lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder and solvent for solution for injection
▶Simulect(Novartis Pharmaceuticals UK Ltd)
Basiliximab 10 mgSimulect 10 mg powder and solvent for solution
for injection vials| 1 vialP£ 758. 69 (Hospital only)
Basiliximab 20 mgSimulect 20 mg powder and solvent for solution
for injection vials| 1 vialP£ 842. 38 (Hospital only)
IMMUNOSUPPRESSANTS›PURINE SYNTHESIS
INHIBITORS
Mycophenolate mofetil 09-Mar-2018
lINDICATIONS AND DOSE
Prophylaxis of acute rejection in renal transplantation (in
combination with a corticosteroid and ciclosporin)
(under expert supervision)
▶BY MOUTH
▶Child: 600 mg/m^2 twice daily, consult local protocol for
details; maximum 2 g per day
Prophylaxis of acute rejection in renal transplantation (in
combination with a corticosteroid and tacrolimus)
(under expert supervision)
▶BY MOUTH
▶Child: 300 mg/m^2 twice daily, consult local protocol for
details; maximum 2 g per day
Prophylaxis of acute rejection in hepatic transplantation
(in combination with a corticosteroid and ciclosporin or
tacrolimus) (under expert supervision)
▶BY MOUTH
▶Child: 10 mg/kg twice daily, increased to 20 mg/kg
twice daily, consult local protocol for details;
maximum 2 g per daylUNLICENSED USENot licensed for use in children under
2 years for the prophylaxis of acute rejection in renal
transplantation. Not licensed for use in children for the
prophylaxis of acute rejection in hepatic transplantation.
IMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE: MYCOPHENOLATE MOFETIL, MYCOPHENOLIC
ACID: UPDATED CONTRACEPTION ADVICE FOR MALE PATIENTS
(FEBRUARY 2018)
Available clinical evidence does not indicate an
increased risk of malformations or miscarriage in
pregnancies where the father was taking mycophenolate
medicines, however mycophenolate mofetil and
mycophenolic acid are genotoxic and a risk cannot be
fully excluded; for further information, see Conception
and contraception and Patient and carer advice.lCAUTIONSActive serious gastro-intestinal disease (risk of
haemorrhage, ulceration and perforation).children
(higher incidence of side-effects may call for temporary
reduction of dose or interruption).delayed graft function.
increased susceptibility to skin cancer (avoid exposure to
strong sunlight).risk of hypogammaglobulinaemia or
bronchiectasis when used in combination with other
immunosuppressants
CAUTIONS, FURTHER INFORMATION
▶Hypogammaglobulinaemia or bronchiectasisMeasure serum
immunoglobulin levels if recurrent infections develop, and
consider bronchiectasis or pulmonaryfibrosis if persistent
respiratory symptoms such as cough and dyspnoea
develop.
lINTERACTIONS→Appendix 1 : mycophenolate
lSIDE-EFFECTS
▶Common or very commonAcidosis.alopecia.anaemia.
anxiety.appetite decreased.arthralgia.asthenia.bone
marrow disorders.burping.chills.confusion.
constipation.cough.depression.diarrhoea.dizziness.
drowsiness.dyslipidaemia.dyspnoea.electrolyte
imbalance.fever.gastrointestinal discomfort.
gastrointestinal disorders.gastrointestinal haemorrhage.
gout.headache.hepatic disorders.hyperbilirubinaemia.
hyperglycaemia.hypertension.hyperuricaemia.
hypotension.increased risk of infection.insomnia.
leucocytosis.leucopenia.malaise.nausea.neoplasms.
neuromuscular dysfunction.oedema.oral disorders.pain
.pancreatitis.paraesthesia.renal impairment.respiratory
disorders.seizure.sepsis.skin reactions.tachycardia.
taste altered.thinking abnormal.thrombocytopenia.
tremor.vasodilation.vomiting.weight decreased
▶UncommonAgranulocytosis
▶Frequency not knownEndocarditis.
hypogammaglobulinaemia.malignancy.meningitis.
neutropenia.polyomavirus-associated nephropathy.
progressive multifocal leukoencephalopathy.pure red cell
aplasia
SIDE-EFFECTS, FURTHER INFORMATIONCases of pure red
cell aplasia have been reported with mycophenolate
mofetil; dose reduction or discontinuation should be
considered under specialist supervision.
lCONCEPTION AND CONTRACEPTION
Pregnancy preventionThe MHRA advises to exclude
pregnancy in females of child-bearing potential before
treatment— 2 pregnancy tests 8 – 10 days apart are
recommended. Women should use at least 1 method of
effective contraception before and during treatment, and
for 6 weeks after discontinuation— 2 methods of effective
contraception are preferred. Male patients or their female
partner should use effective contraception during
treatment and for 90 days after discontinuation.
lPREGNANCYAvoid unless no suitable alternative—
congenital malformations and spontaneous abortions
reported.
lBREAST FEEDINGManufacturer advises avoid—present in
milk inanimalstudies.
lRENAL IMPAIRMENT
Dose adjustmentsManufacturer advises consider dose
reduction if estimated glomerularfiltration rate less than
25 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTSMonitor full blood count
every week for 4 weeks then twice a month for 2 months
then every month in thefirst year (consider interrupting
treatment if neutropenia develops).
lPRESCRIBING AND DISPENSING INFORMATIONTablets and
capsules not appropriate for dose titration in children with
body surface are less than 1. 25 m^2.
lPATIENT AND CARER ADVICE
Medicines for Children leaflet: Mycophenolate mofetil for nephrotic
syndromewww.medicinesforchildren.org.uk/mycophenolate-
mofetil-for-nephrotic-syndrome
Pregnancy prevention adviceThe MHRA advises that
prescribers should ensure that female patients understand
the need to comply with the pregnancy prevention advice,
and they should be informed to seek immediate medical
attention if there is a possibility of pregnancy; male
patients planning to conceive children should be informed
of the implications of both immunosuppression and the
effect of the prescribed medications on the pregnancy.
Bone marrow suppressionPatients should be warned to
report immediately any signs or symptoms of bone marrow
suppression e.g. infection or inexplicable bruising or
bleeding.BNFC 2018 – 2019 Immune system disorders and transplantation 527
Immune system and malignant disease8