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Symlin

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Symlin

PATIENT INFORMATION

Medication Guide

SYMLIN®
(SiM-lin)
(pramlintide acetate) injection

Read the Medication Guide and the "Patient Instructions for Use" that come with your SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) ?

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower blood sugar, especially high blood sugar that happens after meals.
  • SYMLIN (pramlintide acetate injection) is given at mealtimes. The use of SYMLIN (pramlintide acetate injection) does not replace your daily insulin but may lower the amount of insulin you need, especially before meals.
  • Even when SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) and insulin doses.

What is SYMLIN (pramlintide acetate injection) ?

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

Who should not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if you:

  • cannot tell when your blood sugar is low (hypoglycemia unawareness).
  • have a stomach problem called gastroparesis. This is when your stomach does not empty as fast as it should.
  • are allergic to SYMLIN (pramlintide acetate injection) or any ingredients in SYMLIN (pramlintide acetate injection) . See the end of this Medication Guide for a complete list of ingredients.

SYMLIN (pramlintide acetate injection) has not been studied in children.

What should I tell my doctor before starting SYMLIN (pramlintide acetate injection) ?

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

  • are pregnant or planning to become pregnant. It is not known if SYMLIN (pramlintide acetate injection) can harm your unborn baby. You and your doctor will decide how to best control your blood sugar levels during pregnancy.
  • are breastfeeding. It is not known if SYMLIN (pramlintide acetate injection) passes into your milk and if it can harm your baby. You and your doctor will decide the best way to feed your baby if you are using SYMLIN (pramlintide acetate injection) .

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 (pramlintide acetate injection) 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 (pramlintide acetate injection) ?

  • You must use SYMLIN (pramlintide acetate injection) exactly as prescribed. The amount of SYMLIN (pramlintide acetate injection) you use will depend on whether you have type 2 or type 1 diabetes. You and your doctor will decide if you can use SYMLIN (pramlintide acetate injection) .
  • It is important for you to carefully read, understand and follow the "Patient Instructions for Use" that comes along with this Medication Guide and your SYMLIN (pramlintide acetate injection) .
  • SYMLIN (pramlintide acetate injection) is available in vials and two Symlin (pramlintide acetate injection) Pen™ pen-injectors. Your doctor will prescribe the type of SYMLIN (pramlintide acetate injection) that is right for you.
    • If you have been using the SYMLIN (pramlintide acetate injection) vial with an insulin syringe and you are changing to the Symlin (pramlintide acetate injection) Pen™ pen-injector: Your doctor will prescribe the Symlin (pramlintide acetate injection) Pen™ pen- injector that is right for you, tell you how much SYMLIN (pramlintide acetate injection) to inject and when to inject it.
    • It is important that you understand how to inject the right SYMLIN (pramlintide acetate injection) dose. Read the "Patient Instructions for Use" carefully BEFORE giving your first dose with the Symlin (pramlintide acetate injection) Pen™ pen-injector. The SYMLIN (pramlintide acetate injection) in the pen-injector is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.
  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. Do not inject SYMLIN (pramlintide acetate injection) and insulin in the same site.
  • To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting.
  • Use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Do not use SYMLIN (pramlintide acetate injection) if the liquid looks cloudy.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. If you take more SYMLIN (pramlintide acetate injection) than your prescribed dose, pay careful attention to the amount of insulin you use because you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Using SYMLIN (pramlintide acetate injection) and insulin with Type 2 Diabetes

  1. Start SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) .
  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 (pramlintide acetate injection) . All insulin changes should be directed by your doctor.

Using SYMLIN (pramlintide acetate injection) and insulin with Type 1 Diabetes

  1.  Start SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) , 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) at 30 mcg, call your doctor right away. Your doctor may decide that you should stop SYMLIN (pramlintide acetate injection) .
  5. Increase your dose of SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) 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 (pramlintide acetate injection) that is right for you. All insulin changes should be directed by your doctor.

Staying on SYMLIN (pramlintide acetate injection)

  • Once you reach your recommended dose of SYMLIN (pramlintide acetate injection) , 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 always be directed by your doctor based on blood sugar testing.
  • Call your doctor if nausea or low blood sugar continues while on your recommended dose of SYMLIN (pramlintide acetate injection) . Low blood sugar that happens often is a warning sign of possible severe low blood sugar, especially if you have type 1 diabetes.
  • If you stop taking SYMLIN (pramlintide acetate injection) for any reason, such as surgery or illness, talk to your doctor about how to re-start SYMLIN (pramlintide acetate injection) .

When should I not use SYMLIN (pramlintide acetate injection) ?

Do not use SYMLIN (pramlintide acetate injection) if:

  • your blood sugar is too low.
  • you do not plan to eat. Do not inject SYMLIN (pramlintide acetate injection) if you skip a meal.
  • you plan to eat a meal with less than 250 calories or 30 grams of carbohydrate.
  • you are sick and can't eat your usual meal.
  • you are having surgery or a medical test where you cannot eat.
  • you are pregnant or breastfeeding and have not talked to your doctor. Talk to your doctor if you have any of these conditions.

What should I avoid while taking SYMLIN (pramlintide acetate injection) ?

  • Do not drive or operate dangerous machinery until you know how SYMLIN (pramlintide acetate injection) affects your blood sugar. 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. Discuss with your doctor what activities you should avoid.
  • Alcohol may increase the risk of low blood sugar.
  • Your doctor will tell you which medicines you can take while using SYMLIN (pramlintide acetate injection) . Do not take other medicines that slow stomach emptying.

What are the possible side effects of SYMLIN (pramlintide acetate injection) ?

Low blood sugar (hypoglycemia)

  • SYMLIN (pramlintide acetate injection) is used with insulin to lower your blood sugar, but your blood sugar may drop too low, especially if you have type 1 diabetes. See "What is the most important information I should know about SYMLIN (pramlintide acetate injection) ?"
  • When starting SYMLIN (pramlintide acetate injection) , reduce your doses of insulin before meals as recommended by your doctor to reduce the chance of low blood sugar. You and your doctor should talk about a plan to treat low blood sugar. You should have fast-acting sugar (such as hard candy, glucose tablets, juice) or glucagon with you at all times. Call your doctor if you have low blood sugar more often than normal or severe low blood sugar.

Your chance for low blood sugar is higher if you:

  • do not reduce your insulin dose before meals at the beginning of SYMLIN (pramlintide acetate injection) treatment, as directed by your doctor.
  • use more SYMLIN (pramlintide acetate injection) or insulin than prescribed by your doctor.
  • 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.

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

Other Side Effects: SYMLIN (pramlintide acetate injection) also may cause the following side effects: decreased appetite, vomiting, stomach pain, tiredness, dizziness, or indigestion.

SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) ?" 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 (pramlintide acetate injection) . Ask your doctor or pharmacist for more information.

How should I store SYMLIN (pramlintide acetate injection) ?

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial or pen-injector has been used for the first time, it can be refrigerated or kept at a temperature up to 86F (30C) for 30 days. Do not leave above 86F (30C). Any vial or pen-injector in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen. Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children.

General information about the safe and effective use of SYMLIN (pramlintide acetate injection)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMLIN (pramlintide acetate injection) for a condition for which it was not prescribed. Do not give SYMLIN (pramlintide acetate injection) 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 (pramlintide acetate injection) . Also see the "Patient Instructions for Use" on using the Symlin (pramlintide acetate injection) Pen™ pen-injector or vial. You can ask your doctor for more about SYMLIN (pramlintide acetate injection) , including information that is written for doctors.

More information on SYMLIN (pramlintide acetate injection) can be found at http://www.SYMLIN (pramlintide acetate injection) .com. SYMLIN (pramlintide acetate injection) Customer Service is available 24 hours a day at 1-800-349-8919.

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.

Patients Instructions for Use
Read the Medication Guide first.

These instructions do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you have questions or concerns about SYMLIN (pramlintide acetate injection) , please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1-800-349-8919

Prepare and inject your dose

  1. Inspect your SYMLIN (pramlintide acetate injection) vial. The liquid in the vial should be clear and colorless.
  2. Check the expiration date (EXP) on the label to be sure your SYMLIN (pramlintide acetate injection) is not expired (see Figure A).
  3. Clean the top of the SYMLIN (pramlintide acetate injection) vial with an alcohol swab.
  4. Prepare and inject your dose - illustration 1

  5. Pull the plunger of the syringe to the line that matches your SYMLIN (pramlintide acetate injection) dose (see SYMLIN (pramlintide acetate injection) Dosing Chart and Figure B). The amount of air in the syringe should equal the amount of SYMLIN (pramlintide acetate injection) you plan to take.
  6. Prepare and inject your dose - illustration 2

  7. Push the needle through the center of the rubber top of the SYMLIN (pramlintide acetate injection) vial (see Figure C).
  8. Push the plunger to inject the air into the vial.
  9. Prepare and inject your dose - illustration 3

  10. Turn the vial and syringe upside down.
  11. Slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose (see Figure D).
  12. BEFORE removing the syringe from the vial, look for air bubbles inside the syringe. If you see bubbles, push the SYMLIN (pramlintide acetate injection) back into the vial. Then slowly pull the plunger down to draw the SYMLIN (pramlintide acetate injection) into the syringe until you have your correct dose.
  13. Prepare and inject your dose - illustration 4

  14. Check to be sure your dose is correct, then remove the syringe from the vial.
  15. Give your injection as directed by your healthcare provider.
  16. Dispose of the used syringe as directed by your healthcare provider.

Care and Storage

  • Store SYMLIN (pramlintide acetate injection) that has not been opened in the refrigerator, between 36°F to 46°F (2°C to 8°C), until you are ready to use it. Protect SYMLIN (pramlintide acetate injection) from light.
  • After a vial has been used for the first time, it can be refrigerated or kept at a temperature up to 86°F (30°C) for 30 days. Do not leave above 86°F (30°C).
  • Any vial in use should be thrown away after 30 days, even if it still has medicine in it.
  • Unused SYMLIN (pramlintide acetate injection) (opened or unopened) should not be used after the expiration (EXP) date printed on the carton and the label.
  • Do not freeze SYMLIN (pramlintide acetate injection) . Do not use SYMLIN (pramlintide acetate injection) if it has been frozen.
  • Keep SYMLIN (pramlintide acetate injection) and all medicines out of the reach of children

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .
  • Never mix SYMLIN (pramlintide acetate injection) and insulin. Use different syringes for SYMLIN (pramlintide acetate injection) and insulin. Insulin can affect SYMLIN (pramlintide acetate injection) when the two are mixed together.
  • Your prescription may be written in micrograms, and your insulin syringe is labeled in units. Use the chart below to convert micrograms to units.

SYMLIN Dosing Chart
Find Your Dose in Micrograms (meg) Draw Up This Amount in U-100 Insulin Syringe (Units)
15 mcg 2½ units
30 mcg 5 units
45 mcg 7½ units
60 mcg 10 units
120 mcg 20 units

Pen Parts - illustration

Symlin (pramlintide acetate injection) Pen™ 60 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach Pen Needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New Pen Setup - illustration

Routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 15•30•45•60 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 6 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.
    You must see line, arrow, and number on Dose Check (see Figure C).
  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toil free at 1-800-349-8919.

Pen parts - illustration

Symlin (pramlintide acetate injection) Pen™ 120 Pen-Injector Patient Instructions for Use
Read the Medication Guide first

Attach pen needle - illustration

Important Notes

  • Ask your doctor about your dose, injection technique, and needle size.
  • Pen may look empty because SYMLIN (pramlintide acetate injection) is a clear, colorless liquid.
  • Small bubbles will not harm you or affect your dose.
  • DO NOT TRANSFER YOUR SYMLIN (pramlintide acetate injection) FROM THE PEN TO A SYRINGE. This could result in a higher dose than intended, because the SYMLIN (pramlintide acetate injection) in the Pen is a different strength than the SYMLIN (pramlintide acetate injection) in the vial.

New pen setup - illustration

routine use - illustration

Symlin (pramlintide acetate injection) Pen™ pen-injector (Pen)

Read these instructions carefully before using your Pen. Failure to follow these instructions may cause an incorrect dose, a broken Pen, or an infection.

  • Check Pen label before each use to make sure you have the 60•120 mcg Pen.
  • Check the expiration date (EXP) on the Pen label (see Pen Parts), and make sure the Pen is not expired.
  • If you drop your Pen, go to New Pen Setup to confirm Pen works.
  • If any part of your Pen appears broken or damaged, do not use.
  • This Pen is not recommended for use by blind or visually impaired persons without the assistance of a person trained in the proper use of this Pen.
  • If SYMLIN (pramlintide acetate injection) in the Cartridge (see Pen Parts) is not clear, colorless, and free of particles, do not use Pen.

Needles

  • Use a new needle for each injection. Remove the needle from the Pen after completing each injection. This will help prevent leakage of SYMLIN (pramlintide acetate injection) , keep out air bubbles, reduce needle clogs, and reduce risk of infection.
  • Pen needles are not included with the Pen. Use 29, 30, or 31 gauge disposable needles with the Pen. Ask your healthcare provider which needle gauge and length is best for you.
  • Do not share your Pen or needles with anyone.
  • Be sure the needle is completely attached to the Pen before use (see Attach Pen Needle). Do not push the Knob unless a needle is attached to Pen.
  • Throw away used needles in a puncture-resistant container or as directed by your healthcare provider. Do not throw away the Pen with a needle attached.
  • Follow local or institutional policies regarding needle handling and disposal.

Care and Storage

  • Pen that has never been used:
    -Refrigerate (36°F to 46°F, 2°C to 8°C).
    -Protect from light.
    -Do not freeze. Do not use a Pen that has been frozen.
  • Pen in use:
    -After the Pen is used for the first time (first use), refrigerate or keep at a temperature up to 86°F (30°C) for 30 days. Throw away Pen 30 days after first use, even if it still has SYMLIN (pramlintide acetate injection) in it.
  • Pen should not be used after the expiration (EXP) date printed on the label.
  • Do not store Pen with needle attached, or with Knob pulled out.
  • If needed, wipe only the outside of Pen with a clean, damp cloth (water only).
  • White particles may appear where the needle attaches during normal use. You may remove the particles with an alcohol wipe or alcohol swab.
  • Keep Pen and needles out of the reach of children.

About SYMLIN (pramlintide acetate injection)

  • The way you inject SYMLIN (pramlintide acetate injection) is similar to the way you inject insulin. Inject SYMLIN (pramlintide acetate injection) under the skin (subcutaneously) of your stomach area (abdomen) or upper leg (thigh). Inject SYMLIN (pramlintide acetate injection) at a site that is more than 2 inches away from your insulin injection. To help reduce the chances of getting a reaction at the injection site, allow SYMLIN (pramlintide acetate injection) to come to room temperature before injecting. Also, use a new needle for each SYMLIN (pramlintide acetate injection) injection.
  • If you take more than your prescribed dose of SYMLIN (pramlintide acetate injection) , you may get nauseous or vomit, and you may not be able to eat the amount of food you usually eat. Pay careful attention to the amount of insulin you use at this time as you may be at more risk for low blood sugar. Contact your doctor for guidance.
  • If you miss or forget a dose of SYMLIN (pramlintide acetate injection) , wait until the next meal and take your usual dose of SYMLIN (pramlintide acetate injection) at that meal. Do not take more than your usual dose of SYMLIN (pramlintide acetate injection) .

Questions and Answers (Q&A)

Why does my new Pen look empty?

  • Because SYMLIN (pramlintide acetate injection) is clear and colorless, the Cartridge (see Pen Parts) may look empty, even though there is medicine in it.
  • To be sure there is SYMLIN (pramlintide acetate injection) in the Cartridge, perform Pen setup (see New Pen Setup).

What should I do if I see air bubbles?

  • The Cartridge may contain small air bubbles. Small air bubbles are normal and will not harm you or affect your dose.
  • Perform New Pen Setup before the first dose with each new Pen (see New Pen Setup).
  • To prevent more air bubbles, do NOT store Pen with needle attached.

Why can't I turn the Dial?

  • If the Knob has been pulled out, the Dial will not move and you cannot reset your dose. Push in the Knob to discard the dose and repeat the instructions (see Routine Use).
  • If the Knob is pushed in all the way, and you cannot rotate the Dial, call Amylin Customer Support.

What should I do if I do not see a stream of liquid when I perform the setup?

  • Watch for a stream when you start to push the Knob.
  • The liquid is clear and colorless, so it may be difficult to see.
  • Pull out the Knob all the way - you will hear clicking.
  • Firmly push in the Knob all the way- you will hear clicking.
  • If there is no stream of liquid after 3 attempts, replace the needle and repeat setup.
  • If still no stream, call Amylin Customer Support.

What should I do if I load an incorrect dose?

  • Do not inject an incorrect dose. Point the needle away from you and discard the dose by pushing in the Knob all the way. Dial your correct dose.

How do I make sure I am getting my correct dose of SYMLIN (pramlintide acetate injection) ?

  • Before pulling out Knob, be sure the number in Window matches your prescribed SYMLIN (pramlintide acetate injection) dose (see Figure A).
  • Pull out the Knob all the way - you will hear clicking (see Figure B).
  • Be sure that number on the Dose Check matches your dose in Window.

You must see line, arrow, and number on Dose Check (see Figure C).

  • Firmly push in the Knob all the way - you will hear clicking.
  • Hold Knob for 10 seconds before removing needle from skin (see Figure E).

Why do I see SYMLIN (pramlintide acetate injection) leaking from my needle after I inject?

  • You may see one or two drops
    - this is normal.
  • If you see more than 2 drops:
    -You may not have received your full dose.
    -Do not inject another dose.
    -Talk to your healthcare provider.
  • To prevent dripping or leaking, be sure to firmly push and hold Knob with your thumb for 10 seconds before removing needle from skin.

How do I know when my pen is empty?

  • Check Your Dose after pulling out the Knob (see Figure C).
  • The lines on the Cartridge show approximately how much SYMLIN (pramlintide acetate injection) is left in the Pen. When the Plunger is at the thickest line on the Cartridge, your Pen is almost empty (see Figure F).

How to know when the pen is empty - illustration 1

  • If you cannot see the line, arrow, and number that match your prescribed dose, you do not have enough SYMLIN (pramlintide acetate injection) to give your full dose (see Figure H). Throw away this Pen, and use a new Pen to give your dose.

How to know when the pen is empty - illustration 2

The Patient Instructions for Use do not take the place of talking with your doctor about your diabetes treatment. Ask your doctor about your dose and preferred injection technique. If you are having problems using your Pen, please visit www.SYMLIN (pramlintide acetate injection) .com or call Amylin Customer Support toll free at 1 -800-349-8919.

Last reviewed on RxList: 4/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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