TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk. Has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis. Not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis; is not a substitute for insulin in these patients. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis; is not recommended in patients with pre-existing severe gastrointestinal disease. Has not been studied in combination with prandial insulin.
Carcinogenicity of albiglutide could not be assessed in rodents, but other glucagon-like peptide-1 (GLP-1) receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures. Human relevance of GLP-1 receptor agonist induced C-cell tumors in rodents has not been determined. It is unknown whether TANZEUM® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use of TANZEUM and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with TANZEUM.
Hypersensitivity: TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.
WARNINGS AND PRECAUTIONS
Risk of Thyroid C-cell Tumors: Counsel patients regarding the potential risk for MTC with the use of TANZEUM and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TANZEUM. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Acute Pancreatitis: 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. TANZEUM has not been studied in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: 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.
Hypersensitivity Reactions: Across 8 Phase III clinical trials, a serious hypersensitivity reaction with pruritus, rash, and dyspnea occurred in a patient treated with TANZEUM. If hypersensitivity reactions occur, discontinue use of TANZEUM; treat promptly per standard of care and monitor until signs and symptoms resolve.
Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In a trial of TANZEUM in patients with renal impairment, the frequency of such gastrointestinal reactions increased as renal function declined. Because these reactions may worsen renal function, 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.
Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with TANZEUM or any other antidiabetic drug.
The most common adverse reactions, excluding hypoglycemia, reported in ≥5% of patients treated with TANZEUM and more commonly than in patients treated with placebo, are: upper respiratory tract infection (14.2 vs 13.0); diarrhea (13.1 vs 10.5); nausea (11.1 vs 9.6); injection site reaction (10.5 vs 2.1); cough (6.9 vs 6.2); back pain (6.7 vs 5.8); arthralgia (6.6 vs 6.4); sinusitis (6.2 vs 5.8); influenza (5.2 vs 3.2).
TANZEUM delays gastric emptying and may impact absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TANZEUM.
USE IN SPECIFIC PATIENT POPULATIONS
Pediatric Use: Safety and effectiveness of TANZEUM have not been established in pediatric patients (younger than 18 years).
TANZEUM is a registered trademark of the GSK group of companies.
824140R0 July 2017