lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Immunosuppressive therapy for kidney transplant in children
and young people (October 2017 )NICE TA482
Mycophenolate mofetil, when used as part of an
immunosuppressive regimen, is recommended as an initial
option to prevent organ rejection in patients having a
kidney transplant. Treatment should be started with the
least expensive product, but if this is not suitable, an
alternative dosage form may be given. The use of
mycophenolate mofetil with tacrolimus is outside the
terms of the marketing authorisation. If this combination
is prescribed, the prescriber should follow relevant
professional guidance, taking full responsibility for the
decision. Informed consent should be obtained and
documented.
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
it appropriate to stop.
http://www.nice.org.uk/guidance/TA482lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension
Tablet
▶Mycophenolate mofetil (Non-proprietary)
Mycophenolate mofetil 500 mgMycophenolate mofetil 500 mg
tablets| 50 tabletP£ 42. 50 DT = £ 5. 66
▶CellCept(Roche Products Ltd)
Mycophenolate mofetil 500 mgCellCept 500 mg tablets|
50 tabletP£ 82. 26 DT = £ 5. 66
▶Myfenax(Teva UK Ltd)
Mycophenolate mofetil 500 mgMyfenax 500 mg tablets|
50 tabletP£ 78. 15 DT = £ 5. 66
Oral suspension
EXCIPIENTS:May contain Aspartame
▶CellCept(Roche Products Ltd)
Mycophenolate mofetil 200 mg per 1 mlCellCept 1 g/ 5 ml oral
suspension sugar-free| 175 mlP£ 115. 16 DT = £ 115. 16
Capsule
▶Mycophenolate mofetil (Non-proprietary)
Mycophenolate mofetil 250 mgMycophenolate mofetil 250 mg
capsules| 100 capsuleP£ 82. 26 DT = £ 82. 26
▶CellCept(Roche Products Ltd)
Mycophenolate mofetil 250 mgCellCept 250 mg capsules|
100 capsuleP£ 82. 26 DT = £ 82. 26
▶Myfenax(Teva UK Ltd)
Mycophenolate mofetil 250 mgMyfenax 250 mg capsules|
100 capsuleP£ 78. 15 DT = £ 82. 26Malignant disease
1 Antibody responsive
malignancy
ANTINEOPLASTIC DRUGS›MONOCLONAL
ANTIBODIESGemtuzumab ozogamicin 21-May-2018
lDRUG ACTIONGemtuzumab ozogamicin is a monoclonal
antibody that binds to CD 33 -expressing tumour cells to
induce cell cycle arrest and apoptotic cell death.lINDICATIONS AND DOSE
CD 33 -positive acute myeloid leukaemia (specialist use
only)
▶BY INTRAVENOUS INFUSION
▶Child 15–17 years:(consult product literature)lCAUTIONSAdverse-risk cytogenetics (consider benefits
and risks of treatment, consult product literature).
haematopoietic stem cell transplantation (increased risk of
hepatotoxicity).pre-medication recommended to
minimise adverse reactions
CAUTIONS, FURTHER INFORMATION
▶Pre-medicationSerious infusion-related reactions can occur
and gemtuzumab ozogamicin should only be administered
when appropriately trained staff and resuscitation
facilities are immediately available; manufacturer advises
pre-medication with a corticosteroid, paracetamol and
antihistamine 1 hour prior to dosing, and to take
appropriate measures to help prevent the development of
tumour lysis-related hyperuricaemia—consult product
literature.
lSIDE-EFFECTS
▶Common or very commonAnaemia.appetite decreased.
ascites.chills.constipation.decreased leucocytes.
diarrhoea.dyspnoea.fatigue.fever.gastrointestinal
discomfort.gastrointestinal disorders.haemorrhage.
headache.hepatic disorders.hyperbilirubinaemia.
hyperglycaemia.hypertension.hypotension.infection.
infusion related reaction (including fatal cases).multi
organ failure.nausea.neutropenia.oedema.
pancytopenia.sinusoidal obstruction syndrome.skin
reactions.stomatitis.tachycardia.thrombocytopenia.
tumour lysis syndrome (including fatal cases).vomiting
▶Frequency not knownInterstitial pneumonia
SIDE-EFFECTS, FURTHER INFORMATIONInfusion-related
reactions (including fatal cases) can occur during thefirst
24 hours after administration. Manufacturer advises
interrupt treatment immediately and treat as clinically
indicated (consult product literature); permanent
discontinuation should be strongly considered in patients
who develop signs and symptoms of anaphylaxis.
lCONCEPTION AND CONTRACEPTIONManufacturer advises
women of childbearing potential should use 2 methods of
effective contraception during treatment and for at least
7 months after the last dose; male patients should use 2
methods of effective contraception during treatment and
for at least 4 months after the last dose if their partner is of
childbearing potential. See also Pregnancy and
reproductive function in Cytotoxic drugs p. 531.
lPREGNANCYManufacturer advises avoid unless potential
benefit outweighs risk—toxicity inanimalstudies. See also
Pregnancy and reproductive function in Cytotoxic drugs
p. 531.528 Malignant disease BNFC 2018 – 2019
Immune system and malignant disease8