albiglutide

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Pronunciation: AL bi GLOO tide

Brand: Tanzeum

What is the most important information I should know about albiglutide?

You should not use albiglutide if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer). Do not use albiglutide if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

In animal studies, albiglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

What is albiglutide?

Albiglutide is an injectable diabetes medicine that helps control blood sugar levels.

Albiglutide is used together with diet and exercise to treat type 2 diabetes. Albiglutide is usually given after other diabetes medications have been tried without success.

This medicine is not for treating type 1 diabetes.

Albiglutide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using albiglutide?

You should not use albiglutide if you are allergic to it, or if you have:

  • an endocrine system cancer called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
  • a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or
  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

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

  • pancreatitis;
  • stomach disorder such as slowed digestion;
  • an intestinal disorder;
  • liver or kidney disease;
  • if you also use insulin or oral diabetes medicine; or
  • if you have been sick with vomiting or diarrhea.

In animal studies, albiglutide caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Using albiglutide during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant. If you plan to get pregnant, you should stop using this medicine for at least 1 month before conception. Do not stop using albiglutide without asking your doctor about using a different medicine to treat your diabetes.

It is not known whether albiglutide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to anyone under 18 years old without medical advice.

How should I use albiglutide?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Albiglutide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Albiglutide is injected under the skin. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

You may use albiglutide with or without food.

The albiglutide prefilled injection pen comes in a strength of 30 milligrams (mg) or 50 mg. The pen contains powder medicine and a liquid that must be mixed before you give the injection. Each pen strength has a certain "wait" time to allow the powder to completely dissolve after mixing. The 30-mg pen needs 15 minutes of wait time, and the 50-mg pen needs 30 minutes of wait time Mixed medicine must be used within 8 hours.

If you are using the injections at home, be sure you understand how to properly mix the medicine. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not mix albiglutide together with insulin in the same injection.

Albiglutide is usually given only one time per week. Use the medicine on the same day each week if possible. Allow at least 4 days to pass between doses.

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

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

Each single-use injection pen is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. 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.

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.

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.

Storing unopened injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any albiglutide not used before the expiration date on the medicine label.

You may also store injection pens at room temperature, away from moisture and heat, for up to 4 weeks before use.

Do not freeze albiglutide, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If you are more than 3 days late, skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe nausea and vomiting.

What should I avoid while using albiglutide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of albiglutide?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • signs of a thyroid tumor --swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;
  • low blood sugar --headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or
  • signs of a kidney problem --little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • nausea, diarrhea;
  • cough, cold or flu symptoms;
  • back pain; or
  • pain, swelling, or irritation where medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect albiglutide?

Other drugs may interact with albiglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about albiglutide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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