thrombosis.fatigue.haemorrhage.hemiparesis.
hypotension.increased risk of infection.infertility.
leukoencephalopathy.malaise.menstrual disorder.
metabolic change.mood altered.mucositis.myalgia.
neoplasms.nephropathy.osteoporosis.pancreatitis.
pericardial effusion.pericarditis.photosensitivity
reaction.pulmonary oedema.renal failure.seizure.
sepsis.severe cutaneous adverse reactions (SCARs).skin
ulcer.sperm abnormalities.sudden death.telangiectasia.
tinnitus.vaginal ulceration.vasculitis.vision blurred
▶With oral useEncephalopathy
SIDE-EFFECTS, FURTHER INFORMATIONGive folic acid to
reduce side-effects. Folic acid decreases mucosal and
gastrointestinal side-effects of methotrexate and may
prevent hepatotoxicity; there is no evidence of a reduction
in haematological side-effects.
Withdraw treatment if ulcerative stomatitis develops—
may befirst sign of gastro-intestinal toxicity.
Treatment with folinic acid (as calcium folinate) may be
required in acute toxicity.
lCONCEPTION AND CONTRACEPTIONEffective
contraception required during and for at least 3 months
after treatment in men or women.
lPREGNANCYAvoid (teratogenic; fertility may be reduced
during therapy but this may be reversible).
lBREAST FEEDINGDiscontinue breast-feeding—present in
milk.
lHEPATIC IMPAIRMENTWhen used for malignancy, avoid in
severe hepatic impairment—consult local treatment
protocol for details. Avoid with hepatic impairment in
non-malignant conditions—dose-related toxicity.
lRENAL IMPAIRMENTRisk of nephrotoxicity at high doses.
Avoid in severe impairment.
Dose adjustmentsReduce dose.
lPRE-TREATMENT SCREENINGExclude pregnancy before
treatment.
Patients should have full blood count and renal and liver
function tests before starting treatment.
Check immunity to varicella-zoster and consider
vaccination before initiating therapy.
lMONITORING REQUIREMENTSFull blood count and liver
function tests repeated fortnightly for at least thefirst
4 weeks of treatment and at this frequency after any
change in dose until therapy stabilised, thereafter
monthly; renal function tests should be performed
regularly during treatment.
lPRESCRIBING AND DISPENSING INFORMATIONFolinic acid
following methotrexate administration helps to prevent
methotrexate-induced mucositis and myelosuppression.
The licensed routes of administration for parenteral
preparations vary—further information can be found in
the product literature for the individual preparations.
lPATIENT AND CARER ADVICEPatients and their carers
should be warned to report immediately the onset of any
feature of blood disorders (e.g. sore throat, bruising, and
mouth ulcers), liver toxicity (e.g. nausea, vomiting,
abdominal discomfort and dark urine), and respiratory
effects (e.g. shortness of breath).
Children and carers should be advised to avoid self-
medication with over-the-counter ibuprofen
Children and their carers should be counselled on the
dose and use of NSAIDs.
Medicines for Children leaflet: Methotrexate for skin conditions
http://www.medicinesforchildren.org.uk/methotrexate-for-skin-
conditions
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution, solution
for injection
Tablet
▶Methotrexate (Non-proprietary)
Methotrexate 2.5 mgMethotrexate 2. 5 mg tablets| 24 tabletP
£ 1. 23 – £ 3. 75 | 28 tabletP£ 3. 82 DT = £ 1. 44 | 100 tabletP
£ 5. 14 – £ 14. 01
Methotrexate 10 mgMethotrexate 10 mg tablets| 100 tabletP
£ 57. 21 DT = £ 49. 33
▶Maxtrex(Pfizer Ltd)
Methotrexate 2.5 mgMaxtrex 2. 5 mg tablets| 24 tabletP£ 2. 39
| 100 tabletP£ 9. 96
Methotrexate 10 mgMaxtrex 10 mg tablets| 100 tabletP
£ 45. 16 DT = £ 49. 33
Solution for injection
▶Methotrexate (Non-proprietary)
Methotrexate (as Methotrexate sodium) 2.5 mg per
1mlMethotrexate 5 mg/ 2 ml solution for injection vials| 5 vialP
£ 36. 00 (Hospital only)
Methotrexate (as Methotrexate sodium) 25 mg per
1mlMethotrexate 1 g/ 40 ml solution for injection vials| 1 vialP
£ 1 , 452. 55 (Hospital only)| 1 vialP£ 44. 57
Methotrexate 500 mg/ 20 ml solution for injection vials| 1 vialP
£ 48. 00 – £ 726. 28 (Hospital only)| 1 vialP£ 25. 07
Methotrexate 50 mg/ 2 ml solution for injection vials| 1 vialP
£ 2. 62 – £ 72. 63 | 5 vialP£ 35. 00 (Hospital only)
Methotrexate 200 mg/ 8 ml solution for injection vials| 1 vialP
£ 10. 02
Methotrexate (as Methotrexate sodium) 100 mg per
1mlMethotrexate 1 g/ 10 ml solution for injection vials| 1 vialP
£ 85. 00 (Hospital only)
▶Methofill(Accord Healthcare Ltd)
Methotrexate 50 mg per 1 mlMethofill 12. 5 mg/ 0. 25 ml solution for
injection pre-filled injector| 1 pre-filled disposable injectionP
£ 14. 85 DT = £ 16. 50
Methofill 22. 5 mg/ 0. 45 ml solution for injection pre-filled injector|
1 pre-filled disposable injectionP£ 16. 61 DT = £ 18. 45
Methofill 30 mg/ 0. 6 ml solution for injection pre-filled injector| 1 pre-
filled disposable injectionP£ 17. 06 DT = £ 18. 95
Methofill 27. 5 mg/ 0. 55 ml solution for injection pre-filled injector|
1 pre-filled disposable injectionP£ 17. 00 DT = £ 18. 89
Methofill 7. 5 mg/ 0. 15 ml solution for injection pre-filled injector|
1 pre-filled disposable injectionP£ 13. 37 DT = £ 14. 85
Methofill 20 mg/ 0. 4 ml solution for injection pre-filled injector| 1 pre-
filled disposable injectionP£ 16. 06 DT = £ 17. 84
Methofill 10 mg/ 0. 2 ml solution for injection pre-filled injector| 1 pre-
filled disposable injectionP£ 13. 76 DT = £ 15. 29
Methofill 15 mg/ 0. 3 ml solution for injection pre-filled injector| 1 pre-
filled disposable injectionP£ 14. 91 DT = £ 16. 57
Methofill 17. 5 mg/ 0. 35 ml solution for injection pre-filled injector|
1 pre-filled disposable injectionP£ 15. 75 DT = £ 17. 50
Methofill 25 mg/ 0. 5 ml solution for injection pre-filled injector| 1 pre-
filled disposable injectionP£ 16. 63 DT = £ 18. 48
▶Metoject PEN(medac UK)
Methotrexate 50 mg per 1 mlMetoject PEN 30 mg/ 0. 6 ml solution for
injection pre-filled pen| 1 pre-filled disposable injectionP£ 16. 56
DT = £ 18. 95
Metoject PEN 22. 5 mg/ 0. 45 ml solution for injection pre-filled pen|
1 pre-filled disposable injectionP£ 16. 11 DT = £ 18. 45
Metoject PEN 12. 5 mg/ 0. 25 ml solution for injection pre-filled pen|
1 pre-filled disposable injectionP£ 14. 35 DT = £ 16. 50
Metoject PEN 20 mg/ 0. 4 ml solution for injection pre-filled pen| 1 pre-
filled disposable injectionP£ 15. 56 DT = £ 17. 84
Metoject PEN 17. 5 mg/ 0. 35 ml solution for injection pre-filled pen|
1 pre-filled disposable injectionP£ 15. 25 DT = £ 17. 50
Metoject PEN 7. 5 mg/ 0. 15 ml solution for injection pre-filled pen|
1 pre-filled disposable injectionP£ 12. 87 DT = £ 14. 85
Metoject PEN 10 mg/ 0. 2 ml solution for injection pre-filled pen| 1 pre-
filled disposable injectionP£ 13. 26 DT = £ 15. 29
Metoject PEN 27. 5 mg/ 0. 55 ml solution for injection pre-filled pen|
1 pre-filled disposable injectionP£ 16. 50 DT = £ 18. 89
Metoject PEN 25 mg/ 0. 5 ml solution for injection pre-filled pen| 1 pre-
filled disposable injectionP£ 16. 13 DT = £ 18. 48
Metoject PEN 15 mg/ 0. 3 ml solution for injection pre-filled pen| 1 pre-
filled disposable injectionP£ 14. 41 DT = £ 16. 57BNFC 2018 – 2019 Cytotoxic responsive malignancy 545
Immune system and malignant disease8