Tanzeum by GlaxoSmithKline

The FDA has approved GlaxoSmithKline’s Tanzeum (albiglutide) subcutaneous injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The approval, however, carries with it several limitations: (1) the medication is not recommended as first-line therapy for patients inadequately controlled on diet and exercise; (2) it has not been studied in patients with a history of pancreatitis; (3) it is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis; (4) it is not for patients with preexisting severe gastrointestinal disease; and (5) it has not been studied in combination with prandial insulin.¹ Approximately 24 million Americans and 382 million people worldwide are affected by diabetes, with up to 95% of these cases being T2DM.^2,3

Pharmacology and Pharmacokinetics

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is an incretin hormone that helps to reduce blood glucose levels; it is often reduced or absent in patients with T2DM.² Tanzeum augments glucose-dependent insulin secretion and slows gastric emptying. 1 It has an elimination half-life of approximately 5 days. Age, gender, race, and body weight do not affect the pharmacokinetics of Tanzeum.¹

Dosage and Administration

Tanzeum should be given subcutaneously in the abdomen, thigh, or upper arm as a 30-mg dose once weekly, and may be increased to 50 mg once weekly in patients needing additional glycemic control. The dose can be given at any time of day, without regard to meals. If a dose is missed, administer a dose within 3 days. Tanzeum is available as a 30-mg or 50-mg single-dose pen.¹

Clinical Trials

The safety and efficacy of Tanzeum was evaluated in 8 clinical trials of more than 2000 patients with T2DM. It has been studied alone and in combination with metformin, metformin and a sulfonylurea, a thiazolidinedione (with and without metformin), and insulin glargine (with or without oral antidiabetic drugs).^1,3 The efficacy of Tanzeum was compared with placebo, glimepiride, pioglitazone, liraglutide, sitagliptin, insulin lispro, and insulin glargine. In patients with T2DM, treatment with Tanzeum resulted in a clinically relevant reduction from baseline in glycated hemoglobin compared with placebo.¹

Contraindications, Warnings, and Precautions

Tanzeum carries a boxed warning that thyroid C-cell tumors have been observed in rodents using GLP-1 receptor agonists at clinically relevant exposures. It is unknown if Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Its use is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2. Tanzeum is also contraindicated in patients with a history of serious hypersensitivity to the medication or any of its components.

Treatment with Tanzeum should be discontinued immediately if pancreatitis or hypersensitivity is suspected. Hypoglycemia may occur during concomitant use with insulin or an insulin secretagogue. Patients with renal impairment who report severe adverse gastrointestinal reactions should have their renal function monitored. No clinical studies have established conclusive evidence that treatment with Tanzeum, or any other antidiabetic medication, will reduce the macrovascular risks of diabetes.

Tanzeum delays gastric emptying and may impact the absorption of concomitantly administered oral medications. Tanzeum is also Pregnancy Category C and should only be used during pregnancy if the potential benefit outweighs the potential fetal risk. Patients who are breast-feeding should not use the drug. The most commonly reported adverse reactions (≥10%) are upper respiratory tract infection, diarrhea, nausea, and injection site reaction.¹

Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.

References

• Tanzeum complete prescribing information. Available at https://www.gsksource.com/gskprm/htdocs/documents/TANZEUM-PI-MG-IFU-COMBINED.PDF Accessed February 2015.
• GSK receives US approval for once-weekly type 2 diabetes treatment, Tanzeum (albiglutide) Available at http://www.gsk.com/en-gb/media/press-releases/2014/gsk-receives-us-approval-for-once-weekly-type-2-diabetes-treatment-tanzeum-albiglutide/ Accessed February 2015.
• FDA approves Tanzeum to treat type 2 diabetes. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393289.htm Accessed February 2015.