919.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in SYMLIN?

Active ingredient: pramlintide acetate
Inactive ingredients: metacresol, D-mannitol, acetic acid, and sodium acetate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Literature Revised July 2008

Manufactured for Amylin Pharmaceuticals, Inc.
San Diego CA 92121, USA
1-800-349-8919
http://www.SYMLIN.com

SYMLIN and SymlinPen are registered trademarks of Amylin Pharmaceuticals, Inc. Copyright © 2005-2008, Amylin Pharmaceuticals, Inc. All rights reserved.

813006-FF

Revised: 08/2009
 
Amylin Pharmaceuticals, Inc.