Generic Name and Formulations:
Albiglutide [recombinant fusion protein] 30mg, 50mg; per pen; lyophilized pwd for SC inj after reconstitution; preservative-free.
Indications for TANZEUM:
Adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Limitations Of use:
Not recommended as first-line treatment for patients inadequately controlled on diet and exercise. Not studied in combination with prandial insulin or with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
Give by SC inj in the abdomen, thigh, or upper arm on the same day each week without regard to meals. Rotate inj sites (esp. when concomitant insulin). Initiate at 30mg once weekly; may increase to 50mg once weekly if inadequate response. Renal impairment and/or in those with severe GI symptoms: caution with initiating or escalating doses.
<18yrs: not established.
History (personal or family) of medullary thyroid carcinoma (MTC). Multiple endocrine neoplasia syndrome type 2 (MEN 2).
Risk of thyroid C-cell tumors, including MTC; inform patients of risks and symptoms. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of pancreatitis; consider other antidiabetic therapies. Renal impairment and/or in those with severe GI symptoms: risk of dehydration; avoid fluid depletion. Pregnancy (Cat.C). Nursing mothers: not recommended.
Increased risk of hypoglycemia with concomitant sulfonylureas or insulin; consider reducing their doses. May affect absorption of other oral drugs (delayed gastric emptying).
Glucagon-like peptide-1 (GLP-1) receptor agonist.
Upper respiratory tract infection, diarrhea, nausea, inj site reaction; acute pancreatitis, hypersensitivity reactions (discontinue if occurs), acute kidney injury.
Single-dose pen—4 (w. needles)