What is this medication?

ALBIGLUTIDE (al bi GLOO tide) is used to improve blood sugar control in adults with type 2 diabetes. This medicine may be used with other oral diabetes medicines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tanzeum

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• endocrine tumors (MEN 2) or if someone in your family had these tumors
• history of pancreatitis
• kidney disease
• liver disease
• stomach problems
• thyroid cancer or if someone in your family had thyroid cancer
• an unusual or allergic reaction to albiglutide, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin of your upper leg (thigh), stomach area, or upper arm. It is usually given once every week (every 7 days). You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take it more often than directed.

If you use this medicine with insulin, you should inject this medicine and the insulin separately. Do not mix them together. Do not give the injections right next to each other. Change (rotate) injection sites with each injection.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This drug comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this drug. Read the information carefully. Talk to your pharmacist or health care provider if you have questions.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can within 3 days after the missed dose. Then take your next dose at your regular weekly time. If it has been longer than 3 days after the missed dose, do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses. If you have questions about a missed dose, contact your health care provider for advice.

What may interact with this medication?

• other medicines for diabetes

Many medications may cause changes in blood sugar, these include:

• alcohol containing beverages
• antiviral medicines for HIV or AIDS
• aspirin and aspirin-like drugs
• certain medicines for blood pressure, heart disease, irregular heart beat
• chromium
• diuretics
• female hormones, such as estrogens or progestins, birth control pills
• fenofibrate
• gemfibrozil
• isoniazid
• lanreotide
• male hormones or anabolic steroids
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for weight loss
• medicines for allergies, asthma, cold, or cough
• medicines for depression, anxiety, or psychotic disturbances
• niacin
• nicotine
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• octreotide
• pasireotide
• pentamidine
• phenytoin
• probenecid
• quinolone antibiotics such as ciprofloxacin, levofloxacin, ofloxacin
• some herbal dietary supplements
• steroid medicines such as prednisone or cortisone
• sulfamethoxazole; trimethoprim
• thyroid hormones

Some medications can hide the warning symptoms of low blood sugar (hypoglycemia). You may need to monitor your blood sugar more closely if you are taking one of these medications. These include:

• beta-blockers, often used for high blood pressure or heart problems (examples include atenolol, metoprolol, propranolol)
• clonidine
• guanethidine
• reserpine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular checks on your progress.

Drink plenty of fluids while taking this medicine. Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea, and vomiting. The loss of too much body fluid can make it dangerous for you to take this medicine.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Pens should never be shared. Even if the needle is changed, sharing may result in passing of viruses like hepatitis or HIV.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• diarrhea that continues or is severe
• lump or swelling on the neck
• severe nausea
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• trouble swallowing
• unusual stomach upset or pain
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• joint pain
• nausea
• pain, redness, or irritation at site where injected
• stomach upset
• stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store unopened pens in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze or use if the medicine has been frozen. Protect from light and excessive heat. Store in the carton until use. Each single-use pen can be kept at a temperature not to exceed 30 degrees C (86 degrees F) for up to 28 days, if needed. Use an opened pen within 8 hours after mixing the powder with the liquid in the pen. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.