Integrilin Supply Problem: GSK Halts Production – Alternatives and Recommendations by ANSM

2023-11-27 11:58:36

The GlaxoSmithKline laboratory (GSK) is stopping the manufacture of Integrilin earlier than expected due to a supply problem with its active substance.

Notice to patients treated for a heart attack, stroke or cerebral aneurysm. L’National Medicines Agency (ANSM) informs on November 24, 2023 of the withdrawal from the European market, therefore French, of Integrilin. Its manufacturer, the GlaxoSmithKline laboratory (GSK), stopped producing it because of a supply problem. eptifibatidethe active ingredient in Integrilin. “GSK will not be able to manufacture further batches of Integrilin for at least 18 months and has therefore made the decision to stop manufacturing all formulations of Integrilin with immediate effectthus anticipating the discontinuation of the product planned for the end of 2024details the ANSM in a letter sent to health professionals at the end of October. This medicine was available in hospitals in two forms:

Integrilin 2 mg/ml, solution injectable
Integrilin 0,75 mg/ml, solution pour perfusion

Integrilin belongs to the therapeutic class of agents antithrombotic (anti-clot), inhibitors of platelet aggregation. It is used to prevent early myocardial infarction. in adults with unstable angina or myocardial infarction without Q wave with a final episode of chest pain occurred within 24 hours, accompanied by changes in the electrocardiogram (ECG) and/or elevation of cardiac enzymes. It is also used in neurology in the treatment of stroke ischemic or intracranial aneurysms. The withdrawal concerns the EU, Armenia, Russia, Switzerland, Ukraine and the United Kingdom. “This manufacturing stoppage is not due to safety concerns or the effectiveness of Integrilin” specifies the ANSM.

What alternatives?

The Medicines Agency recommends that healthcare professionals use the Tirofiban® (Agrastat and generics) or Cangrelor® (Kengrexal) as therapeutic alternatives, depending on the indication and clinical context. From now on, healthcare professionals must notstart new patients on Integrilin if there are not enough vials to complete their treatment and consider prescribing an alternative medication.

1701092641
#Due #lack #stock #treatment #heart #attacks #strokes #aneurysms #withdrawn #market

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.