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

Tanzeum is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Tanzeum is usually given after other diabetes medications have been tried without success. It is not for treating type 1 diabetes.

You should not use Tanzeum if you have multiple endocrine neoplasia type 2 (tumors in your glands), a personal or family history of medullary thyroid cancer, insulin-dependent diabetes, or diabetic ketoacidosis.

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.

Before taking this medicine

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

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Tanzeum is safe for you, tell your doctor if you have ever had:

• a stomach or intestinal disorder;

• pancreatitis; or

• liver or kidney disease.

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.

Albiglutide may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tanzeum can have long-lasting effects on your body. Avoid getting pregnant for at least 1 month after you stop using this medicine.

You should not breastfeed while using Tanzeum.

Tanzeum is not approved for use by anyone younger than 18 years old.

Use Tanzeum exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Tanzeum is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has particles in it. Call your pharmacist for new medicine.

The prefilled injection pen contains a powder and a liquid that must be mixed before using the pen. Each different pen strength has a certain "wait" time to allow the powder to completely dissolve after mixing: 15 minutes for a 30-mg pen and 30 minutes for a 50-mg pen.

Tanzeum is usually given once per week at any time of the day, with or without a meal. If you want to change your weekly injection day, wait at least 4 days after your most recent injection before giving another one.

Drink plenty of liquids to keep your kidneys working properly.

Your healthcare provider will show you where on your body to inject Tanzeum. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Tanzeum. This can lead to kidney failure.

Store injection pens in their original carton in a refrigerator. Do not freeze Tanzeum, and throw away the medication if it has become frozen. Throw away any pens not used before the expiration date.

You may also store the pens at room temperature for up to 4 weeks before use.

Use an injection pen only once and then place it in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 30 mg subcutaneously once a week
-If glycemic response is inadequate, may increase to 50 mg subcutaneously once a week
Maintenance dose: 30 or 50 mg subcutaneously once a week

Comments:
-This drug is not recommended as first-line therapy because of uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk.
-This drug has not been studied in patients with a history of pancreatitis; consider alternative therapies
-The dose of concomitantly administered insulin or insulin secretagogues may need to be reduced when starting therapy in order to decrease the risk of hypoglycemia.
-This drug has not been studied in combination with prandial insulin.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

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

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Tanzeum is safe for you, tell your doctor if you have ever had:

• a stomach or intestinal disorder;

• pancreatitis; or

• liver or kidney disease.

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.

Albiglutide may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tanzeum can have long-lasting effects on your body. Avoid getting pregnant for at least 1 month after you stop using this medicine.

You should not breastfeed while using Tanzeum.

Tanzeum is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 3 days late for the dose. Do not use two doses within 3 days of each other.

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

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Get emergency medical help if you have signs of an allergic reaction to Tanzeum: hives; fast heartbeats, feeling light-headed; 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

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Common Tanzeum side effects may include:

• nausea, diarrhea;

• cough, cold or flu symptoms;

• back pain, joint 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• insulin; or

• oral diabetes medications.

This list is not complete. Other drugs may interact with albiglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.