Expanded Indication for Victoza
August 25, 2017 – The U.S. FDA has approved an expanded indication for Victoza® (liraglutide), manufactured by Novo Nordisk, as a treatment to decrease the risk of major adverse cardiovascular events in adults who have both type 2 diabetes and documented cardiovascular disease. The drug was originally approved in 2010 to be used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
A glucagon-like peptide-1 (GLP-1) receptor agonist, Victoza is delivered subcutaneously through a pre-filled, multi-dose pen. Recommended dosing is once per day, at any time, and is independent of meals. Patients should begin with 0.6mg per day for one week, then increase to 1.2mg per day for standard maintenance. The dosage can be increased up to a maximum of 1.8mg per day if needed.
Victoza carries a black box warning that it has been associated with the development of thyroid C-cell tumors, and that its use is contraindicated in patients who have medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2), as well as patients with a family history of MTC and MEN 2.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.