IMMUNOSUPPRESSANTS›TUMOR NECROSIS
FACTOR ALPHA (TNF-a) INHIBITORS
Infliximab 31-May-2016
lINDICATIONS AND DOSE
Severe active Crohn’s disease
▶BY INTRAVENOUS INFUSION
▶Child 6–17 years:Initially 5 mg/kg, then 5 mg/kg after
2 weeks, then 5 mg/kg after 4 weeks, then maintenance
5 mg/kg every 8 weeks, interval between maintenance
doses adjusted according to response; discontinue if no
response within 10 weeks of initial dose
Fistulating Crohn’s disease
▶BY INTRAVENOUS INFUSION
▶Child 6–17 years:Initially 5 mg/kg, then 5 mg/kg after
2 weeks, followed by 5 mg/kg after 4 weeks, if condition
has responded consult product literature for guidance
on further doses
Severe active ulcerative colitis
▶BY INTRAVENOUS INFUSION
▶Child 6–17 years:Initially 5 mg/kg, then 5 mg/kg after
2 weeks, followed by 5 mg/kg after 4 weeks, then
5 mg/kg every 8 weeks, discontinue if no response
within 8 weeks of initial doselUNLICENSED USENot licensed forfistulating Crohn’s
disease in children.
IMPORTANT SAFETY INFORMATION
Adequate resuscitation facilities must be available when
infliximab is used.lCONTRA-INDICATIONSModerate or severe heart failure.
severe infections
lCAUTIONSDemyelinating disorders (risk of exacerbation).
dermatomyositis.development of malignancy.hepatitis B
virus—monitor for active infection.history of malignancy
.history of prolonged immunosuppressant or PUVA
treatment in patients with psoriasis.mild heart failure
(discontinue if symptoms develop or worsen).
predisposition to infection (discontinue if new serious
infection develops).risk of delayed hypersensitivity
reactions if drug-free interval exceeds 16 weeks (re-
administration after interval exceeding 16 weeks not
recommended)
CAUTIONS, FURTHER INFORMATION
▶TuberculosisManufacturer advises to evaluate patients for
active and latent tuberculosis before treatment. Active
tuberculosis should be treated with standard treatment for
at least 2 months before starting infliximab. If latent
tuberculosis is diagnosed, treatment should be started
before commencing treatment with infliximab. Patients
who have previously received adequate treatment for
tuberculosis can start infliximab but should be monitored
every 3 months for possible recurrence. In patients
without active tuberculosis but who were previously not
treated adequately, chemoprophylaxis should ideally be
completed before starting infliximab. In patients at high
risk of tuberculosis who cannot be assessed by tuberculin
skin test, chemoprophylaxis can be given concurrently
with infliximab. Patients should be advised to seek medical
attention if symptoms suggestive of tuberculosis develop
(e.g. persistent cough, weight loss and fever).
▶Hypersensitivity reactionsHypersensitivity reactions
(including fever, chest pain, hypotension, hypertension,
dyspnoea, transient visual loss, pruritus, urticaria, serum
sickness-like reactions, angioedema, anaphylaxis)
reported during or within 1 – 2 hours after infusion (risk
greatest duringfirst or second infusion or in patients who
discontinue other immunosuppressants). Manufacturer
advises prophylactic antipyretics, antihistamines, or
hydrocortisone may be administered.
lINTERACTIONS→Appendix 1 : monoclonal antibodies
lSIDE-EFFECTS
▶Common or very commonAbscess.alopecia.anaemia.
arrhythmias.arthralgia.chest pain.chills.constipation.
decreased leucocytes.depression.diarrhoea.dizziness.
dyspnoea.eye inflammation.fatigue.fever.
gastrointestinal discomfort.gastrointestinal disorders.
haemorrhage.headache.hepatic disorders.hyperhidrosis
.hypertension.hypotension.increased risk of infection.
infusion related reaction.insomnia.lymphadenopathy.
myalgia.nausea.neutropenia.oedema.pain.
palpitations.respiratory disorders.sensation abnormal.
sepsis.skin reactions.vasodilation.vertigo
▶UncommonAnxiety.cheilitis.cholecystitis.confusion.
drowsiness.healing impaired.heart failure.
hypersensitivity.lupus-like syndrome.lymphocytosis.
memory loss.neoplasms.nerve disorders.pancreatitis.
peripheral ischaemia.pulmonary oedema.seborrhoea.
seizure.syncope.thrombocytopenia.thrombophlebitis
▶Rare or very rareAgranulocytosis.circulatory collapse.
cyanosis.demyelinating disorders.granuloma.
haemolytic anaemia.hepatitis B reactivation.meningitis.
pancytopenia.pericardial effusion.sarcoidosis.severe
cutaneous adverse reactions (SCARs).transverse myelitis.
vasculitis.vasospasm
▶Frequency not knownBone fracture.dermatomyositis
exacerbated.hepatosplenic T-cell lymphoma (increased
risk in inflammatory bowel disease).myocardial infarction
.myocardial ischaemia.ulcerative colitis aggravated.
vision loss
lCONCEPTION AND CONTRACEPTIONManufacturer advises
adequate contraception during and for at least 6 months
after last dose.
lPREGNANCYUse only if essential.
lBREAST FEEDINGAmount probably too small to be
harmful.
lPRE-TREATMENT SCREENING
TuberculosisPatients should be evaluated for tuberculosis
before treatment.
lMONITORING REQUIREMENTS
▶Monitor for infection before, during, and for 6 months
after treatment.
▶All patients should be observed carefully for 1 – 2 hours
after infusion and resuscitation equipment should be
available for immediate use (risk of hypersensitivity
reactions).
▶Monitor for symptoms of delayed hypersensitivity if re-
administered after a prolonged period.
▶Manufacturer advises periodic skin examination for non-
melanoma skin cancer, particularly in patients with risk
factors.
lDIRECTIONS FOR ADMINISTRATIONForintravenous infusion
reconstitute each 100 -mg vial of powder with 10 mL Water
for Injections; to dissolve, gently swirl vial without
shaking; allow to stand for 5 minutes; dilute required dose
with Sodium Chloride 0. 9 %toafinal volume of 250 mL and
give through a low protein-bindingfilter ( 1. 2 micron or
less) over at least 2 hours; start infusion within 3 hours of
reconstitution.
lPRESCRIBING AND DISPENSING INFORMATIONInfliximab is
a biological medicine. Biological medicines must be
prescribed and dispensed by brand name, seeBiological
medicinesandBiosimilar medicines, under Guidance on
prescribing p. 1.
lPATIENT AND CARER ADVICE
TuberculosisPatients and carers should be advised to seek
medical attention if symptoms suggestive of tuberculosis
(e.g. persistent cough, weight loss, and fever) develop.BNFC 2018 – 2019 Inflammatory bowel disease 33
Gastro-intestinal system1