Albiglutide

Albiglutide is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes.

Albiglutide belongs to a group of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These help to normalize blood sugar levels by causing the pancreas to release insulin when blood sugar levels are high.

This medication comes in an injectable form. Albiglutide is given under the skin (subcutaneously), once-weekly, on the same day each week.

Common side effects of albiglutide include diarrhea, nausea, and injection site reactions.

Albiglutide is a prescription medication used to control blood glucose (sugar) in people with type 2 diabetes

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Albiglutide may be found in some form under the following brand names:

• Tanzeum

Serious side effects have been reported with albiglutide. See the “ Albiglutide Precautions” section.

Common side effects of albiglutide include the following:

• diarrhea
• nausea
• injection site reactions

This is not a complete list of albiglutide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Albiglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Albiglutide may affect the way some medicines work and some other medicines may affect the way albiglutide works.

Especially tell your doctor if you take:

• insulin, or any other anti-diabetes medicines
• birth control pills that are taken by mouth (oral contraceptives)
• digoxin Lanoxin)
• warfarin (Coumadin, Jantoven)
• simvastatin (Zocor)

This is not a complete list of albiglutide drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with albiglutide including the following:

• Acute pancreatitis. Tell your healthcare provider right away if you have some or all of the following symptoms of acute pancreatitis:
  • severe pain in your stomach area (abdomen) that will not go away
  • vomiting
  • pain that may go from your abdomen to your back
• Hypoglycemia. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • dizziness or light-headedness
  • sweating
  • confusion
  • headache
  • blurred vision
  • slurred speech
  • shakiness
  • fast heart beat
  • anxiety, irritability, or mood changes
  • hunger
  • feeling jittery

Talk with your healthcare provider about how to treat low blood sugar.

• Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
• Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may result in loss of fluids (dehydration) which may worsen kidney problems.
• Allergic reactions. Stop using albiglutide and get medical help right away if you have any symptoms of an allergic reaction. Do not use albiglutide if you have had an allergic reaction to albiglutide or any of the other ingredients in it. Symptoms of a severe allergic reaction with albiglutide may include:

• swelling of your face, lips, tongue, or throat
• problems breathing or swallowing
• severe rash or itching
• fainting or feeling dizzy
• very rapid heartbeat

Do not take albiglutide if you:

• are allergic to albiglutide or to any of its ingredients
• or your family has a history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of albiglutide, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking albiglutide, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to albiglutide or to any of its ingredients
• severe stomach or intestinal problems
• previously had pancreatitis
• you or your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC)
• you have an endocrine system cancer called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• have or have had problems with your pancreas, kidneys, or liver 
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or
  problems with digesting food
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Albiglutide falls into category C.There are no well-controlled studies that have been done in pregnant women. Albiglutide should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if albiglutide crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using albiglutide.

Take albiglutide exactly as prescribed.

This medication comes in an injectable form. Albiglutide is given under the skin, once every seven days (weekly), on the same day each week.

Albiglutide may be administered at any time of day and may be taken with or without food.

Albiglutide is injected under the skin (subcutaneously) in the abdomen, thigh, or upper arm region.

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

If you miss a dose, take your missed dose of medicine within 3 days after your scheduled day, then return to your scheduled day for your next dose. If more than 3 days have passed since your usual scheduled day, wait until your next regularly scheduled day to take the injection of albiglutide. Do not take two doses of albiglutide at the same time.

Albiglutide pen

Your healthcare provider must teach you how to inject albiglutide before you use it for the first time. If you have questions or do not understand the instructions, talk to your healthcare provider or pharmacist.

• If stored in a refrigerator, allow to sit at room temperature for 15 minutes before starting.
• The albiglutide pen has medicine powder in 1 compartment and water in another compartment. You will need to mix them together by twisting the pen, then wait for 15 minutes for the medicine and water to fully mix.
• Do not mix insulin and albiglutide together in the same injection.
• Albiglutide is injected under the skin (subcutaneously) in the abdomen, thigh, or upper arm region. Do not inject albiglutide into a vein or muscle.
• Change (rotate) your injection site with each injection (weekly).

General Information

Follow your healthcare provider's instructions for diet, exercise, and how often to test your blood sugar. If you see your blood sugar increasing during treatment with albiglutide, talk to your healthcare provider because you may need to adjust your current treatment plan for your diabetes.

Talk to your healthcare provider about how to manage high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia), and how to recognize problems that can happen with your diabetes.

Never share your albiglutide with another person. You may give an infection to them, or get an infection from them, and albiglutide may harm them.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on how you respond to this medication.

The recommended dose of albiglutide used to control blood glucose (sugar) in people with type 2 diabetes is 30 mg once every seven days (weekly). The dose can be administered at any time of day, with or without meals.

If you take too much albiglutide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Too much albiglutide can cause your blood sugar to drop quickly and you may have symptoms of low blood sugar. You may need medical treatment right away.

• Store albiglutide pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Patients may store albiglutide pens at room temperature not to exceed 86°F (30°C) for up to 4 weeks prior to use.
• Store albiglutide pens in the original carton until use.
• Do not freeze. If the liquid in the pen is frozen, throw away the pen and use another pen.
• Do not use past the expiration date.
• Use within 8 hours after reconstitution.
• Keep this and all medicines out of the reach of children.

WARNING: RISK OF THYROID C-CELL TUMORS

Tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists. It is unknown whether albiglutide causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Albiglutide should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).