Pramlintide injection (patient information)

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, and if you needed medical treatment for hypoglycemia several times in the past 6 months. 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 (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clonidine (Catapres); disopyramide (Norpace); fenofibrate (Lofibra, Tricor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); other medications for diabetes; monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate); pentoxifylline (Trental); propoxyphene (Darvon); reserpine (Serpalan, Serpasil); 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 an upset stomach 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 medication 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.

How should this medicine be used

Pramlintide comes as a solution (liquid) 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.

Use a U-100 insulin syringe to inject pramlintide. It is best to use the 0.3-mL size. Use the table in the medication guide to find the number of insulin syringe units that matches your prescribed dose (in micrograms [mcg]) of pramlintide. Ask your doctor or pharmacist if you are not sure how many syringe units of medication you will need to inject.

Use a new syringe and needle for each injection. Do not mix pramlintide and insulin in the same syringe, and do not use the same syringe or needle to inject pramlintide and insulin one after another. Throw away your needle and syringe in a puncture-resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to throw away 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 vial of pramlintide to warm to room temperature before you inject the medication. Look at the liquid in the vial before you inject it, and do not use it if it is cloudy. If you have questions about injecting pramlintide, ask your doctor or pharmacist.

Other uses for this medicine

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

What special precautions should I follow

Before using pramlintide:

• tell your doctor and pharmacist if you are allergic to pramlintide, any other medications, or metacresol.
• 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: antihistamines; 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; cisapride (Propulsid); laxatives; metoclopramide (Reglan); 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 a medication for pain such as acetaminophen (Tylenol), take it at least 1 hour before or 2 hours after you use pramlintide.
• tell your doctor if you have or have ever had gastroparesis (slowed movement of food from the stomach to the small intestine) and if you are being treated with dialysis (treatment to clean the blood outside the body when the kidneys are not working well).
• 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.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using pramlintide.

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 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.

Side effects

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 in the place where you injected pramlintide
• loss of appetite
• stomach pain
• indigestion
• upset stomach
• excessive tiredness
• dizziness
• coughing
• 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 [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep unopened vials of pramlintide in the refrigerator, but do not freeze them. Throw away any vials that were frozen or exposed to heat. You may store opened vials of pramlintide in the refrigerator or at room temperature, and you must use them within 28 days. Throw away any medication left in an opened vial after 28 days and any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local 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.

Brand names

• Symlin®