IMMUNOSUPPRESSANTS›INTERLEUKIN
INHIBITORSTocilizumab 24-May-2018
lINDICATIONS AND DOSE
Active systemic juvenile idiopathic arthritis [in
combination with methotrexate or alone if methotrexate
inappropriate, in children who have had an inadequate
response to NSAIDs and systemic corticosteroids]
▶BY INTRAVENOUS INFUSION
▶Child 2–17 years (body-weight up to 30 kg): 12 mg/kg every
2 weeks, for dose adjustments in patients with liver
enzyme abnormalities, or low absolute neutrophil or
platelet count—consult product literature, review
treatment if no improvement within 6 weeks
▶Child 2–17 years (body-weight 30 kg and above): 8 mg/kg
every 2 weeks, for dose adjustments in patients with
liver enzyme abnormalities, or low absolute neutrophil
or platelet count—consult product literature, review
treatment if no improvement within 6 weeks
Polyarticular juvenile idiopathic arthritis [in combination
with methotrexate or alone if methotrexate
inappropriate, in children who have had an inadequate
response to methotrexate]
▶BY INTRAVENOUS INFUSION
▶Child 2–17 years (body-weight up to 30 kg): 10 mg/kg every
4 weeks, for dose adjustments in patients with liver
enzyme abnormalities, or low absolute neutrophil or
platelet count—consult product literature, review
treatment if no improvement within 12 weeks
▶Child 2–17 years (body-weight 30 kg and above): 8 mg/kg
every 4 weeks, for dose adjustments in patients with
liver enzyme abnormalities, or low absolute neutrophil
or platelet count—consult product literature, review
treatment if no improvement within 12 weeks
ROACTEMRA®PRE-FILLED SYRINGE
Polyarticular juvenile idiopathic arthritis [in combination
with methotrexate or alone if methotrexate
inappropriate, in children who have had an inadequate
response to methotrexate]
▶BY SUBCUTANEOUS INJECTION
▶Child 2–17 years (body-weight up to 30 kg): 162 mg every
3 weeks, administer to abdomen, thigh or upper arm,
for dose adjustments in patients with liver enzyme
abnormalities, or low absolute neutrophil or platelet
count—consult product literature, review treatment if
no improvement within 12 weeks
▶Child 2–17 years (body-weight 30 kg and above): 162 mg
every 2 weeks, administer to abdomen, thigh or upper
arm, for dose adjustments in patients with liver
enzyme abnormalities, or low absolute neutrophil or
platelet count—consult product literature, review
treatment if no improvement within 12 weekslCONTRA-INDICATIONSDo not initiate if absolute
neutrophil count less than 26109 /litre.severe active
infection
lCAUTIONSHistory of diverticulitis.history of intestinal
ulceration.history of recurrent or chronic infection
(interrupt treatment if serious infection occurs).low
absolute neutrophil count.low platelet count.
predisposition to infection (interrupt treatment if serious
infection occurs)
CAUTIONS, FURTHER INFORMATION
▶TuberculosisPatients with latent tuberculosis should be
treated with standard therapy before starting tocilizumab.
lINTERACTIONS→Appendix 1 : monoclonal antibodieslSIDE-EFFECTS
▶Common or very commonDiarrhoea.headache.increased
risk of infection.infusion related reaction.nausea
SIDE-EFFECTS, FURTHER INFORMATIONDiscontinue if
absolute neutrophil count less than 0. 56109 /litre or
platelet count less than 506103 /microlitre).
lCONCEPTION AND CONTRACEPTIONEffective
contraception required during and for 3 months after
treatment.
lPREGNANCYManufacturer advises avoid unless
essential—toxicity inanimalstudies.
lBREAST FEEDINGManufacturer advises avoid—no
information available.
lHEPATIC IMPAIRMENTManufacturer advises caution—
consult product literature.
lRENAL IMPAIRMENT
▶With intravenous useManufacturer advises monitor renal
function closely in moderate-to-severe impairment—no
information available.
▶With subcutaneous useManufacturer advises monitor renal
function closely in severe impairment—no information
available.
lPRE-TREATMENT SCREENING
TuberculosisPatients should be evaluated for tuberculosis
before treatment.
lMONITORING REQUIREMENTS
▶Manufacturer advises monitor lipid profile 4 – 8 weeks after
starting treatment and then as indicated.
▶Manufacturer advises monitor for demyelinating
disorders.
▶Manufacturer advises monitor hepatic transaminases, and
neutrophil and platelet count at the time of the second
administration, and then as indicated.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useForintravenous infusion, manufacturer
advises for body-weight less than 30 kg, give
intermittently in Sodium chloride 0. 9 %, dilute requisite
dose to a volume of 50 mL with infusionfluid and give over
1 hour; body-weight 30 kg or greater, give intermittently in
Sodium chloride 0. 9 %, dilute requisite dose to a volume of
100 mL with infusionfluid and give over 1 hour.
▶With subcutaneous useForsubcutaneous injection,
manufacturer advises rotate injection site and avoid skin
that is tender, damaged or scarred. Patients may self-
administerRoActemra®, after appropriate training in
subcutaneous injection technique.
lPRESCRIBING AND DISPENSING INFORMATION
Manufacturer advises to record the brand name and batch
number after each administration.
lHANDLING AND STORAGEManufacturer advises protect
from light and store in a refrigerator ( 2 – 8 °C)—consult
product literature for further information regarding
storage conditions outside refrigerator and after
preparation of the infusion.
lPATIENT AND CARER ADVICEManufacturer advises
patients and their carers should be advised to seek
immediate medical attention if symptoms of infection
occur, or if symptoms of diverticular perforation such as
abdominal pain, haemorrhage, or fever accompanying
change in bowel habits occur.
An alert card should be provided.
Driving and skilled tasksManufacturer advises patients
should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Tocilizumab for the treatment of systemic juvenile idiopathic
arthritis (December 2011 )NICE TA238
Tocilizumab is recommended for the treatment of
systemic juvenile idiopathic arthritis in children aged640 Arthritis BNFC 2018 – 2019
Musculoskeletal system10