.has not responded to standard systemic therapy, such as
ciclosporin, methotrexate or phototherapy, or these
options are contra-indicated or not tolerated.
If the psoriasis has not responded adequately, stop
treatment at 16 weeks. An adequate response is defined as
a 75 % reduction in PASI score from the start of treatment.
Patients currently receiving ustekinumab who do not
meet the above criteria and whose treatment was started
within the NHS before this guidance was published, should
have the option to continue treatment until they and their
clinician consider it appropriate to stop.
http://www.nice.org.uk/guidance/TA455lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Solution for injection
CAUTIONARY AND ADVISORY LABELS 10
▶Stelara(Janssen-Cilag Ltd)
Ustekinumab 90 mg per 1 mlStelara 90 mg/ 1 ml solution for
injection pre-filled syringes| 1 pre-filled disposable injectionP
£ 2 , 147. 00
Stelara 45 mg/ 0. 5 ml solution for injection vials| 1 vialP
£ 2 , 147. 00
Stelara 45 mg/ 0. 5 ml solution for injection pre-filled syringes| 1 pre-
filled disposable injectionP£ 2 , 147. 00
RETINOID AND RELATED DRUGS
Acitretin
lDRUG ACTIONAcitretin is a metabolite of etretinate.
lINDICATIONS AND DOSE
Severe extensive psoriasis resistant to other forms of
therapy (under expert supervision)|Palmoplantar
pustular psoriasis (under expert supervision)|Severe
congenital ichthyosis (under expert supervision)
▶BY MOUTH
▶Child 1 month–11 years: 0. 5 mg/kg once daily; increased
if necessary to^1 mg/kg once daily, to be taken with
food or milk, careful monitoring of musculoskeletal
development required; maximum 35 mg per day
▶Child 12–17 years:Initially 25 – 30 mg daily for
2 – 4 weeks, then adjusted according to response to
25 – 50 mg daily, increased to up to 75 mg daily, dose
only increased to 75 mg daily for short periods in
psoriasis
Severe Darier’s disease (keratosis follicularis) (under
expert supervision)
▶BY MOUTH
▶Child 1 month–11 years: 0. 5 mg/kg once daily; increased
if necessary to 1 mg/kg once daily, to be taken with
food or milk, careful monitoring of musculoskeletal
development required; maximum 35 mg per day
▶Child 12–17 years:Initially 10 mg daily for 2 – 4 weeks,
then adjusted according to response to 25 – 50 mg daily
Harlequin ichthyosis (under expert supervision)
▶BY MOUTH
▶Neonate: 0. 5 mg/kg once daily; increased if necessary to
1 mg/kg once daily, to be taken with food or milk,
careful monitoring of musculoskeletal development
required.lCONTRA-INDICATIONSHyperlipidaemia
lCAUTIONSAvoid excessive exposure to sunlight and
unsupervised use of sunlamps.diabetes (can alter glucose
tolerance—initial frequent blood glucose checks).do not
donate blood during and for 2 years after stopping therapy
(teratogenic risk).in children use only in exceptional
circumstances and monitor growth parameters and bone
development (premature epiphyseal closure reported).
investigate atypical musculoskeletal symptoms
lINTERACTIONS→Appendix 1 : retinoids
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.arthralgia.
brittle nails.conjunctivitis.diarrhoea.dry mouth.
gastrointestinal disorder.haemorrhage.hair texture
abnormal.headache.increased risk of infection.mucosal
abnormalities.myalgia.nausea.oral disorders.peripheral
oedema.skin reactions.thirst.vomiting.xerophthalmia
▶UncommonDizziness.hepatic disorders.photosensitivity
reaction.vision disorders
▶Rare or very rareBone pain.exostosis.idiopathic
intracranial hypertension.peripheral neuropathy
▶Frequency not knownAngioedema.capillary leak
syndrome.drowsiness.dysphonia.flushing.glucose
tolerance impaired.granuloma.hearing impairment.
hyperhidrosis.malaise.pyogenic granuloma.retinoic acid
syndrome.taste altered
SIDE-EFFECTS, FURTHER INFORMATION
ExostosisSkeletal hyperostosis and extra-osseous
calcification reported following long-term treatment with
etretinate (of which acitretin is a metabolite) and
premature epiphyseal closure in children.
Benign intracranial hypertensionDiscontinue if severe
headache, nausea, vomiting, or visual disturbances occur.
lCONCEPTION AND CONTRACEPTIONEffective
contraception must be used.
Pregnancy preventionIn females of child-bearing potential
(including those with a history of infertility), exclude
pregnancy up to 3 days before treatment, every month
during treatment, and every 1 – 3 months for 3 years after
stopping treatment. Treatment should be started on day 2
or 3 of menstrual cycle. Females of child-bearing age must
practise effective contraception for at least 1 month before
starting treatment, during treatment, and for at least
3 years after stopping treatment. Females should be
advised to use at least 1 method of contraception, but
ideally they should use 2 methods of contraception. Oral
progestogen-only contraceptives are not considered
effective. Barrier methods should not be used alone but
can be used in conjunction with other contraceptive
methods. Females should be advised to seek medical
attention immediately if they become pregnant during
treatment or within 3 years of stopping treatment. They
should also be advised to avoid alcohol during treatment
and for 2 months after stopping treatment.
lPREGNANCYAvoid—teratogenic.
lBREAST FEEDINGAvoid.
lHEPATIC IMPAIRMENTAvoid in severe impairment—risk of
further impairment.
lRENAL IMPAIRMENTAvoid in severe impairment;
increased risk of toxicity.
lMONITORING REQUIREMENTS
▶Monitor serum-triglyceride and serum-cholesterol
concentrations before treatment, 1 month after starting,
then every 3 months.
▶Check liver function at start, at least every 4 weeks forfirst
2 months and then every 3 months.
lPRESCRIBING AND DISPENSING INFORMATION
Prescribing for women of child-bearing potentialEach
prescription for acitretin should be limited to a supply of
up to 30 days’treatment and dispensed within 7 days of
the date stated on the prescription.
lPATIENT AND CARER ADVICEFemales of child-bearing
potential must be advised on pregnancy prevention.
A patient information leaflet should be provided.BNFC 2018 – 2019 Eczema and psoriasis 749
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