Severe psoriasis unresponsive to conventional therapy
(specialist use only)
▶BY MOUTH
▶Child 2–17 years:Initially 200 micrograms/kg once
weekly (max. per dose 10 mg), then increased if
necessary to 400 micrograms/kg once weekly (max. per
dose 25 mg), adjusted according to response, stop
treatment if inadequate response after 3 months at the
optimum doselUNLICENSED USEMetoject®is licensed for use in children
over 3 years for polyarticular forms of juvenile idiopathic
arthritis; other preparations not licensed for use in
children for non-malignant conditions.IMPORTANT SAFETY INFORMATION
Note that the dose is aweeklydose. To avoid error with
low-dose methotrexate, it is recommended that:
.the child or their carer is carefully advised of thedose
andfrequencyand the reason for taking methotrexate
and any other prescribed medication (e.g. folic acid);
.only one strength of methotrexate tablet (usually
2. 5 mg) is prescribed and dispensed;
.the prescription and the dispensing label clearly show
the dose and frequency of methotrexate
administration;
.the child or their carer is 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).lCONTRA-INDICATIONSActive infection (in non-malignant
conditions).ascites.immunodeficiency syndromes (in
non-malignant conditions).significant pleural effusion
lCAUTIONSPhotosensitivity—psoriasis lesions aggravated
by UV radiation (skin ulceration reported).diarrhoea.
extreme caution in blood disorders (avoid if severe).peptic
ulceration.risk of accumulation in pleural effusion or
ascites—drain before treatment.ulcerative colitis.
ulcerative stomatitis
CAUTIONS, FURTHER INFORMATION
▶Blood countBone marrow suppression can occur abruptly;
factors likely to increase toxicity include advanced age,
renal impairment, and concomitant use with another anti-
folate drug (e.g. trimethoprim). A clinically significant
drop in white cell count or platelet count calls for
immediate withdrawal of methotrexate and introduction
of supportive therapy.
▶Gastro-intestinal toxicityWithdraw treatment if stomatitis
develops—may befirst sign of gastro-intestinal toxicity.
▶Liver toxicityPersistent 2 – fold rise in liver transaminases
may necessitate dose reduction or rarely discontinuation;
abrupt withdrawal should be avoided as this can lead to
diseaseflare.
▶Pulmonary toxicityAcute pulmonary toxicity is rare in
children treated for juvenile idiopathic arthritis, but
children and carers should seek medical attention if
dyspnoea, cough or fever develops; discontinue if
pneumonitis suspected.
lINTERACTIONS→Appendix 1 : methotrexate
lSIDE-EFFECTS
▶Common or very common
▶With intramuscular and subcutaneous useAnaemia.appetite
decreased.chest pain.cough.diarrhoea.drowsiness.
dyspnoea.fatigue.fever.gastrointestinal discomfort.
headache.leucopenia.malaise.nausea.oral disorders.
respiratory disorders.skin reactions.throat complaints.
thrombocytopenia.vomiting▶With intrathecal useArachnoiditis.fever.headache.nausea
.necrotising demyelinating leukoencephalopathy.
neurotoxicity.vomiting
▶With intravenous useAbdominal distress.fever.headache.
leucopenia.nausea.oral disorders.vomiting
▶With oral useAnaemia.appetite decreased.diarrhoea.
drowsiness.fatigue.fever.gastrointestinal discomfort.
headache.increased risk of infection.leucopenia.nausea
.oral disorders.respiratory disorders.skin reactions.
throat ulcer.thrombocytopenia.vomiting
▶Uncommon
▶With intramuscular useAgranulocytosis.alopecia.arthralgia
.bone marrow disorders.confusion.cystitis.depression.
diabetes mellitus.drug toxicity.dysuria.gastrointestinal
disorders.haemorrhage.healing impaired.hepatic
disorders.increased risk of infection.lipoatrophy.local
reaction.myalgia.neoplasms.osteoporosis.pain.
paraesthesia.photosensitivity reaction.rheumatoid
arthritis aggravated.seizure.severe cutaneous adverse
reactions (SCARs).sterile abscess.vasculitis.vertigo.
vulvovaginal disorders
▶With oral useAgranulocytosis.alopecia.arthralgia.bone
marrow disorders.chills.confusion.cystitis.depression.
diabetes mellitus.dysuria.gastrointestinal disorders.
haemorrhage.healing impaired.hepatic disorders.
myalgia.neoplasms.nephropathy.osteoporosis.
photosensitivity reaction.rheumatoid arthritis aggravated
.seizure.severe cutaneous adverse reactions (SCARs).
vasculitis.vertigo.vulvovaginal disorders
▶With subcutaneous useAgranulocytosis.alopecia.arthralgia
.bone marrow disorders.confusion.cystitis.depression.
diabetes mellitus.drug toxicity.dysuria.gastrointestinal
disorders.haemorrhage.healing impaired.hepatic
disorders.increased risk of infection.myalgia.neoplasms
.osteoporosis.pain.paraesthesia.photosensitivity
reaction.rheumatoid arthritis aggravated.seizure.severe
cutaneous adverse reactions (SCARs).vasculitis.vertigo.
vulvovaginal disorders
▶Rare or very rare
▶With intramuscular and subcutaneous useApnoea.asthma-
like conditions.azotaemia.conjunctivitis.eosinophilia.
gynaecomastia.hypotension.immune deficiency.
infertility.influenza like illness.insomnia.
lymphadenopathy.meningism.meningitis aseptic.
menstrual disorder.mood swings.muscle weakness.nail
discolouration.neutropenia.oligozoospermia.paralysis.
pericardial disorders.pericarditis.proteinuria.
reactivation of infection.renal impairment.retinopathy.
sepsis.sexual dysfunction.stress fracture.taste altered.
telangiectasia.thromboembolism.visual impairment
▶With intravenous useAnaemia.bone marrow depression.
gastrointestinal disorders.hepatic disorders.
hypogammaglobulinaemia.necrosis.respiratory disorders
.skin reactions.thrombocytopenia
▶With oral useAzotaemia.brain oedema.cognitive
impairment.conjunctivitis.cough.dyspnoea.
eosinophilia.gynaecomastia.hypotension.immune
deficiency.infertility.insomnia.lymphadenopathy.
meningitis aseptic.menstrual disorder.mood altered.
muscle weakness.nail discolouration.neutropenia.
oligozoospermia.pain.pancreatitis.paresis.pericardial
disorders.pericarditis.proteinuria.psychosis.radiation
injuries.renal impairment.retinopathy.sensation
abnormal.sepsis.sexual dysfunction.speech impairment
.stress fracture.taste metallic.telangiectasia.tinnitus.
visual impairment
▶Frequency not known
▶With intramuscular and subcutaneous useLeukoencephalopathy
▶With intravenous useAlopecia.aphasia.appetite decreased.
arthralgia.azotaemia.chills.cognitive disorder.
conjunctivitis.cystitis.defective oogenesis.diabetes
mellitus.diarrhoea.dizziness.drowsiness.embolism and544 Cytotoxic responsive malignancy BNFC 2018 – 2019
Immune system and malignant disease8