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Originator: DHSC & NHS England and Improvement: Supply disruption alert

Issue date: 21-Dec-2021 08:43:12

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • MHRA (Medicines) Drug Alerts (Various Recipients)
  • Other contacts
  • Specialists Trusts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • MHRA (Medicines) Drug Alerts - Non-NHS Recipients
  • Mental Health & Learning Disabilities Trusts
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • Acute Trusts
  • Community Trusts
  • DHSC Supply Disruption - Medicines

Action category: Action

Title: Advanz epoprostenol 0.5mg and 1.5mg powder and solvent (pH10.5) solution for infusion vials - Supply Disruption

Broadcast content:
  • Advanz epoprostenol 0.5mg powder and solvent (pH10.5) for solution for infusion is out of stock with resupply anticipated by end of February 2022 at the earliest, (exact date to be confirmed). 
  • Advanz epoprostenol 1.5mg powder and solvent (pH10.5) for solution for infusion remains in stock, but as supply is very limited until the anticipated resupply date of end of February 2022; this stock has been ringfenced for use in paediatric homecare patients with pulmonary hypertension only.
  • Alternative epoprostenol products remain available:
    • Epoprostenol 0.5mg and 1.5mg powder and solvent (pH12) for solution for infusion (FlolanĀ®) can support an uplift in demand, however Trusts need to consider the implications of using a higher pH presentation (see advice on switching patients to alternative treatments detailed in the alert)
    • Epoprostenol 0.5mg and 1.5mg powder (pH12) for solution for infusion vials (VeletriĀ®) is unable to meet any increase in demand.
This alert contains further information and action for providers.

Please note that no response is required via the CAS website to this alert.

Additional information: This alert is not relevant to Primary Care.

Alert reference: SDA/2021/016


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Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency