BNF for Children (BNFC) 2018-2019

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tacrolimus blood trough concentrations much higher than
the recommended maximum levels. Patients should be
monitored by echocardiography for hypertrophic
changes—consider dose reduction or discontinuation if
these occur.

lALLERGY AND CROSS-SENSITIVITYContra-indicated if
history of hypersensitivity to macrolides.


lCONCEPTION AND CONTRACEPTIONExclude pregnancy
before treatment.


lPREGNANCYAvoid unless potential benefit outweighs
risk—crosses the placenta and risk of premature delivery,
intra-uterine growth restriction, and hyperkalaemia.


lBREAST FEEDINGAvoid—present in breast milk (following
systemic administration).


lHEPATIC IMPAIRMENT
Dose adjustmentsDose reduction may be necessary in
severe impairment.


lMONITORING REQUIREMENTS
▶After initial dosing, and for maintenance treatment,
tacrolimus doses should be adjusted according to whole-
blood concentration. Monitor whole blood-tacrolimus
trough concentration (especially during episodes of
diarrhoea)—consult local treatment protocol for details.
▶Monitor blood pressure, ECG (for hypertrophic changes—
risk of cardiomyopathy), fasting blood-glucose
concentration, haematological and neurological (including
visual) and coagulation parameters, electrolytes, hepatic
and renal function.


lDIRECTIONS FOR ADMINISTRATIONForcontinuous
intravenous infusionover 24 hours, dilute to a
concentration of 4 – 100 micrograms/mL with Glucose 5 %
orSodium Chloride 0. 9 %, to a total volume between
20 – 500 mL. Tacrolimus is incompatible with PVC.


lPRESCRIBING AND DISPENSING INFORMATIONThe RCPCH
and NPPG recommend that, when a liquid special of
tacrolimus is required, the following strength is used:
5 mg/ 5 mL.
PROGRAF®INFUSIONIntravenous route should only be
used if oral route is inappropriate.


lPATIENT AND CARER ADVICEAvoid excessive exposure to
UV light including sunlight.
Medicines for Children leaflet: Tacrolimus for prevention of
transplant rejectionwww.medicinesforchildren.org.uk/
tacrolimus-for-prevention-of-transplant-rejection
Driving and skilled tasksMay affect performance of skilled
tasks (e.g. driving).


lNATIONAL FUNDING/ACCESS DECISIONS


NICE decisions
▶Immunosuppressive therapy for kidney transplant in children
and young people (October 2017 )NICE TA482
Immediate-release tacrolimus, 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. Tacrolimus granules
for oral suspension (Modigraf®) should be used only if the
manufacturer provides it at the same price or lower than
that agreed with the Commercial Medicines Unit. 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/TA482
▶Immunosuppressive therapy for kidney transplant in children
and young people (October 2017 )NICE TA482
Prolonged-release tacrolimus is not recommended as an
initial treatment to prevent organ rejection in patients
having a kidney transplant. 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/TA482
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (December
2010 ) that tacrolimus granules for suspension (Modigraf®)
are accepted for restricted use within NHS Scotland in
patients for whom tacrolimus is an appropriate choice of
immunosuppressive therapy and where small changes (less
than 500 micrograms) in dosing increments are required
(such as, in paediatric patients) or in seriously ill patients
who are unable to swallow tacrolimus capsules.

lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Granules
CAUTIONARY AND ADVISORY LABELS13, 23
▶Modigraf(Astellas Pharma Ltd)
Tacrolimus (as Tacrolimus monohydrate)
200 microgramModigraf 0. 2 mg granules sachets sugar-free|
50 sachetP£ 71. 30 DT = £ 71. 30
Tacrolimus (as Tacrolimus monohydrate) 1 mgModigraf 1 mg
granules sachets sugar-free| 50 sachetP£ 356. 65 DT = £ 356. 65
Solution for infusion
EXCIPIENTS:May contain Polyoxyl castor oils
▶Prograf(Astellas Pharma Ltd)
Tacrolimus 5 mg per 1 mlPrograf 5 mg/ 1 ml solution for infusion
ampoules| 10 ampouleP£ 584. 51
Capsule
CAUTIONARY AND ADVISORY LABELS 23
▶Adoport(Sandoz Ltd)
Tacrolimus 500 microgramAdoport 0. 5 mg capsules|
50 capsuleP£ 42. 92 DT = £ 61. 88
Tacrolimus 1 mgAdoport 1 mg capsules| 50 capsuleP£ 55. 69
DT = £ 80. 28 | 100 capsuleP£ 111. 36
Tacrolimus 5 mgAdoport 5 mg capsules| 50 capsuleP£ 205. 74
DT = £ 296. 58
▶Capexion(Mylan)
Tacrolimus 500 microgramCapexion 0. 5 mg capsules|
50 capsuleP£ 52. 50 DT = £ 61. 88
▶Prograf(Astellas Pharma Ltd)
Tacrolimus 500 microgramPrograf 500 microgram capsules|
50 capsuleP£ 61. 88 DT = £ 61. 88
Tacrolimus 1 mgPrograf 1 mg capsules| 50 capsuleP£ 80. 28
DT = £ 80. 28 | 100 capsuleP£ 160. 54
Tacrolimus 5 mgPrograf 5 mg capsules| 50 capsuleP£ 296. 58
DT = £ 296. 58
▶Tacni(Teva UK Ltd)
Tacrolimus 500 microgramTacni 0. 5 mg capsules|
50 capsuleP£ 50. 48 DT = £ 61. 88
Tacrolimus 1 mgTacni 1 mg capsules| 50 capsuleP£ 65. 49 DT =
£ 80. 28 | 100 capsuleP£ 130. 99
Tacrolimus 5 mgTacni 5 mg capsules| 50 capsuleP£ 242. 01 DT
=£ 296. 58

BNFC 2018 – 2019 Immune system disorders and transplantation 525


Immune system and malignant disease

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