SymlinPen 60

You should not use this medicine if you are allergic to pramlintide or metacresol, or:

• if you have a digestive condition called "delayed gastric emptying"; or

• if you cannot recognize symptoms of low blood sugar.

To make sure pramlintide is safe for you, tell your doctor if you have:

• a history of delayed gastric emptying;

• problems with vision (blindness, trouble reading);

• if you are unable to check your blood sugars regularly; or

• if you have had severe hypoglycemia more than once in the past 6 months.

It is not known whether pramlintide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether pramlintide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Pramlintide should not be used in children.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. When you first start using pramlintide, your insulin dose will change. Do not use your medicines in larger or smaller amounts or for longer than recommended.

Pramlintide is injected under the skin, at the same time as your insulin injection but in a separate injection. Do not self-inject your medicines if you do not fully understand how to give the injections and properly dispose of used needles and syringes.

Do not mix pramlintide and insulin together in the same syringe.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Pramlintide is usually given just before each major meal. If you skip a meal, you should also skip your pramlintide dose.

Use a different place on your stomach or thigh each time you give the injection. Inject your insulin in a separate skin area. Do not inject insulin or pramlintide into the same place two times in a row.

Do not use pramlintide if it has changed colors or looks cloudy. Call your pharmacist for new medication.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

Take care not to let your blood sugar get too low. Severely low blood sugar (hypoglycemia) may occur within 3 hours after your pramlintide injection. If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Never share an injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.

Call your doctor if you have severe nausea that lasts for several days. This may be a sign that your dose is too high.

Pramlintide is only part of a treatment program that also includes diet, exercise, weight control, regular blood sugar testing, and special medical care. Keep a regular schedule when using your injections and testing your blood sugar. It is also important to plan your meals and physical activity. You may not be able to keep using pramlintide if you do not follow the dosing instructions.

If you stop using pramlintide for a short time, you may need to restart the medicine at a lower dose. Follow your doctor's instructions.

Storing unopened injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any pramlintide not used before the expiration date on the medicine label. Do not freeze pramlintide, and throw away the medication if it has become frozen.

Take an injection pen out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not remove pramlintide from an injector pen and put the medicine in a syringe. You may receive too high a dose.

Storing after your first use: You may keep "in-use" injection pens in the refrigerator or at room temperature. Use within 30 days.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose may cause diarrhea, vomiting, dizziness, cold sweats, warmth or tingly feeling.

• If you have an allergy to pramlintide or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have slow stomach clearing.
• If you cannot tell when your blood sugar is low.
• If you are taking any of these drugs: Acarbose or atropine.

This is not a list of all drugs or health problems that interact with SymlinPen 60.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seizures.
• Very upset stomach or throwing up.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Not hungry.
• Irritation or swelling where the shot was given.
• Upset stomach or throwing up.
• Belly pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time SymlinPen 60 is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take SymlinPen 60 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to SymlinPen 60. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to pramlintide: subcutaneous solution

Along with its needed effects, pramlintide (the active ingredient contained in SymlinPen 60) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pramlintide:

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool pale skin
• cough
• depression
• difficulty with swallowing
• dizziness
• fast heartbeat
• headache
• hives, itching, or skin rash
• increased hunger
• nausea
• nightmares
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness
• slurred speech
• tightness in the chest
• unusual tiredness or weakness

Some side effects of pramlintide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• inflicted injury
• loss of appetite
• muscle pain or stiffness
• pain in the joints
• stomach pain
• vomiting
• weight loss

• Body aches or pain
• congestion
• dryness or soreness of the throat
• fever
• hoarseness
• runny nose
• tender, swollen glands in the neck
• voice changes