Albiglutide

Albiglutide (Tanzeum) is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1) which is used in combination with diet and exercise in the therapy of type 2 diabetes, either alone or in combination with other antidiabetic agents.

What are the uses of this medicine?

• This medicine is used to improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise.

Limitations of use:

• Tanzeum is not recommended as the first choice of medicine for treating diabetes.
• It is not known if Tanzeum can be used in people who have had pancreatitis.
• Tanzeum is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
• Tanzeum is not recommended for use in people with severe stomach or intestinal problems.
• It is not known if Tanzeum can be used with mealtime insulin.
• It is not known if Tanzeum is safe and effective for use in children under 18 years of age.

How does this medicine work?

• Albiglutide (al" bi gloo' tide) is a glucagon-like peptide-1 (GLP-1) analogue (also called a GLP-1 receptor agonist) that acts like the native gastrointestinal hormone (incretin) to increase insulin secretion.
• Albiglutide reproduces the activity of GLP-1, binding to specific receptors on pancreatic beta cells and increasing insulin secretion, which can lead to improvement of glycemic control in patients with type 2 diabetes.
• Albiglutide is a recombinant DNA-produced polypeptide consisting of two 30-amino acid sequence molecules that are fused as a tandem repeat.
• The amino acid sequence of albiglutide is >90% homologous to endogenous human GLP-1(7-37) and differs only by a single amino acid substitution, which makes it resistant to degradation by dipeptidyl peptidase 4 (DPP4).
• The half-life of albiglutide is further prolonged by coupling of two recombinant molecules to human serum albumin.
• Albiglutide, like other GLP-1 analogues, must be given parenterally, but it has a half-life of 5 days which allows for once weekly dosing.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• are allergic to albiglutide or any of the ingredients in Tanzeum.

What drug interactions can this medicine cause?

• Tanzeum delays gastric emptying. May impact absorption of concomitantly administered oral medications.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage of Tanzeum is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.
• Use caution when initiating or escalating doses of Tanzeum in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions
• When initiating Tanzeum, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Administration

1. Read the Instructions for Use including the Frequently Asked Questions that comes with Tanzeum the first time you give yourself an injection and again each time you give yourself an injection.
2. Use Tanzeum exactly as your healthcare provider tells you to.
3. Your healthcare provider should show you how to use Tanzeum before you use it for the first time.
4. Tanzeum is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Tanzeum into a muscle (intramuscularly) or vein (intravenously).
5. Use Tanzeum 1 time each week on the same day each week at any time of the day.
6. You may change the day of the week as long as your last dose was given 4 or more days before.
7. If you miss a dose of Tanzeum, take the missed dose of Tanzeum within 3 days after your usual scheduled day. If more than 3 days have gone by since your missed dose, wait until your next regularly scheduled weekly dose. Do not take 2 doses of Tanzeum within 3 days of each other.
8. Tanzeum may be taken with or without food.
9. Tanzeum should be injected within 8 hours after mixing your medicine.
10. Tanzeum should be injected right after you attach the needle.
11. When using Tanzeum with insulin, you may inject these medications in the same area of your body, but do not inject them right next to each other.
12. Do not mix insulin and Tanzeum together in the same syringe.
13. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
14. If you take too much Tanzeum, call your doctor or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 30 mg or 50 mg in a single-dose Pen

This medicine is available in fallowing brand namesː

• Tanzeum

What side effects can this medication cause?

The most common side effects of this medicine include:

• upper respiratory tract infection
• back pain
• diarrhea
• joint pain
• nausea
• inflammation of the sinuses
• reactions at your injection site
• flu symptoms
• cough

Tanzeum may cause serious side effects, including:

• Possible thyroid tumors, including cancer
• inflammation of your pancreas (pancreatitis)
• low blood sugar (hypoglycemia)
• serious allergic reactions
• kidney injury

What special precautions should I follow?

• Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2.
• In clinical trials, acute pancreatitis has been reported in association with Tanzeum. After initiation of Tanzeum, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, promptly discontinue Tanzeum. If pancreatitis is confirmed, Tanzeum should not be restarted.
• The risk of hypoglycemia is increased when Tanzeum is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Therefore, patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting
• Serious hypersensitivity reactions (including angioedema and generalized pruritus and rash with dyspnea) have been reported with Tanzeum. . If hypersensitivity reactions occur, discontinue use of Tanzeum; treat promptly per standard of care, and monitor until signs and symptoms
• resolve.
• Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
• There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known if Tanzeum will harm your unborn baby. Tell your healthcare provider if you become pregnant while using Tanzeum.

Can this medicine be used in children?

• It is not known if Tanzeum is safe and effective for use in children under 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: albiglutide
• Inactive Ingredients: mannitol, polysorbate 80, sodium phosphate, and trehalose dihydrate. Tanzeum does not contain a preservative.

Who manufactures and distributes this medicine?

• Manufactured by:
• GlaxoSmithKline LLC
• Wilmington,
• Marketed by GlaxoSmithKline Research Triangle Park

What should I know about storage and disposal of this medication?

Prior to dispensing:

• Store Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Pens may be stored refrigerated until the expiration date.

Following dispensing:

• Store Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Patients may store Pens at room temperature not to exceed 86°F (30°C) for up to 4 weeks prior to use.
• Store Pens in the original carton until use.
• Do not freeze.
• Do not use past the expiration date.
• Use within 8 hours after reconstitution.

• Dailymed label info on Albiglutide
• FDA Albiglutide

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