Albiglutide, Injection

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KEY POINTS

• This medicine is given by injection along with diet and exercise to treat type 2 diabetes. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause thyroid tumors or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidiabetic; GLP-1 receptor agonist

Generic and brand names: albiglutide, injection; Tanzeum

What is this medicine used for?

This medicine is given by injection (shots) along with diet and exercise to treat type 2 diabetes when diet and exercise alone have not controlled blood sugar levels. This medicine is not used to treat type 1 diabetes or diabetic ketoacidosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Gastroparesis (slow stomach emptying), problems digesting food, or other intestinal problems
• Liver or kidney problems
• Medullary thyroid carcinoma (MTC) or other thyroid problems
• Multiple endocrine neoplasia syndrome type 2 (MEN 2) (tumors in more than 1 gland in your body)
• Pancreatitis
• Problems with alcohol abuse

Tell your healthcare provider if you currently have an infection or fever. Also tell your provider if you have had surgery recently, or if you are scheduled to have surgery.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is injected under the skin (subcutaneously) of your stomach, upper arm, or thigh once a week, on the same day of the week, with or without food. This medicine should not be mixed with insulin injections. You may give insulin injections in the same area of the body, such as the stomach, but do not give injections of this medicine and insulin right next to each other. Talk with your healthcare provider for specific instructions. Do not stop using this medicine without your healthcare provider's approval.

Check the label on the medicine for directions about your specific dose. Measure your dosage very carefully to avoid an overdose, which can lead to a coma.

This medicine comes in a single use pen. The pen contains a medicine powder in 1 chamber and water in another chamber. Carefully follow the instructions for use included in the package on how to mix the medicine and water and prepare the pen for injection. Your healthcare provider will teach you how to mix and inject this medicine before you use it for the first time. Be sure you know when to take the medicine and how much medicine you should take. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Do not use this medicine if the mixed liquid in the pen looks cloudy or has solid particles. It will have a yellow color which is normal.

Ask your healthcare provider or pharmacist how to dispose of any used needles, syringes, vials, or pens. Never share needles, pens, or delivery devices with anyone else.

What if I miss a dose?

If you miss a dose, take it as soon as you remember within 3 days of the missed dose. After that, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe nausea, vomiting, diarrhea, headache, weakness, dizziness, confusion, flushing, irritability, hunger, fast heartbeat, sweating, tremors.

What should I watch out for?

This medicine may cause thyroid tumors. If you develop a lump in the neck, hoarseness, trouble swallowing, or shortness of breath while taking this medicine, contact your healthcare provider right away.

Follow the diet and exercise program prescribed by your healthcare provider. Eat regular meals and do not skip meals, even when you travel or are sick.

Test your blood sugar on the schedule your provider recommends and keep track of it. See your provider regularly for an A1C test to check the average of your blood sugar over 2 to 3 months. This average is different from your day to day blood sugar. Keep all appointments for these tests.

Low blood sugar (hypoglycemia) can happen if you miss or delay meals, drink too much alcohol, use too much of this medicine or too much insulin, or exercise more than usual. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. Taking glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Alcohol may affect your response to medicine and food. Do not drink alcohol unless your healthcare provider approves.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry an ID card or a Medic Alert bracelet. If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Lump in the neck, hoarseness, trouble swallowing, or shortness of breath; symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness), severe or constant nausea or vomiting; severe stomach pain; severe back pain; trouble passing urine or change in the amount of urine.

Other: Mild nausea, headache, diarrhea, constipation, heartburn, loss of appetite, tiredness, dizziness, injection site redness or rash, cough, mild back pain, joint pain.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), colestipol (Colestid), fenofibrate (Antara, Fenoglide, Lipofen, TriCor, Triglide), and gemfibrozil (Lopid)
• Other diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Psyllium (Take psyllium 2 hours before or 2 hours after you take this medicine.)

This medicine slows stomach emptying and can affect other medicines you take. Talk with your healthcare provider about this if you are taking other medicines.

Many medicines may change how well this medicine controls your blood sugar. Be sure to tell the healthcare provider who prescribed this medicine about any other medicines you are taking, including nonprescription products. Also, tell any other healthcare providers who treat you that you are taking this medicine for diabetes.

Many nonprescription products contain sugar, alcohol, or other ingredients that may interfere with this medicine or increase your blood sugar. Check product labels for warnings for diabetics or ask your healthcare provider or pharmacist for advice.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

It is best to store this medicine in the refrigerator in the original carton it comes in. You may store this medicine at room temperature for up to 1 month before you are ready to use it. Do not let it freeze. Take the medicine out of the refrigerator and allow it to warm to room temperature for 15 minutes before using it.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.