Albiglutide

DEA Class; Rx

Common Brand Names; Tanzeum

Hypersensitivity

Personal or family history of medullary thyroid carcinoma

Multiple endocrine neoplasia type 2 (MEN-2)

Carcinogenicity of albiglutide could not be assessed in rodents due to rapid development of drug-clearing, anti-drug antibodies; other GLP-1 receptor agonists have caused dose-related and treatment-duration-dependent thyroid C-cell tumors (adenomas or carcinomas) in rodents; human relevance of GLP-1 receptor agonist induced C-cell tumors in rodents not determined; cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, reported in postmarketing period; data in these reports are insufficient to establish or exclude causal relationship between MTC and GLP-1 receptor agonist use in humans (see Black Box Warnings and Contraindications); routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with albiglutide; significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; if serum calcitonin is measured and found to be elevated, evaluate patient further; patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated

Acute pancreatitis reported (rare); discontinue if pancreatitis suspected and do not restart if confirmed; consider other antidiabetic therapies in patients with a history of pancreatitis

Hypoglycemia may occur when used in combination with insulin secretagogues (eg, sulfonylureas) or insulin; consider lowering sulfonylurea or insulin dosage when starting albiglutide

Serious hypersensitivity reactions reported, including angioedema and generalized pruritus, rash, and dyspnea; discontinue albiglutide if such reactions occur

Anaphylaxis and angioedema reported with other GLP-1 receptor agonists; use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with therapy

Acute renal failure and worsening of chronic renal failure (some requiring hemodialysis) reported with treatment with GLP-1 receptor agonists; monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions; use caution when initiating or escalating doses in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms; advise patients of potential risk of dehydration in relation to gastrointestinal side effects and to take precautions to avoid fluid depletion

Clinical trials have not established conclusive evidence of macrovascular risk reduction with albiglutide or any other antidiabetic drug

Pregnancy Category: C

Because of the long washout period for albiglutide, consider discontinuing at least 1 month before a planned pregnancy

Lactation: Unknown if distributed in human breast milk; a decision should be made whether to discontinue breastfeeding or to discontinue albiglutide, taking into account the importance of the drug to the mother and the potential risks to the infant

Since albiglutide is an albumin-based protein, it should be assumed that it is present in human milk; decreased body weight in offspring was observed in mice treated with albiglutide during gestation and lactation