Erythropoietins

Treatment with epoetin is commissioned by NHS England.

Although clinically indistinguishable the prescription must specify which brand and product is required.

To achieve the optimum dosage of epoetin any ferritin, folate and B12 deficiencies should be corrected first. Patients should be screened prior to prescribing.

Erythropoietins are accepted for the management of anaemia which develops during treatment with peginterferon and ribavirin for chronic hepatitis C virus infection (see Commissioning Policy for more details)

Please refer to NICE TA323 Erythropoiesis stimulating agents (epoetin and darbepoetin) for treating anaemia in people with cancer having chemotherapy (November 2014).

MHRA Drug Safety Update (January 2018): Recombinant human erythropoietins: very rare risk of severe cutaneous adverse reactions (SCARs):

• Be aware of very rare cases of severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), in patients receiving recombinant human erythropoietins (r-HuEPOs); some cases were fatal
• More severe cases were recorded with long-acting r-HuEPOs (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta)
• Advise patients of the signs and symptoms of severe skin reactions at initiation and instruct them to stop treatment and seek immediate medical attention if they develop widespread rash and blistering; these rashes often occur following fever or flu-like symptoms
• Discontinue all r-HuEPOs permanently in patients who develop severe cutaneous adverse reactions such as SJS or TEN

Darbepoetin alfa

• Prefilled syringes 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms
• SureClick 20, 40, 60, 80, 100, 150, 300, 500 micrograms

Epoetin alfa

• Prefilled syringes 1000, 2000, 3000, 4000, 5000, 6000, 8000, 10,000, 20,000, 40,000iu

Notes

1. For use by University Hospitals Plymouth NHS Trust
2. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
3. Epoetin alfa and pure red cell aplasia (PRCA) – Contraindication of subcutaneous administration to patients with chronic renal failure.
   1. The subcutaneous route should not be used to administer Epoetin alfa to patients with chronic renal failure. If intravenous administration of Epoetin alfa is not feasible, appropriate alternative treatment should be given.
   2. PRCA 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.
   3. If PRCA is diagnosed, therapy with Epoetin alfa 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.

Epoetin beta

• Prefilled syringes 500, 1000, 2000, 3000, 4000, 5000, 6000, 10,000, 20,000, 30,000iu
• Reco-Pen 10,000, 20,000iu

Epoetin zeta

• Prefilled syringes 1000, 2000, 3000, 4000, 5000, 6000, 8000, 10,000, 20,000, 30,000, 40,000iu

Notes

1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.

Hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI)

Roxadustat

• Tablet 20mg, 50mg, 70mg, 100mg, 150mg

Notes

1. NICE TA807: Roxadustat (Evrenzo) is recommended as an option for treating symptomatic anaemia associated with chronic kidney disease (CKD) in adults (July 2022) only if:
   1. they have stage 3 to 5 CKD with no iron deficiency and
   2. they are not on dialysis at the start of treatment and
   3. the company provides roxadustat according to the commercial agreement

Iron overload

Deferasirox

• Tablets 90mg, 180mg, 360mg

Desferrioxamine

• Powder for solution for injection vial 500mg, 2g

Notes

1. Patients in primary care receiving desferrioxamine (chelating agent used in iron overload states) do so through secondary care via Home Healthcare arrangements. Each patient and their GP should be given a contact number for further help and support.

Paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

Crovalimab

• Solution for injection vials 340mg/2ml

Notes

1. NICE TA1019: Crovalimab (Piasky) is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria in people 12 years and over who weigh 40kg or more. It is recommended for people who:
   1. have haemolysis with clinical symptoms indicating high disease activity
   2. are clinically stable after having a complement component 5 inhibitor for at least the past 6 months.
   3. It is only recommended if the company provides it according to the commercial arrangement (November 2024).

Eculizumab

• Concentrate for I/V infusion 10mg/ml, 30ml vial

Notes

1. Please refer to: NICE HST1 Eculizumab recommended for treating atypical haemolytic uraemic syndrome (January 2015). NHS England commissioned

Iptacopan

• Capsules 200mg

Notes

1. NICE TA1000: Iptacopan (Fabhalta) is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults with haemolytic anaemia, only if the company provides it according to the commercial arrangement (September 2024).

Pegcetacoplan

• Solution for infusion vials 1.08mg/20ml

Notes

1. NICE TA778: Pegcetacoplan (Aspaveli) is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults who have anaemia after at least 3 months of treatment with a C5 inhibitor (March 2022)
   1. It is recommended only if the company provides pegcetacoplan according to the commercial arrangement

Ravulizumab

• Concentrate for solution for infusion vials 300mg/30ml, 1,100mg/11ml

Notes

1. NICE TA698: Ravulizumab (Ultomiris) is recommended, within its marketing authorisation, as an option for treating paroxysmal nocturnal haemoglobinuria in adults (May 2021):
   1. with haemolysis with clinical symptoms suggesting high disease activity, or
   2. whose disease is clinically stable after having eculizumab for at least 6 months, and
   3. the company provides it according to the commercial arrangement
2. NICE TA710: Ravulizumab (Ultomiris) is recommended, within its marketing authorisation, as an option for treating atypical haemolytic uraemic syndrome (aHUS) in people weighing 10kg or more (June 2021):
   1. who have not had a complement inhibitor before, or
   2. whose disease has responded to at least 3 months of eculizumab treatment, and
   3. only if the company provides ravulizumab according to the commercial arrangement