BNF for Children (BNFC) 2018-2019

over 4 weeks or if haemoglobin concentration approaches or exceeds 12 g/ 100 mL; if haemoglobin concentration continues to rise, despite dose reduction, suspend treatment until haemoglobin concentration decreases and then restart at a dose approximately 25 % lower than the previous dose; maximum 720 units/kg per week Prevention of anaemias of prematurity in neonates ▶BY SUBCUTANEOUS INJECTION ▶Neonate up to 33 weeks corrected gestational age (body- weight 0.75–1.5 kg): 250 units/kg 3 times a week preferably started within 3 days of birth and continued for 6 weeks, using single-dose unpreserved injection.

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE (MAY 2015) EPOETIN BETA (NEORECORMON):

INCREASED RISK OF RETINOPATHY IN PRETERM INFANTS CANNOT

BE EXCLUDED

There is a possible increased risk of retinopathy in premature infants, when epoetin beta is used for preventing anaemia of prematurity. When using epoetin beta in preterm infants: .consider the benefits and risks of treatment, including the possible risk of retinopathy, .monitor the infant for features of retinopathy, and .advise parents or carers that their baby’s eyes will be carefully monitored for any ill effects.

lINTERACTIONS→Appendix 1 : epoetin beta

lSIDE-EFFECTSSevere cutaneous adverse reactions
(SCARs)

lPREGNANCYNo evidence of harm. Benefits probably
outweigh risk of anaemia and of blood transfusion in
pregnancy.

lBREAST FEEDINGUnlikely to be present in milk. Minimal
effect on infant.

lHEPATIC IMPAIRMENTManufacturers advise caution in
chronic hepatic failure.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
EXCIPIENTS:May contain Phenylalanine
▶NeoRecormon(Roche Products Ltd)
Epoetin beta 1667 unit per 1 mlNeoRecormon 500 units/ 0. 3 ml
solution for injection pre-filled syringes| 6 pre-filled disposable
injectionP£ 21. 05
Epoetin beta 6667 unit per 1 mlNeoRecormon 2 , 000 units/ 0. 3 ml
injectionP£ 84. 17
injectionP£ 126. 25
NeoRecormon 5 , 000 units/ 0. 3 ml solution for injection pre-filled
syringes| 6 pre-filled disposable injectionP£ 210. 42

eiiiiF 563

Epoetin zeta

lINDICATIONS AND DOSE Symptomatic anaemia associated with chronic renal failure in patients on haemodialysis ▶BY INTRAVENOUS INJECTION ▶Child (body-weight up to 10 kg):Initially 50 units/kg 3 times a week, adjusted according to response, adjusted in steps of 25 units/kg 3 times a week, dose to be adjusted at intervals of at least 4 weeks; maintenance 75 – 150 units/kg 3 times a week, to be administered over 1 – 5 minutes, avoid increasing haemoglobin concentration at a rate exceeding 2 g/ 100 mL over 4 weeks ▶Child (body-weight 10–30 kg):Initially 50 units/kg 3 times a week, adjusted according to response, adjusted in steps of 25 units/kg 3 times a week, dose to be adjusted at intervals of at least 4 weeks; maintenance 60 – 150 units/kg 3 times a week, to be administered over 1 – 5 minutes, avoid increasing haemoglobin concentration at a rate exceeding 2 g/ 100 mL over 4 weeks ▶Child (body-weight 31 kg and above):Initially 50 units/kg 3 times a week, adjusted according to response, adjusted in steps of 25 units/kg 3 times a week, dose to be adjusted at intervals of at least 4 weeks; maintenance 30 – 100 units/kg 3 times a week, to be administered over 1 – 5 minutes, avoid increasing haemoglobin concentration at a rate exceeding 2 g/ 100 mL over 4 weeks

lINTERACTIONS→Appendix 1 : epoetin zeta lSIDE-EFFECTS ▶Common or very commonAsthenia.dizziness ▶UncommonIntracranial haemorrhage ▶Rare or very rareAngioedema ▶Frequency not knownAneurysm.cerebrovascular insufficiency.hypertensive encephalopathy.myocardial infarction.myocardial ischaemia lPREGNANCYNo evidence of harm. Benefits probably outweigh risk of anaemia and of blood transfusion in pregnancy. lBREAST FEEDINGUnlikely to be present in milk. Minimal effect on infant. lHEPATIC IMPAIRMENTManufacturers advise caution in chronic hepatic failure. lPRESCRIBING AND DISPENSING INFORMATIONEpoetin zeta is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, seeBiological medicinesandBiosimilar medicines, under Guidance on prescribing p. 1.

lMEDICINAL FORMS There can be variation in the licensing of different medicines containing the same drug. Solution for injection EXCIPIENTS:May contain Phenylalanine ▶Retacrit(Pfizer Ltd) Epoetin zeta 3333 unit per 1 mlRetacrit 2 , 000 units/ 0. 6 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 57. 70 (Hospital only) Retacrit 3 , 000 units/ 0. 9 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 86. 55 (Hospital only) Retacrit 1 , 000 units/ 0. 3 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 28. 85 (Hospital only) Epoetin zeta 10000 unit per 1 mlRetacrit 6 , 000 units/ 0. 6 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 173. 09 (Hospital only) Retacrit 10 , 000 units/ 1 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 288. 48 (Hospital only) Retacrit 8 , 000 units/ 0. 8 ml solution for injection pre-filled syringes| 6 pre-filled disposable injectionP£ 230. 79 (Hospital only)

BNFC 2018 – 2019 Hypoplastic, haemolytic, and renal anaemias 567

Blood and nutrition

9

BNF for Children (BNFC) 2018-2019

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE (MAY 2015) EPOETIN BETA (NEORECORMON):

INCREASED RISK OF RETINOPATHY IN PRETERM INFANTS CANNOT

BE EXCLUDED

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