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U.S. Department of Health and Human Services

Safety

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Victoza (liraglutide [rDNA]) injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Renal Impairment

  • Victoza has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza-treated patients [see Adverse Reactions (6.2)]
 
Hypersensitivity Reactions
  • There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza. If a hypersensitivity reaction occurs, the patient should discontinue Victoza and other suspect medications and promptly seek medical advice.
  • Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza.
 

ADVERSE EVENTS

Post-Marketing Experience
  • Angioedema and anaphylactic reactions
 
MEDICATION GUIDE
How Should I use Victoza
  • If you also give yourself insulin injections in addition to Victoza, never mix insulin and Victoza together. Give yourself 2 separate injections. You may give both injections in the same body area (for example, your stomach area), but you should not give the injections right next to each other.