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Albiglutide Injection

(al'' bi gloo' tide)

Brand Name(s): Tanzeum®

IMPORTANT WARNING:

Albiglutide injection may increase the risk that you will develop tumors of the thyroid gland, including medullary thyroid carcinoma (MTC; a type of thyroid cancer). Laboratory animals who were given medications similar to albiglutide developed tumors, but it is not known if these medications increase the risk of tumors in humans. Tell your doctor if you or anyone in your family has or has ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2; condition that causes tumors in more than one gland in the body). If so, your doctor will probably tell you not to use albiglutide injection. If you experience any of the following symptoms, call your doctor immediately: a lump or swelling in the neck; hoarseness; difficulty swallowing; or shortness of breath.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to albiglutide injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with albiglutide injection 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 visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using albiglutide injection.

IMPORTANT NOTICE:

Albiglutide injection will no longer be available in the United States after July 2018. If you are currently using albiglutide injection, you should call your doctor to discuss switching to another treatment.

WHY is this medicine prescribed?

Albiglutide injection is used with a diet and exercise program to control blood sugar levels in adults with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications did not control levels well enough. Albiglutide injection is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Albiglutide injection is in a class of medications called incretin mimetics. It works by helping the pancreas to release the right amount of insulin when blood sugar levels are high. Insulin helps move sugar from the blood into other body tissues where it is used for energy. Albiglutide injection also works by slowing the movement of food through the stomach.

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?

Albiglutide injection comes as a powder to be mixed with water in a prefilled dosing pen to inject subcutaneously (under the skin). It is usually injected once a week without regard to meals. Use albiglutide injection on the same day each week at any time of day. You may change the day of the week that you use albiglutide as long as it has been 4 or more days since you used your last dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use albiglutide injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Albiglutide injection controls diabetes but does not cure it. Continue to use albiglutide injection even if you feel well. Do not stop using albiglutide injection without talking to your doctor.

Albiglutide comes in prefilled dosing pens that contain enough medication for one dose. Always inject albiglutide in its own prefilled dosing pen; never mix it with any other medication.

Carefully read the manufacturer's instructions for use that come with the medication. These instructions describe how to prepare and inject a dose of albiglutide injection. Be sure to ask your pharmacist or doctor if you have any questions about how to prepare or inject this medication.

Always look at your albiglutide before you inject it. It should be clear, yellow, and free of solid particles.

You can inject your albiglutide in your upper arm, thigh, or stomach area. Never inject albiglutide into a vein or muscle. Change (rotate) the injection site within the chosen area with each dose. You can inject albiglutide and insulin in the same body area, but you should not give the injections right next to each other.

Never reuse or share needles or pens. Always use a new needle for each injection. Dispose of needles in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture resistant container.

What SPECIAL PRECAUTIONS should I follow?

Before using albiglutide injection,

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

  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. It is especially important to tell your doctor about all the medications you take by mouth because albiglutide may change the way your body absorbs these medications. Also be sure to mention insulin or oral medications for diabetes especially sulfonylureas, including chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase, in Glucovance), tolazamide, and tolbutamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

  • tell your doctor if you have or have ever had pancreatitis (inflammation of the pancreas); severe stomach problems, including gastroparesis (slowed movement of food from the stomach to the small intestine) or problems digesting food; or kidney or liver disease.

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

  • ask your doctor what to do if you get sick, develop an infection or fever, or experience unusual stress. These conditions can affect your blood sugar and the amount of albiglutide you may need.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian.

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

Use the missed dose as soon as you remember it. However, if it is more than 3 days after the missed dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

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

  • diarrhea
  • nausea
  • heartburn
  • redness, swelling, or itching at the site of the injection
  • cough or flu-like symptoms

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using albiglutide injection and call your doctor immediately or get emergency medical treatment:

  • ongoing pain that begins in the upper left or middle of the stomach but may spread to the back
  • vomiting
  • hives
  • rash
  • itching
  • difficulty breathing

Albiglutide injection 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 it at room temperature for up to 4 weeks before using or in the refrigerator, and away from excess heat and moisture (not in the bathroom). Do not freeze.

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:

  • severe nausea and vomiting

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.

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