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Tanzeum

Generic Name: albiglutide (AL bi GLOO tide)
Brand Names: Tanzeum

What is Tanzeum?

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

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

This medicine is not for treating type 1 diabetes.

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

Important information

You should not use Tanzeum 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 Tanzeum if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Slideshow: Flashback: FDA Drug Approvals 2013

In animal studies, Tanzeum 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.

Before taking this medicine

You should not use Tanzeum if you are allergic to albiglutide, 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 Tanzeum 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, Tanzeum 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.

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

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Tanzeum.

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

How should I use Tanzeum?

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

Tanzeum 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 Tanzeum with or without food.

Tanzeum is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Mixed medicine must be used within 8 hours.

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

Tanzeum 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 Tanzeum 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 Tanzeum, and throw away the medication if it has become frozen.

Tanzeum dosing information

Usual Adult Dose for Diabetes Type 2:

Initial dose: 30 mg subcutaneously once a week, on the same day each week

May be increased to 50 mg subcutaneously once a week if glycemic response is inadequate.

Comments: The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.

Use: Adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

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 Tanzeum?

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

Tanzeum side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Tanzeum: 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 Tanzeum 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.

See also: Side effects (in more detail)

What other drugs will affect Tanzeum?

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 Tanzeum.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this Tanzeum only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2014-05-15, 9:09:10 AM.

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