SymlinPen 120 2,700 mcg/2.7 mL subcutaneous pen injector

Generic name:
Pramlintide - injection

Pronunciation
(PRAM-lin-tide)

Brand name(s)
Symlinpen

Pramlintide may increase the risk of very low blood sugar when used with insulin, particularly in patients with type 1 diabetes. This reaction is most likely to occur within 3 hours after an injection. Your doctor may decrease your insulin dose when you start pramlintide. Low blood sugar makes it hard to think clearly, drive a car, use heavy machinery, or safely participate in other activities that include a risk of hurting yourself or others. (See also Side Effects and Precautions sections.)

Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Pramlintide acts like a certain natural substance called amylin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach. It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need.

This medication should not be used by people who are unable to tell when they have symptoms of low blood sugar (such as children).

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using pramlintide and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, consult your doctor or pharmacist.

Inject this medication under the skin just before each main meal. Do not use pramlintide if your blood sugar is too low, if you are planning to eat a small meal (less than 250 calories or 30 grams of carbohydrate), or if you are skipping a meal. The injection is given in the thigh or abdomen. The dosage is based on your medical condition and response to treatment. To reduce the risk of nausea, your doctor may direct you to start at a low dose of pramlintide and gradually increase the dose. Your doctor may also direct you to lower your insulin dose and to check your blood sugar more often. Do not change your dosage without consulting your doctor.

If the medication is in the refrigerator, take the medication out of the refrigerator and allow it to reach room temperature before you inject it. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Never mix pramlintide and insulin in the same syringe or at the same injection site. Inject pramlintide in an area that is at least 2 inches (5 centimeters) away from your insulin injection site. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly in order to get the most benefit from it.

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

Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

Nausea, vomiting, tiredness, and upset stomach may occur as your body adjusts to the medication. Nausea can be reduced by starting at a low dose and increasing the dose slowly. Redness, swelling and itching at the injection site may occur and usually go away in a few days. If any of these effects last or get worse, contact your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Though pramlintide does not cause low blood sugar (hypoglycemia) by itself, this effect can occur because it is used with insulin. This may also occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using pramlintide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative metacresol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using pramlintide, tell your doctor or pharmacist your medical history, especially of:

• stomach/intestinal disorders (for example, digestion problems such as gastroparesis)
• attacks of low blood sugar (hypoglycemia) that required treatment

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages because alcohol can affect your blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if pramlintide passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• diabetes drugs (including alpha glucosidase inhibitors such as acarbose/miglitol)
• darifenacin
• drugs for high blood pressure that may make it harder to notice symptoms of low blood sugar (such as clonidine, guanethidine)
• drugs that slow down or speed up movement of food through your stomach (causing constipation or diarrhea; drugs such as atropine, exenatide, metoclopramide)
• solifenacin

Some other medications may not work as well if used at the same time as pramlintide. Affected products include antibiotics, birth control pills, pain relievers (such as acetaminophen), among others. If you are using any of the those drugs, use them at least 1 hour before or 2 hours after your injection. If you have any questions about when to take your other medications, ask your pharmacist.

If you are using a medication that needs to be taken with food, take it with a small meal or snack (less than 250 calories or 30 grams of carbohydrate) at a time when you do not normally inject pramlintide.

Beta blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe nausea, vomiting, diarrhea, flushing, dizziness.

Do not share this medication, syringes, or needles with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Lab and/or medical tests (such as fasting blood glucose, hemoglobin A1c) should be done while you are using this medication. Keep all medical and lab appointments. Check your blood sugar regularly as directed (usually before and after meals and at bedtime) and share the results with your doctor.

If you miss a dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store unused injectors in the refrigerator away from light. Do not freeze. Do not use this medication if it has been frozen. Once used, this product may be stored in the refrigerator or at room temperature. Discard the used injector after 30 days. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.