Albiglutide

Name: Albiglutide

Uses of Albiglutide

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 Food Interactions

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.

Albiglutide Usage

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 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.

Albiglutide Dosage

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.

Albiglutide FDA Warning

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).

Albiglutide Brand Names

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

  • Tanzeum

Side Effects of Albiglutide

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.

Albiglutide Usage

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.

What is albiglutide?

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

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

This medicine is not for treating type 1 diabetes.

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

What should I avoid while using albiglutide?

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

Uses for Albiglutide

Diabetes Mellitus

Used as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.1 10

Used alone or as add-on therapy with metformin, the combination of metformin and a sulfonylurea, a thiazolidinedione with or without metformin, and insulin glargine with or without oral antidiabetic agents.1 10

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise alone because of potential thyroid C-cell tumor risk and risk of acute pancreatitis.1 13

Safety and efficacy not established in patients with a history of pancreatitis; consider other antidiabetic agents.1

Not recommended for use in patients with severe GI disease, including severe gastroparesis.1

Safety and efficacy in combination with prandial insulin not established.1

Not indicated for use in patients with type 1 diabetes mellitus or diabetic ketoacidosis.1

Uses of Albiglutide

  • It is used to lower blood sugar in patients with high blood sugar (diabetes).

Brand Names U.S.

  • Tanzeum

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Because of the long washout period, consider stopping albiglutide at least 1 month before a planned pregnancy.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2017c; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and Hb1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2017c; Blumer 2013; Kitzmiller 2008). Agents other than albiglutide are currently recommended to treat diabetes in pregnant women (ACOG 2013; ADA 2017c; Blumer 2013).

Dosing & Uses

Dosage Forms & Strengths

lyophilized powder for reconstitution

  • 30mg/pen
  • 50mg/pen
  • Available as a single-use injectable pen

Diabetes Mellitus, Type 2

Glucagonlike peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

30 mg SC once weekly; may increase to 50 mg once weekly if glycemic response is inadequate

Limitations of Use

Not recommended as first-line therapy for patients inadequately controlled on diet and exercise; prescribe albiglutide only to patients for whom potential benefits are considered to outweigh potential risks

Has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis

Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis

Not for patients with pre-existing severe gastrointestinal disease

Has not been studied in combination with prandial insulin

Dosage Modifications

Renal impairment (any severity): No dosage adjustment required

Safety and efficacy not established

Renal Dose Adjustments

Mild, moderate, or severe renal impairment (eGFR 15 to 89 mL/min/1.73m2): No adjustment recommended; use caution when initiating or escalating doses
-eGFR less than 15 mL/min/1.73m2: No data available

Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions

Liver Dose Adjustments

No dose adjustment recommended

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