See Supplemental Patient Information
- Dose-dependent and treatment-duration-dependent thyroid C-cell tumors have occurred at clinically relevant exposures in both genders of rats and mice
- Albiglutide is contraindicated in patients with a personal history or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [US Black Box Warning]
- It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease [US Black Box Warning]
- In clinical trials, there were more cases of pancreatitis among albiglutide treated patients. Observe patients carefully for signs and symptoms of pancreatitis after initiation of therapy and after dose increases, if pancreatitis is suspected, discontinue therapy. Do not restart if pancreatitis is confirmed
- Serious hypoglycemia can occur if albiglutide is used with an insulin secretagogue (e.g., sulfonylurea). Reduce dose of insulin secretagogue
- Concomitant use of oral sulfonylureas increase risk of hypoglycemia
- Serious hypersensitivity reactions such as anaphylactic reactions and angioedema have been reported in patients treated with albiglutide, if such reactions develop discontinue the treatment and promptly seek medical advice
- Acute renal failure and worsening of chronic renal failure have been reported. Monitor renal function in patients reporting severe adverse gastrointestinal reactions
- There have been no any clinical report of macrovascular risk reduction with albiglutide or any other antidiabetic drug
- Use has not been studied in combination with parandial insulin
Cautions: Use cautiously in
- History of pancreatitis
- Gastroparesis
- Concurrent insulin
Supplemental Patient Information
- Patient should be informed that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting
- Patients should be informed to report symptoms of thyroid tumors (e.g., a lump in the neck, hoarseness, dysphagia or dyspnea) to their physician
Pregnancy Category:C
Breastfeeding: Safety unknown. As many drugs are excreted in human milk, Manufacturer recommends discontinuation of nursing or drug, taking into account the importance of the drug to the mother.
4 days before
