Pramlintide Injection

Brand Name(s): Symlin Pen^®

IMPORTANT WARNING:

You will use pramlintide with mealtime insulin to control your blood sugar levels. When you use insulin, there is a chance that you will experience hypoglycemia (low blood sugar). This risk may be greater during the first 3 hours after you inject pramlintide, especially if you have type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). You may harm yourself or others if your blood sugar drops while you are involved in an activity that requires you to be alert or to think clearly. Do not drive a car or use heavy machinery until you know how pramlintide affects your blood sugar. Talk to your doctor about what other activities you should avoid while you are using pramlintide.

Tell your doctor if you have had diabetes for a long time, if you have diabetic nerve disease, if you cannot tell when your blood sugar is low, if you needed medical treatment for hypoglycemia several times in the past 6 months, or if you have gastroparesis (slowed movement of food from the stomach to the small intestine. Your doctor will probably tell you not to use pramlintide. Also tell your doctor if you are taking any of the following medications: angiotensin converting enzyme (ACE) inhibitors used to treat high blood pressure, heart disease, or diabetic kidney disease; beta blockers such as atenolol (in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol, in Lopressor HCT), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran, in Inderide); clonidine (Catapres, Duraclon, Kapvay, in Clorpres); disopyramide (Norpace); fenofibrate (Antara, Lipofen, Tricor, others); fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax); gemfibrozil (Lopid); guanethidine (Ismelin; no longer available in U.S.); other medications for diabetes; lanreotide (Somatuline Depot); monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); pentoxifylline (Pentoxil); propoxyphene (Darvon; no longer available in U.S.); reserpine; salicylate pain relievers such as aspirin; and sulfonamide antibiotics such as trimethoprim/sulfamethoxazole (Bactrim, Septra).

While you are using pramlintide, you must measure your blood sugar before and after every meal and at bedtime. You also will need to see or talk to your doctor often, and frequently change your doses of pramlintide and insulin according to your doctor's directions. Tell your doctor if you think that it will be difficult for you to do these things, if you have had difficulty checking your blood sugar or using your insulin correctly in the past, or if you find it difficult to manage your treatment after you start using pramlintide.

Your doctor will decrease your dose of insulin when you start using pramlintide. Your doctor will start you on a low dose of pramlintide and will gradually increase your dose. Call your doctor right away if you have nausea during this time; your dose may need to be changed or you may have to stop using pramlintide. Your doctor will probably change your dose of insulin once you are using a dose of pramlintide that is right for you. Follow all of these directions carefully and ask your doctor or pharmacist right away if you are not sure how much insulin or pramlintide you should use.

The risk of hypoglycemia may be greater in certain situations. Call your doctor if you plan to be more active than usual. If you have any of the following conditions you should not use pramlintide and should call your doctor to find out what to do:

• you plan to skip a meal.
• you plan to eat a meal with less than 250 calories or 30 grams of carbohydrates.
• you cannot eat because you are sick.
• you cannot eat because you are scheduled for surgery or a medical test.
• your blood sugar is very low before a meal.

Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using pramlintide.

Call your doctor right away if your blood sugar is lower than normal or if you have any of the following symptoms of low blood sugar: hunger, headache, sweating, shaking of a part of your body that you cannot control, irritability, difficulty concentrating, loss of consciousness, coma, or a seizure. Be sure that you always have a fast acting source of sugar such as hard candy, juice, glucose tablets, or glucagon available to treat hypoglycemia.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pramlintide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov.

WHY is this medicine prescribed?

Pramlintide is used with mealtime insulin to control blood sugar levels in people who have diabetes. Pramlintide is only used to treat patients whose blood sugar could not be controlled by insulin or insulin and an oral medication for diabetes. Pramlintide is in a class of medications called antihyperglycemics. It works by slowing the movement of food through the stomach. This prevents blood sugar from rising too high after a meal, and may decrease appetite and cause weight loss.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Pramlintide comes as a solution (liquid) in a prefilled dosing pen to inject subcutaneously (just under the skin). It is usually injected several times a day, before each meal that includes at least 250 calories or 30 grams of carbohydrate. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use pramlintide exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Pramlintide controls diabetes but does not cure it. Continue to use pramlintide even if you feel well. Do not stop using pramlintide without talking to your doctor. If you do stop using pramlintide for any reason, do not start using it again without talking to your doctor.

Be sure you know what other supplies, such as needles, you will need to inject your medication. Ask your doctor or pharmacist what type of needles you will need to inject your medication. Carefully read and understand the manufacturer's instructions for injecting pramlintide using the pen. Also make sure you know how and when to set up a new pen. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully. Do not mix pramlintide with insulin.

Always look at your pramlintide pen solution before you inject it. It should be clear and colorless. Do not use pramlintide if it is colored, cloudy, thickened, contains solid particles, or if the expiration date on the package label has passed.

Never reuse needles and never share needles or pens. Always remove the needle right after you inject your dose. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

You can inject pramlintide anywhere on your stomach or thigh. Do not inject pramlintide into your arm. Choose a different spot to inject pramlintide every day. Be sure that the spot you choose is more than 2 inches away from the spot where you will inject insulin.

You should inject pramlintide under the skin the same way that you inject insulin. Allow the pramlintide pen to warm to room temperature before you inject the medication. If you have questions about injecting pramlintide, ask your doctor or pharmacist.

What SPECIAL PRECAUTIONS should I follow?

Before using pramlintide injection,

• tell your doctor and pharmacist if you are allergic to pramlintide, any other medications, metacresol, or any other ingredients in the pramlintide pen. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: acarbose (Precose); antihistamines; atropine (Atropen, in Lomotil, others); certain antidepressants ('mood elevators') called tricyclic antidepressants; certain medications to treat asthma, diarrhea, lung disease, mental illness, motion sickness, overactive bladder, pain, Parkinson's disease, stomach or intestinal cramps, ulcers, and upset stomach; laxatives;miglitol (Glyset); and stool softeners. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are taking oral contraceptives (birth control pills), pain medications, or antibiotics, take them at least 1 hour before or 2 hours after you use pramlintide.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using pramlintide, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Your doctor, dietitian, or diabetes educator will help you create a meal plan that works for you. Follow the meal plan carefully.

What should I do IF I FORGET to take a dose?

Skip the missed dose and use your usual dose of pramlintide before your next major meal. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Pramlintide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, bruising, or itching at the pramlintide injection site
• loss of appetite
• stomach pain
• excessive tiredness
• dizziness
• cough
• sore throat
• joint pain

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING section, call your doctor immediately.

Pramlintide may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store unopened pramlintide pens in the refrigerator and protect from light; do not freeze the pens. Dispose of any pens that were frozen or exposed to heat. You may store opened pramlintide pens in the refrigerator or at room temperature, but you must use them within 30 days. Dispose of any opened pramlintide pens after 30 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vomiting
• diarrhea
• dizziness
• flushing

What OTHER INFORMATION should I know?

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.