lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for infusion
ELECTROLYTES:May contain Sodium
▶Yervoy(Bristol-Myers Squibb Pharmaceuticals Ltd)A
Ipilimumab 5 mg per 1 mlYervoy 50 mg/ 10 ml concentrate for
solution for infusion vials| 1 vialP£ 3 , 750. 00 (Hospital only)
Yervoy 200 mg/ 40 ml concentrate for solution for infusion vials|
1 vialP£ 15 , 000. 00 (Hospital only)IMMUNOSUPPRESSANTS›MONOCLONAL
ANTIBODIES›ANTI-LYMPHOCYTEAnti-lymphocyte monoclonal f
antibodies
lDRUG ACTIONThe anti-lymphocyte monoclonal
antibodies cause lysis of B lymphocytes.IMPORTANT SAFETY INFORMATION
All anti-lymphocyte monoclonal antibodies should be
given under the supervision of an experienced specialist,
in an environment where full resuscitation facilities are
immediately available.lSIDE-EFFECTS
▶Common or very commonAlopecia.anaemia.arthralgia.
asthenia.back pain.chills.constipation.cough.cytokine
release syndrome.depression.diarrhoea.dyspnoea.fever
.flushing.headache.hypersensitivity (discontinue
permanently).hypertension.hypotension.increased risk
of infection.infusion related reaction.leucopenia.nausea
.neutropenia.pruritus.sweat changes.tachycardia.
thrombocytopenia.tumour lysis syndrome.vomiting
▶UncommonProgressive multifocal leukoencephalopathy
▶Rare or very rareHepatitis B reactivation
▶Frequency not knownAnaphylactic reaction
SIDE-EFFECTS, FURTHER INFORMATION
Infusion-related side-effectsIn rare cases infusion
reactions may be fatal. Infusion-related side-effects occur
predominantly during thefirst infusion. Patients should
receive premedication before administration of anti-
lymphocyte monoclonal antibodies to reduce these effects
—consult product literature for details of individual
regimens. The infusion may have to be stopped
temporarily and the infusion-related effects treated—
consult product literature for appropriate management.
Cytokine release syndromeFatalities following severe
cytokine release syndrome (characterised by severe
dyspnoea) and associated with features of tumour lysis
syndrome have occurred after infusions of anti-
lymphocyte monoclonal antibodies. Patients with a high
tumour burden as well as those with pulmonary
insufficiency or infiltration are at increased risk and should
be monitored very closely (and a slower rate of infusion
considered).
lPRE-TREATMENT SCREENINGAll patients should be
screened for hepatitis B before treatment.eiiiiFaboveRituximab 21-Feb-2018
lINDICATIONS AND DOSE
Post-transplantation lymphoproliferative disease (under
expert supervision)|Non-Hodgkin’s lymphoma (under
expert supervision)|Hodgkin’s lymphoma (under expert
supervision)|Severe cases of resistant immune
modulated disease including idiopathic
thrombocytopenia purpura, haemolytic anaemia, and
systemic lupus erythematosus (under expert
supervision)
▶BY INTRAVENOUS INFUSION
▶Child:Patients should receive premedication before
each dose (consult product literature for details)
(consult local protocol)lUNLICENSED USENot licensed for use in children.
lCAUTIONSHistory of cardiovascular disease; in adults
exacerbation of angina, arrhythmia, and heart failure have
been reported.transient hypotension occurs frequently
during infusion (anti-hypertensives may need to be
withheld for 12 hours before infusion)
CAUTIONS, FURTHER INFORMATION
▶Hepatitis B infection and reactivationHepatitis B infection and
reactivation (including fatal cases) have been reported in
patients takingrituximab. Patients with positive hepatitis
B serology should be referred to a liver specialist for
monitoring and initiation of antiviral therapy before
treatment initiation; treatment should not be initiated in
patients with evidence of current hepatitis B infection
until the infection has been adequately treated. Patients
should be closely monitored for clinical and laboratory
signs of active hepatitis B infection during treatment and
for up to a year following the last infusion (consult product
literature).
For full details on cautions, consult product literature or
local treatment protocol.
lINTERACTIONS→Appendix 1 : monoclonal antibodies
lSIDE-EFFECTS
▶Common or very commonAngioedema.anxiety.appetite
decreased.arrhythmias.bone marrow disorders.bursitis.
cancer pain.cardiac disorder.chest pain.conjunctivitis.
cough aggravated.dizziness.dysphagia.ear pain.
gastrointestinal discomfort.gastrointestinal disorders.
hearing impairment.hepatitis B.hypercholesterolaemia.
hyperglycaemia.hypocalcaemia.increased risk of
infection.insomnia.lacrimation disorder.malaise.
migraine.multi organ failure.muscle tone increased.
myalgia.myocardial infarction.nerve disorders.
neutropenia.oedema.oral disorders.oropharyngeal pain
.osteoarthritis.pain.postural hypotension.respiratory
disorders.sensation abnormal.sepsis.skin reactions.
throat irritation.vasodilation.weight decreased
▶UncommonAsthma.coagulation disorder.haemolytic
anaemia.heart failure.hypoxia.ischaemic heart disease.
lymphadenopathy.taste altered
▶Rare or very rareFacial paralysis.hypersensitivity.renal
failure.Stevens-Johnson syndrome (discontinue).toxic
epidermal necrolysis (discontinue).vasculitis.vision
disorders
▶Frequency not knownHypogammaglobulinaemia.
posterior reversible encephalopathy syndrome (PRES).
psychiatric disorder.seizure
SIDE-EFFECTS, FURTHER INFORMATIONAssociated with
infections, sometimes severe, including tuberculosis,
septicaemia, and hepatitis B reactivation.
Progressive multifocal leucoencephalopathy has been
reported in association with rituximab; patients should be
monitored for cognitive, neurological, or psychiatric signs
and symptoms. If progressive multifocal530 Antibody responsive malignancy BNFC 2018 – 2019
Immune system and malignant disease8