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SYMLIN® (pramlintide acetate) injection. Please check back soon.

IMPORTANT SAFETY INFORMATION for SYMLIN (pramlintide acetate) injection

SEVERE HYPOGLYCEMIA: SYMLIN can cause serious side effects, including severe low blood sugar (hypoglycemia). Even when SYMLIN is carefully added to mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this severe low blood sugar happens, it is seen within 3 hours after a SYMLIN injection. Symptoms of severe low blood sugar and low blood sugar include: lightheadedness, dizziness, shakiness, sweating, hunger, fast heartbeat, trouble concentrating or confusion, change in vision, headache, irritability, and/or drowsiness.

Severe low blood sugar has led to injuries while driving, operating heavy machinery, or doing other dangerous activities. Until you know how SYMLIN affects you, do not drive, operate heavy machinery, or do other dangerous activities. Ask your healthcare provider what activities you should avoid.

Please see Medication Guide, Full Prescribing Information including Boxed WARNING, the SymlinPen 60 Pen-Injector Instructions for Use, and the SymlinPen 120 Pen-Injector Instructions for Use.

APPROVED USES

SYMLIN is an injectable prescription medicine used to treat adults with type 1 or type 2 diabetes to control blood sugar. SYMLIN is used when mealtime insulin dose has not controlled your blood sugar well enough.
It is not known if SYMLIN is safe and effective in children.

IMPORTANT SAFETY INFORMATION for SYMLIN (pramlintide acetate) injection

SEVERE HYPOGLYCEMIA: SYMLIN can cause serious side effects, including severe low blood sugar (hypoglycemia). Even when SYMLIN is carefully added to mealtime insulin therapy, your blood sugar may drop too low, especially if you have type 1 diabetes. If this severe low blood sugar happens, it is seen within 3 hours after a SYMLIN injection. Symptoms of severe low blood sugar and low blood sugar include: lightheadedness, dizziness, shakiness, sweating, hunger, fast heartbeat, trouble concentrating or confusion, change in vision, headache, irritability, and/or drowsiness.

Severe low blood sugar has led to injuries while driving, operating heavy machinery, or doing other dangerous activities. Until you know how SYMLIN affects you, do not drive, operate heavy machinery, or do other dangerous activities. Ask your healthcare provider what activities you should avoid.

Talk to your healthcare provider about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon for injection with you at all times. Call your healthcare provider if you have severe low blood sugar or have low blood sugar more often than normal.

Your chance for severe low blood sugar is higher if you:

  • do not follow your healthcare provider's instructions to reduce your insulin use before meals
  • use more SYMLIN or insulin than prescribed by your healthcare provider
  • change your insulin dose without checking your blood sugar
  • eat less food than your usual meal
  • are sick and cannot eat
  • are more active than usual
  • have a low blood sugar level before eating
  • drink alcohol

Do not use SYMLIN if you are allergic to SYMLIN or any of its ingredients, cannot tell when your blood sugar is low, or have a problem with your stomach not emptying as fast as it should (gastroparesis).

Do not share your SymlinPen with another person, even if the needle is changed. You may give another person a serious infection or get a serious infection from them.

Tell your healthcare provider about all of your medical conditions, including if you are pregnant, breast-feeding or plan to become pregnant or breast-feed. It is unknown if SYMLIN can harm your unborn baby or if SYMLIN passes into your milk.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. SYMLIN slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Use SYMLIN exactly as your healthcare provider tells you to use it. Also, read the Instructions for Use and Medication Guide that come with your SYMLIN.

  • SYMLIN is used with insulin and is taken at mealtimes. SYMLIN does not replace your daily insulin but may lower the amount of insulin you need. When starting SYMLIN, you will need to reduce your dose of mealtime insulin. Your healthcare provider will tell you how to reduce your dose of mealtime insulin the right way
  • If you stop taking SYMLIN for any reason, such as surgery or illness, talk to your healthcare provider about how to re-start SYMLIN
  • To reduce the risk of hypoglycemia, plan what you will eat, when you will eat your meals, and your physical activity every day while you use SYMLIN
  • If you forget or miss a dose of SYMLIN, wait until the next meal and take your usual dose of SYMLIN at that meal
  • Tell your healthcare provider right away if you have nausea or low blood sugar after your dose of SYMLIN is changed

Never mix SYMLIN and insulin. Insulin can affect SYMLIN when they are mixed together.

SYMLIN may cause serious side effects, including severe low blood sugar (hypoglycemia) and injection site reactions, such as bruising, swelling, or itching at the injection site.

The most common side effects of SYMLIN include nausea, vomiting, decreased appetite, stomach pain, and headache. Tell your healthcare provider if you have any side effects that bother you or that do not go away.

APPROVED USES

SYMLIN is an injectable prescription medicine used to treat adults with type 1 or type 2 diabetes to control blood sugar. SYMLIN is used when mealtime insulin dose has not controlled your blood sugar well enough.
It is not known if SYMLIN is safe and effective in children.

Please see the links below for the Medication Guide, Full Prescribing Information including Boxed WARNING, the SymlinPen 60 Pen-Injector Instructions for Use, and the SymlinPen 120 Pen-Injector Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.