Label Changes for:

Agrylin (anagrelide hydrochloride) Capsules

July 2013

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

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

 

July 2013

WARNINGS

Cardiovascular

Torsades de pointes and ventricular tachycardia have been reported with anagrelide treatment. Obtain a pre-treatment cardiovascular examination, including an ECG in all patients. During treatment with Agrylin, monitor patients for cardiovascular effects and evaluate as necessary.

Anagrelide is a phosphodiesterase 3 (PDE3) inhibitor and may cause vasodilation, tachycardia, palpitations, and congestive heart failure. Other drugs that inhibit PDE3 have caused decreased survival when compared with placebo in patients with Class III-IV congestive heart failure. In patients with cardiac disease, use Agrylin only when the benefits outweigh the risks.

ADVERSE REACTIONS

Postmarketing Reports
  • Cases of torsades de pointes, ventricular tachycardia

 

November 2011 

PRECAUTIONS

  • Bleeding: Use of concomitant anagrelide and aspirin increased major hemorrhagic events in a postmarketing study. Assess the potential risks and benefits for concomitant use of anagrelide with aspirin, particularly in patients with a high risk profile for hemorrhage.
  • Drug Interactions: Analyses of an ongoing observational study in patients with ET suggest the rate of major hemorrhagic events (MHEs) in patients treated with anagrelide is higher than in those subjects treated with another cytoreductive treatment. The majority of the major hemorrhagic events occurred in patients who were also receiving concomitant anti-aggregatory treatment (primarily, aspirin). Therefore, the potential risks of the concomitant use of anagrelide with aspirin should be assessed, particularly in patients with a high risk profile for hemorrhage, before treatment is initiated 

 

January 2011 

ADVERSE REACTIONS

Postmarketing Reports
  • tubulointerstitial nephritis added

 

July 2009 

PRECAUTIONS

Drug Interactions

  • In two clinical interaction studies in healthy subjects, co-administration of single-dose anagrelide 1mg and aspirin 900mg or repeat-dose anagrelide 1mg once daily and aspirin 75mg once daily showed greater ex vivo anti-platelet aggregation effects than administration of aspirin alone... 
  • Drug interaction studies have not been conducted with the other common medications used concomitantly with anagrelide in clinical trials which were acetaminophen, furosemide, iron, ranitidine, hydroxyurea, and allopurinol.

 

 

November 2011

Hide
(web5)