FDA Modifies REMS for Tanzeum, Trulicity
The Food and Drug Administration (FDA) announced modifications to the Tanzeum (albiglutide [recombinant fusion protein]; GlaxoSmithKline) and Trulicity (dulaglutide; Eli Lilly) Approved Risk Evaluation and Mitigation Strategies (REMS) program following the safety labeling changes that were approved in March 2015.
Safety labeling changes from March 2015 include:
- Boxed warning: Risk of thyroid C-cell tumors including medullary thyroid carcinoma (MTC). It is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2).
- Limitations of use: Not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe only to patients for whom the potential benefits outweigh the potential risk.
The modifications will be reflected in the REMS document and the following REMS appended materials: REMS Letter for Healthcare Providers, REMS Letter for Professional Societies, REMS Factsheet, and the REMS Webpage.
Both Tanzeum and Trulicity are glucagon-like peptide (GLP-1) receptor agonists indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
For more information call (888) 463-6332 or visit FDA.gov.