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Health Department St Andrew’s House
Regent Road
Edinburgh EH1 3DG
URGENT MESSAGE TO:
Telephone: 0131-244 2799
1. All Directors of Public Health Fax: 0131-244 2835
2. Medical Directors of NHS Acute Trusts for cascade to aileen.keel@scotland.gsi.gov.uk
Consultant Renal Physicians, Renal Surgeons, Haematologists,
NHS Trust Chief Pharmacists for further distribution to hospital
pharmacists.
3. Directors of Nursing NHS Trusts for cascade to renal
/dialysis unit and haematology nursing staff
4. NHS 24 Date: 12 December 2002
5. SCIEH
_____ _____
Dear Colleague
EPREX® (EPOETIN ALFA) AND PURE RED CELL APLASIA – CONTRAINDICATION
OF SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH CHRONIC RENAL
DISEASE
Please find attached for urgent transmission (see list below) a copy of a message from Professor
Alasdair Breckenridge, Chairman of the Committee on Safety of Medicines about important changes
to the prescribing information for Eprex. This resulted from investigations into pure red cell aplasia
(PRCA, erythroblastopenia) in patients treated with Eprex.
1. Medical directors of NHS Acute Trusts please forward to:
● Consultant Renal Physicians, renal surgeons, haematologists
● Trust Chief Pharmacists for further distribution to hospital pharmacists
● Directors of Nursing NHS Trusts for further distribution to renal/dialysis unit and
haematology nursing staff
2. Directors of Public Health please forward to:
● Chief Executives, NHS Boards
Thank you for your help in this matter.
Yours sincerely
DR AILEEN KEEL
Deputy Chief Medical Officer
EPREX® (EPOETIN ALFA) AND PURE RED CELL APLASIA?
CONTRAINDICATION OF SUBCUTANEOUS ADMINISTRATION TO PATIENTS
WITH CHRONIC RENAL DISEASE
Dear Health Professional
Important changes to the prescribing information for Eprex as a result of
investigations into pure red cell aplasia (PRCA, erythroblastopenia) in
patients
treated with Eprex.
The subcutaneous route should not be used to administer Eprex to patients
with
chronic renal failure.
Monitoring of reticulocyte count at regular intervals is recommended to
detect
possible occurrence of lack of efficacy.
Recommended storage conditions (between 2°C and 8°C) should be adhered to
at
all times.
Eprex and PRCA ? current status
By the end of September 2002 there were 155 case reports of PRCA confirmed
by
bone marrow biopsy world-wide; of these, 112 reports had documented the
presence
of anti-erythropoietin antibodies. Where the route of administration could
be
determined, all patients with anti-erythropoietin antibodies had received
subcutaneous
Eprex. All but one of these cases were reported in patients with chronic
renal failure
(CRF). For patients with antibody-mediated PRCA in whom duration of
treatment was
reported, lack of efficacy was first noted between 4 and 24 months after
the start of
treatment with Eprex. In the UK there have been 24 reports of PRCA, 20 of
which also
reported anti-erythropoietin antibodies.
These data support the contraindication of the administration of Eprex by
the
subcutaneous route to any patient with CRF. The product information for
Eprex has
been amended accordingly, to strengthen previous warnings about PRCA of
November 2001 and July 2002.
Advice to prescribers:
Patients who are currently receiving Eprex subcutaneously for anaemia
associated
with chronic renal disease should have their treatment changed at the next
convenient opportunity. Subcutaneous administration of Eprex should then
cease.
Eprex may still be administered intravenously to these patients.
If intravenous administration of Eprex is not feasible, appropriate
alternative
treatment should be given.
In other approved indications there is no evidence to date of an increased
risk of
PRCA, and Eprex may continue to be administered subcutaneously.
Monitoring during treatment with Eprex
Pure red cell aplasia will usually present as an anaemia that fails to
respond to
treatment with erythropoietins. Monitoring of reticulocyte count at regular
intervals is
recommended to detect possible occurrence of lack of efficacy. Any
unexplained
reticulocytopenia should be investigated as described in the product
information (i.e.
exclusion of typical causes of non-response to epoetins, followed if
necessary by bone
marrow biopsy and measurement of anti-erythropoietin antibodies).
If PRCA is diagnosed, therapy with Eprex must be discontinued immediately
and
testing for erythropoietin antibodies should be considered. Patients
should not be
switched to another product as anti-erythropoietin antibodies cross-react
with other
erythropoietins.
Please report any cases of PRCA associated with Eprex or other epoetins
through the
Yellow Card Scheme.
Conditions of storage
Investigations into potential causes of the apparent association between
Eprex and
PRCA revealed that the recommended conditions of storage have not been
consistently followed. While the role played by conditions of storage in
PRCA is not
clear, it is important that the product should be stored at temperatures
between 2°C
and 8°C.
Further information
For telephone enquiries - please call the Medicines Control Agency 020 7273
0000.
Professor Alasdair Breckenridge
Chairman
Committee on Safety of Medicines
__________________________________________________________________________
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