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Important information for patients prescribed intravenous epoprostenol (Flolan brand)

Posted on March 27th 2024

UPDATED TUESDAY 16th APRIL 2024

At the end of March, we made our PH community aware of a supply issue affecting Flolan, which is also called epoprostenol.  This is prescribed intravenously for around 200 adults and children with pulmonary hypertension in the UK.

Please note, this issue affects BOTH 1.5mg Flolan and 0.5mg Flolan strengths.

The manufacturers, GlaxoSmithKline (GSK), have made us aware of a ‘pause in supply’ which has resulted in less of the drug being imported to the UK than normal.

The drug is only manufactured in Italy, and we have been told this is a global issue affecting all patients around the world.

The situation as of Tuesday 16th April:

We have been advised by GSK that there is enough stock to last until more deliveries arrive in May. These shipments are due to arrive on 7th, 22nd, and 29th May. The dates for June deliveries are not yet confirmed, but we have been advised that ‘manufacturing is recovering’.

The situation is looking more positive than it did a few weeks ago, and the Pulmonary Hypertension Association (PHA UK) along with PH teams from every affected centre are aware and working hard with NHS England and GSK to lessen the impact for patients. We will continue to provide updates on a regular basis, at least every week.

At the moment, GSK have not provided any details as to what caused the temporary halt to production.  However, we have been assured that it has not caused any potential risk to the quality and safety of Flolan in use at present or in the future.

Therefore, we are reassured it is safe for you to continue taking this drug.

Although production has now re-started, it is still anticipated that there will be a level of supply disruption for the next few weeks, because of the backlog of orders.

What do I need to do if I take epoprostenol (Flolan)?

Please carefully check your current stock levels of Flolan at home. You will receive phone calls from your homecare delivery company, asking how much you hold, so please take or return these calls as a priority.

It is important that you are accurate and honest about your stock levels when called.

We understand that this situation may cause you concern, but it’s very important that you continue to take the prescribed dosage of Flolan; please do not try to ‘stretch it out’ to make your supply last longer.

Patients prescribed this drug should not stockpile supplies because of this situation.

This situation has highlighted the importance of patients always holding an additional ‘buffer’ supply of two weeks of this drug at home.

What is being done to try and solve the supply problem?

PH teams at the affected centres and the PHA UK are working hard with GSK (the manufacturer) and homecare delivery companies to try to get these supply issues resolved as quickly and safely as possible.

The PHA UK asked GSK for a formal statement and an apology to patients affected by this issue. This is what they provided: “We take our responsibility to ensure reliable and consistent supply of medicines extremely seriously and regret we are currently experiencing temporary issues relating to the supply of Flolan. We are working hard to resolve the situation as quickly as possible and commit to keeping the PHA regularly updated.”

Who should I contact if I have any questions or concerns about this?

If you have not already been called about your current stock levels, please contact your homecare delivery company urgently.

Please do not contact your specialist centre as all the information available will be updated here. The team there will not know any more details.

We will continue to review the situation and to provide updates via this web page and on our social media channels.

A message from Dr Iain Armstrong, Chair of the PHA UK: