lBREAST FEEDINGAvoid—present in breast milk (following
systemic administration).
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
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Tacrolimus and pimecrolimus for atopic eczema (August
2004 )NICE TA82
Topical tacrolimus is an option for atopic eczema not
controlled by maximal topical corticosteroid treatment or
if there is a risk of important corticosteroid side-effects
(particularly skin atrophy).
Topical tacrolimus is recommended as an option for the
second-line treatment for moderate to severe atopic
eczema in adults and children over 2 years.Tacrolimus
should be used within its licensed indications.
http://www.nice.org.uk/guidance/TA82
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (March
2010 ) that tacrolimus 0. 03 % ointment (Protopic®)is
accepted for restricted use within NHS Scotland for the
prevention offlares in children aged 2 to 15 years with
moderate-to-severe atopic eczema in accordance with the
licensed indications; initiation of treatment is restricted to
doctors (including general practitioners) with a specialist
interest and experience in treating atopic eczema with
immunomodulatory therapy.
TheScottish Medicines Consortiumhas advised (April
2010 ) that tacrolimus 0. 1 % ointment (Protopic®)is
accepted for restricted use within NHS Scotland for the
prevention offlares in patients aged 16 years and over with
moderate-to-severe atopic eczema in accordance with the
licensed indications; initiation of treatment is restricted to
doctors (including general practitioners) with a specialist
interest and experience in treating atopic eczema with
immunomodulatory therapy.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Ointment
CAUTIONARY AND ADVISORY LABELS4, 11, 28
EXCIPIENTS:May contain Beeswax
▶Protopic(LEO Pharma)
Tacrolimus (as Tacrolimus monohydrate) 300 microgram per
1 gramProtopic 0. 03 % ointment| 30 gramP£ 23. 33 DT =
£ 23. 33 | 60 gramP£ 42. 55 DT = £ 42. 55
Tacrolimus (as Tacrolimus monohydrate) 1 mg per
1 gramProtopic 0. 1 % ointment| 30 gramP£ 25. 92 DT = £ 25. 92
| 60 gramP£ 47. 28 DT = £ 47. 28IMMUNOSUPPRESSANTS›INTERLEUKIN
INHIBITORSUstekinumab 03-Oct-2017
lINDICATIONS AND DOSE
Moderate-to-severe plaque psoriasis that has not
responded to other systemic treatments or
photochemotherapy, or when these treatments cannot
be used because of intolerance or contra-indications
(specialist use only)
▶BY SUBCUTANEOUS INJECTION
▶Child 12–17 years (body-weight up to 60 kg):Initially
750 micrograms/kg, then 750 micrograms/kg after
4 weeks, then 750 micrograms/kg every 12 weeks,
consider discontinuation if no response within
28 weeks, consult product literature for advice on
calculating volume of injection to be given▶Child 12–17 years (body-weight 60–100 kg):Initially
45 mg, then 45 mg after 4 weeks, then 45 mg every
12 weeks, consider discontinuation if no response
within^28 weeks
▶Child 12–17 years (body-weight 100 kg and above):Initially
90 mg, then 90 mg after 4 weeks, then 90 mg every
12 weeks, consider discontinuation if no response
within 28 weekslCONTRA-INDICATIONSActive infection
lCAUTIONSDevelopment of malignancy.history of
malignancy.predisposition to infection.start appropriate
treatment if widespread erythema and skin exfoliation
develop, and stop ustekinumab treatment if exfoliative
dermatitis suspected
CAUTIONS, FURTHER INFORMATION
▶TuberculosisActive tuberculosis should be treated with
standard treatment for at least 2 months before starting
ustekinumab. Patients who have previously received
adequate treatment for tuberculosis can start ustekinumab
but should be monitored every 3 months for possible
recurrence. In patients without active tuberculosis but
who were previously not treated adequately,
chemoprophylaxis should ideally be completed before
starting ustekinumab. In patients at high risk of
tuberculosis who cannot be assessed by tuberculin skin
test, chemoprophylaxis can be given concurrently with
ustekinumab.
lINTERACTIONS→Appendix 1 : monoclonal antibodies
lSIDE-EFFECTS
▶Common or very commonArthralgia.asthenia.back pain.
diarrhoea.dizziness.headache.increased risk of infection
.myalgia.nausea.oropharyngeal pain.skin reactions.
vomiting
▶UncommonDepression.facial paralysis.hypersensitivity
(may be delayed).nasal congestion
lCONCEPTION AND CONTRACEPTIONManufacturer advises
effective contraception during treatment and for 15 weeks
after stopping treatment.
lPREGNANCYAvoid.
lBREAST FEEDINGManufacturer advises avoid—present in
milk inanimalstudies.
lPRE-TREATMENT SCREENING
TuberculosisPatients should be evaluated for tuberculosis
before treatment.
lMONITORING REQUIREMENTS
▶Monitor for non-melanoma skin cancer, especially in
patients with a history of PUVA treatment or prolonged
immunosuppressant therapy, or those over 60 years of age.
▶Monitor for signs and symptoms of exfoliative dermatitis
or erythrodermic psoriasis.
lPATIENT AND CARER ADVICE
Exfoliative dermatitisPatients should be advised to seek
prompt medical attention if symptoms suggestive of
exfoliative dermatitis or erythrodermic psoriasis (such as
increased redness and shedding of skin over a larger area
of the body) develop.
TuberculosisPatients should be advised to seek medical
attention if symptoms suggestive of tuberculosis (e.g.
persistent cough, weight loss, and fever) develop.
lNATIONAL FUNDING/ACCESS DECISIONS
NICE decisions
▶Adalimumab, etanercept and ustekinumab for treating plaque
psoriasis in children and young people (July 2017 )NICE TA455
Ustekinumab is recommended as an option for treating
plaque psoriasis in children and young people aged
12 years or older, only if the disease:
.is severe, as defined by a total PASI of 10 or more,and748 Inflammatory skin conditions BNFC 2018 – 2019
Skin13