Albiglutide (Tanzeum)

Use is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

A once weekly G LP-1 receptor agonist

Dosage form is injection: powder, lyophilized, for solution

Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures.

It is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

Use is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in treated patients.

Not recommended as first-line therapy for diabetic patients inadequately controlled on diet and exercise.

In the Albiglutide and Cardiovascular Outcomes in Patients with type twoDiabetes and Cardiovascular disease trial results suggested beneficial cardiovascular effects of GLP-1RAs.

Has not been studied in patients with a history of pancreatitis, gastroparesis, and is not recommended for patients with pre-existing severe gastrointestinal disease.

Not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.

The recommended dosage is 30 mg once weekly on the same day, given as a subcutaneous injection in the abdomen, thigh, or upper arm region.

Dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.

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

If a dose is missed, patients should administer another dose as soon as possible within 3 days after the missed dose.

If it is more than 3 days after a missed dose, patients are to wait until their next regularly scheduled weekly dose.

When initiating therapy, consider reducing the dosage of concomitantly administered insulin secretagogues or insulin to reduce the risk of hypoglycemia.

No dose adjustment is needed in patients with mild, moderate, or severe renal impairment.

The lyophilized powder contained within the Pen must be reconstituted prior to administration.

Subcutaneously administered, and must not be administered intravenously or intramuscularly.

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