▶ Polytar Scalp (GlaxoSmithKline Consumer Healthcare)
Coal tar solution 40 mg per 1 ml Polytar Scalp shampoo | 150 ml G £3.46 DT = £3.46
▶ Psoriderm (Dermal Laboratories Ltd)
Coal tar distilled 25 mg per 1 ml Psoriderm scalp lotion | 250 ml p £4.74 DT = £4.74
Coal tar with calamine 15-Jan-2019
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253.
Psoriasis | Chronic atopic eczema (occasionally)
▶ Adult: Apply 1–2 times a day
MHRA/CHM ADVICE (UPDATED DECEMBER 2018): EMOLLIENTS:
NEW INFORMATION ABOUT RISK OF SEVERE AND FATAL BURNS
WITH PARAFFIN-CONTAINING AND PARAFFIN-FREE EMOLLIENTS
See Emollient and barrier preparations p. 1221.
l PRESCRIBING AND DISPENSING INFORMATION When
prepared extemporaneously, the BP states Calamine and
Coal Tar Ointment BP, consists of calamine 12.5 g, strong
coal tar solution 2.5 g, zinc oxide 12.5 g, hydrous wool fat
25 g, white soft paraffin 47.5 g.
l MEDICINAL FORMS Forms available from special-order
manufacturers include: ointment
Coal tar with coconut oil and salicylic
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253, salicylic acid p. 1286.
Scaly scalp disorders | Psoriasis | Seborrhoeic dermatitis |
▶ Child: Apply daily as required
▶ Adult: Apply daily as required
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Capasal (Dermal Laboratories Ltd)
Salicylic acid 5 mg per 1 gram, Coal tar distilled 10 mg per 1 gram,
Coconut oil 10 mg per 1 gram Capasal Therapeutic shampoo | 250 ml p £4.69
Coal tar with dithranol and salicylic
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253, dithranol p. 1253, salicylic
Subacute and chronic psoriasis
▶ Child: Apply up to twice daily
▶ Adult: Apply up to twice daily
▶ In children Psorin ® is licensed for use in children (age range
not specified by manufacturer).
l MEDICINAL FORMS Forms available from special-order
manufacturers include: ointment
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253.
▶ Child: Apply 1–2 times a day, cream to be applied to
▶ Adult: Apply 1–2 times a day, cream to be applied to
1254 Inflammatory skin conditions BNF 78
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Isopropyl palmitate, propylene glycol
▶ Psoriderm (Dermal Laboratories Ltd)
Lecithin 4 mg per 1 gram, Coal tar distilled 60 mg per
1 gram Psoriderm cream | 225 ml p £9.42 DT = £9.42
Coal tar with salicylic acid 16-Jan-2019
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253, salicylic acid p. 1286.
Psoriasis | Chronic atopic eczema
▶ Adult: Apply 1–2 times a day
MHRA/CHM ADVICE (UPDATED DECEMBER 2018): EMOLLIENTS:
NEW INFORMATION ABOUT RISK OF SEVERE AND FATAL BURNS
WITH PARAFFIN-CONTAINING AND PARAFFIN-FREE EMOLLIENTS
See Emollient and barrier preparations p. 1221.
l PRESCRIBING AND DISPENSING INFORMATION When
prepared extemporaneously, the BP states Coal Tar and
Salicylic Acid Ointment, BP consists of coal tar 2 g,
salicylic acid 2 g, emulsifying wax 11.4 g, white soft
paraffin 19 g, coconut oil 54 g, polysorbate ’80’ 4 g, liquid
l MEDICINAL FORMS Forms available from special-order
manufacturers include: ointment
Coal tar with salicylic acid and
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253, salicylic acid p. 1286.
Scaly scalp disorders including psoriasis, eczema,
seborrhoeic dermatitis and dandruff
▶ INITIALLY TO THE SKIN USING SCALP OINTMENT
▶ Child 6–11 years: Medical supervision required
▶ Child 12–17 years: Apply once weekly as required,
alternatively (to the skin) apply daily for the first
3–7 days (if severe), shampoo off after 1 hour
▶ Adult: Apply once weekly as required, alternatively (to
the skin) apply daily for the first 3–7 days (if severe),
Scaly scalp disorders including psoriasis, eczema,
seborrhoeic dermatitis and dandruff
▶ TO THE SKIN USING SCALP OINTMENT
▶ Child 6–11 years: Medical supervision required
▶ Child 12–17 years: Apply as required, alternatively apply
daily for the first 3–7 days (if severe), shampoo off after
▶ Adult: Apply as required, alternatively apply daily for
the first 3–7 days (if severe), shampoo off after 1 hour
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and
▶ Cocois (RPH Pharmaceuticals AB)
Salicylic acid 20 mg per 1 gram, Sulfur precipitated 40 mg per
1 gram, Coal tar solution 120 mg per 1 gram Cocois ointment | 40 gram G £6.22 | 100 gram G £11.69
Salicylic acid 20 mg per 1 gram, Sulfur precipitated 40 mg per
1 gram, Coal tar solution 120 mg per 1 gram Sebco ointment | 40 gram G £6.20 | 100 gram G £11.67
Coal tar with zinc oxide 16-Jan-2019
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, coal tar p. 1253.
Psoriasis | Chronic atopic eczema
▶ Child: Apply 1–2 times a day
▶ Adult: Apply 1–2 times a day
MHRA/CHM ADVICE (UPDATED DECEMBER 2018): EMOLLIENTS:
NEW INFORMATION ABOUT RISK OF SEVERE AND FATAL BURNS
WITH PARAFFIN-CONTAINING AND PARAFFIN-FREE EMOLLIENTS
See Emollient and barrier preparations p. 1221.
l PRESCRIBING AND DISPENSING INFORMATION No
preparations available—when prepared
extemporaneously, the BP states Zinc and Coal Tar Paste,
BP consists of zinc oxide 6%, coal tar 6%, emulsifying wax
5%, starch 38%, yellow soft paraffin 45%.
l MEDICINAL FORMS Forms available from special-order
manufacturers include: ointment, paste
IMMUNOSUPPRESSANTS › CALCINEURIN
Short-term treatment of mild to moderate atopic eczema
(including flares) when topical corticosteroids cannot be
used (initiated by a specialist)
▶ Adult: Apply twice daily until symptoms resolve (stop
treatment if eczema worsens or no response after
Short-term treatment of facial, flexural, or genital
psoriasis in patients unresponsive to, or intolerant of
other topical therapy (initiated by a specialist)
▶ Adult: Apply twice daily until symptoms resolve
(maximum duration of treatment 4 weeks)
patients unresponsive to, or intolerant of other topical
l CONTRA-INDICATIONS Application to malignant or
potentially malignant skin lesions . application under
occlusion . congenital epidermal barrier defects . contact
with eyes . contact with mucous membranes . generalised
erythroderma . immunodeficiency . infection at treatment
l CAUTIONS Alcohol consumption (risk of facial flushing
and skin irritation). avoid other topical treatments except
emollients at treatment site . UV light (avoid excessive
exposure to sunlight and sunlamps)
l INTERACTIONS → Appendix 1: pimecrolimus
BNF 78 Eczema and psoriasis 1255
▶ Common or very common Increased risk of infection
▶ Rare or very rare Skin discolouration
▶ Frequency not known Skin papilloma
l PREGNANCY Manufacturer advises avoid; toxicity in
animal studies following systemic administration.
l BREAST FEEDING Manufacturer advises caution; ensure
infant does not come in contact with treated areas.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Tacrolimus and pimecrolimus for atopic eczema (August
Topical pimecrolimus is an option for atopic eczema not
controlled by maximal topical corticosteroid treatment or
if there is a risk of important corticosteroid side-effects
Topical pimecrolimus is recommended for moderate
atopic eczema on the face and neck of children aged
2–16 years. Pimecrolimus should be used within its
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 4, 11, 28
EXCIPIENTS: May contain Benzyl alcohol, cetostearyl alcohol (including
cetyl and stearyl alcohol), propylene glycol
▶ Elidel (Meda Pharmaceuticals Ltd)
l DRUG ACTION Tacrolimus is a calcineurin inhibitor.
Short-term treatment of moderate to severe atopic
eczema (including flares) in patients unresponsive to, or
intolerant of conventional therapy (initiated by a
▶ Adult: Apply twice daily until lesion clears (consider
other treatment if eczema worsens or no improvement
after 2 weeks), initially 0.1% ointment to be applied
thinly, reduce frequency to once daily or strength of
ointment to 0.03% if condition allows
Prevention of flares in patients with moderate to severe
atopic eczema and 4 or more flares a year who have
responded to initial treatment with topical tacrolimus
▶ Adult: Apply twice weekly, 0.1% ointment to be applied
thinly, with an interval of 2–3 days between
applications, use short-term treatment regimen during
an acute flare; review need for preventative therapy
Short-term treatment of facial, flexural, or genital
psoriasis in patients unresponsive to, or intolerant of
other topical therapy (initiated under specialist
▶ Adult: Apply twice daily until symptoms resolve, 0.1%
ointment to be applied thinly, reduce to once daily or
switch to 0.03% ointment if condition allows,
maximum duration of treatment 4 weeks
l UNLICENSED USE Short-term treatment of facial, flexural,
or genital psoriasis is unlicensed.
l CONTRA-INDICATIONS Application to malignant or
potentially malignant skin lesions . application under
occlusion . avoid contact with eyes . avoid contact with
l CAUTIONS UV light (avoid excessive exposure to sunlight
l INTERACTIONS → Appendix 1: tacrolimus
▶ Common or very common Alcohol intolerance . increased
risk of infection . sensation abnormal . skin reactions
▶ Frequency not known Malignancy . neoplasms
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated if
history of hypersensitivity to macrolides.
l PREGNANCY Manufacturer advises avoid unless essential;
toxicity in animal studies following systemic
l BREAST FEEDING Avoid—present in breast milk (following
l HEPATIC IMPAIRMENT Manufacturer advises caution in
l PATIENT AND CARER ADVICE Avoid excessive exposure to
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Tacrolimus and pimecrolimus for atopic eczema (August
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
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.
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2010)
that tacrolimus 0.1 % ointment (Protopic ®) is accepted for
restricted use within NHS Scotland for the prevention of
indications; initiation of treatment is restricted to doctors
(including general practitioners) with a specialist interest
and experience in treating atopic eczema with
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 4, 11, 28
EXCIPIENTS: May contain Beeswax
▶ Tacrolimus (Non-proprietary)
Tacrolimus (as Tacrolimus monohydrate) 1 mg per
1 gram Tacrolimus 0.1% ointment | 30 gram P £20.74–£25.92 DT
= £25.92 | 60 gram P £37.82–£47.28 DT = £47.28
Tacrolimus (as Tacrolimus monohydrate) 300 microgram per
1 gram Protopic 0.03% ointment | 30 gram P £23.33 DT =
£23.33 | 60 gram P £42.55 DT = £42.55
Tacrolimus (as Tacrolimus monohydrate) 1 mg per
1 gram Protopic 0.1% ointment | 30 gram P £25.92 DT = £25.92
| 60 gram P £47.28 DT = £47.28
1256 Inflammatory skin conditions BNF 78
IMMUNOSUPPRESSANTS › INTERLEUKIN
l DRUG ACTION Brodalumab is a recombinant human
monoclonal antibody that binds with high affinity to
interleukin-17RA and blocks the activity of proinflammatory cytokines.
Moderate-to-severe plaque psoriasis (under expert
▶ Adult: 210 mg every week for 3 doses, followed by
210 mg every 2 weeks, consider discontinuing
treatment if no response after 16 weeks
l CONTRA-INDICATIONS Active Crohn’s disease . clinically
l CAUTIONS Chronic infection . history of Crohn’s disease
(monitor for exacerbations). history of depressive
disorders (discontinue if new or worsening symptoms
develop). history of recurrent infection . history of suicidal
ideation or behaviour (discontinue if new or worsening
before starting treatment with brodalumab.
l INTERACTIONS → Appendix 1: monoclonal antibodies
▶ Frequency not known Meningitis cryptococcal . suicidal
l CONCEPTION AND CONTRACEPTION Manufacturer advises
that women of childbearing potential should use effective
contraception during treatment and for at least 12 weeks
l PREGNANCY Manufacturer advises avoid—limited
l BREAST FEEDING Manufacturer advises avoid—no
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
to take the syringe out of the refrigerator at least
30 minutes before administration, and to avoid injecting
into areas of the skin that are tender, bruised, or affected
by psoriasis. Patients may self-administer Kyntheum®,
after appropriate training in subcutaneous injection
l PRESCRIBING AND DISPENSING INFORMATION Brodalumab
is a biological medicine. Biological medicines must be
prescribed and dispensed by brand name, see Biological
medicines and Biosimilar medicines, under Guidance on
prescribing p. 1; manufacturer advises to record the brand
name and batch number after each administration.
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C) and protect from light—consult
product literature for further information regarding
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be given training in
subcutaneous injection technique. Manufacturer advises
patients and their carers should seek medical advice if new
or worsening symptoms of depression, suicidal ideation, or
behaviour occur; they should also be advised to report
signs and symptoms of infection.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Brodalumab for treating moderate to severe plaque psoriasis
Brodalumab is recommended as an option for treating
plaque psoriasis in adults, only if:
. the disease is severe, as defined by a total Psoriasis Area
and Severity Index (PASI) of 10 or more and a
Dermatology Life Quality Index (DLQI) of more than 10,
. the disease has not responded to other systemic
therapies, including ciclosporin, methotrexate and
PUVA (psoralen and long-wave ultraviolet A radiation),
or these options are contra-indicated or not tolerated,
. the manufacturer provides the drug with the discount
agreed in the patient access scheme.
Stop brodalumab at 12 weeks if the psoriasis has not
responded adequately, defined as:
. a 75% reduction in the PASI score (PASI 75) from when
. a 50% reduction in the PASI score (PASI 50) and a 5-
point reduction in DLQI from when treatment started.
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
www.nice.org.uk/guidance/ta511
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (updated
May 2018) that brodalumab (Kyntheum®) is accepted for
restricted use within NHS Scotland for the treatment of
moderate-to-severe plaque psoriasis in adults who have
failed to respond to standard systemic therapies (including
ciclosporin, methotrexate and phototherapy), are
intolerant to, or have a contra-indication to these
treatments. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Brodalumab 140 mg per 1 ml Kyntheum 210mg/1.5ml solution for
injection pre-filled syringes | 2 pre-filled disposable injection P £1,280.00
l DRUG ACTION Dupilumab is a recombinant human
monoclonal antibody that inhibits interleukin-4 and
interleukin-13 signaling; these cytokines are involved in
Moderate-to-severe atopic eczema (specialist use only)
▶ Adult: Initially 600 mg, followed by 300 mg every
2 weeks, the initial dose should be administered as two
consecutive 300 mg injections at different injection
sites, review treatment if no response after 16 weeks
l CAUTIONS Asthma—consult product literature . helminth
BNF 78 Eczema and psoriasis 1257
▶ Helminth infection Dupilumab may influence the immune
response to helminth infections. Resolve pre-existing
infection before initiating treatment; suspend treatment if
resistant infection develops during therapy.
l INTERACTIONS → Appendix 1: monoclonal antibodies
▶ Common or very common Eosinophilia . eye inflammation . eye pruritus . headache . oral herpes
▶ Rare or very rare Serum sickness-like reaction
SIDE-EFFECTS, FURTHER INFORMATION Side-effects
reported with or without concomitant corticosteroids.
l PREGNANCY Manufacturer advises use only if potential
benefit outweighs risk—limited information available.
l BREAST FEEDING Manufacturer advises avoid—no
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
to inject into the thigh or abdomen (except for the 5 cm
around the navel), or upper arm (if not self-administered);
rotate injection site and avoid skin that is tender, damaged
or scarred. Patients may self-administer Dupixent ® after
appropriate training in preparation and administration.
l PRESCRIBING AND DISPENSING INFORMATION
Manufacturer advises to record the brand name and batch
number after each administration.
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C); pre-filled syringes may be kept at
room temperature (max. 25°C) for max. 14 days.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Dupilumab for treating moderate to severe atopic dermatitis
Dupilumab (Dupixent ®) is recommended as an option for
treating moderate to severe atopic dermatitis in adults,
. the disease has not responded to at least 1 other
systemic therapy, such as ciclosporin, methotrexate,
azathioprine, and mycophenolate mofetil, or these are
contra-indicated or not tolerated, and
. the manufacturer provides dupilumab according to the
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
www.nice.org.uk/guidance/ta534
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (September
2018) that dupilumab (Dupixent ®) is accepted for restricted
inadequate response to existing systemic
immunosuppressants such as ciclosporin, or in whom such
treatment is considered unsuitable. This advice is
contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Dupilumab 150 mg per 1 ml Dupixent 300mg/2ml solution for
injection pre-filled syringes | 2 pre-filled disposable injection P £1,264.89
l DRUG ACTION Guselkumab is a recombinant human
Moderate-to-severe plaque psoriasis (specialist use only)
▶ Adult: Initially 100 mg, then 100 mg after 4 weeks, then
maintenance 100 mg every 8 weeks, consider
discontinuation if no response after 16 weeks
l CONTRA-INDICATIONS Clinically significant active
patients with a past history of latent or active tuberculosis
in whom an adequate course of treatment cannot be
Manufacturer advises consider completion of
appropriate immunisations according to current
guidelines before initiating treatment (consult product
literature for appropriate interval between vaccination and
administration of guselkumab).
l INTERACTIONS → Appendix 1: monoclonal antibodies
▶ Common or very common Arthralgia . diarrhoea . headache . increased risk of infection . urticaria
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception in women of childbearing potential
during treatment and for at least 12 weeks after treatment.
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid during
treatment and for up to 12 weeks after discontinuing
treatment—no information available.
l PRE-TREATMENT SCREENING Manufacturer advises that
patients should be evaluated for tuberculosis infection
l MONITORING REQUIREMENTS Manufacturer advises
monitor for signs and symptoms of active tuberculosis
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
to avoid injecting into areas of the skin that show
psoriasis. Patients may self-administer Tremfya ®, after
appropriate training in subcutaneous injection technique.
l PRESCRIBING AND DISPENSING INFORMATION
Manufacturer advises to record the brand name and batch
number after each administration.
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C) and protect from light.
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be advised to seek medical
attention if signs or symptoms of infection occur (monitor
closely and suspend treatment if infection is clinically
significant or unresponsive to treatment).
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Guselkumab for treating moderate to severe plaque psoriasis
Guselkumab is recommended as an option for treating
plaque psoriasis in adults, only if:
. the disease is severe, as defined by a total Psoriasis Area
and Severity Index (PASI) of 10 or more and a
1258 Inflammatory skin conditions BNF 78
Dermatology Life Quality Index (DLQI) of more than 10,
. the disease has not responded to other systemic
therapies, including ciclosporin, methotrexate and
PUVA (psoralen and long-wave ultraviolet A radiation),
or these options are contra-indicated or not tolerated,
. the manufacturer provides the drug according to the
Stop guselkumab treatment at 16 weeks if the psoriasis has
not responded adequately. An adequate response is
. a 75% reduction in the PASI score (PASI 75) from when
. a 50% reduction in the PASI score (PASI 50) and a 5-
point reduction in DLQI from when treatment started.
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
www.nice.org.uk/guidance/ta521
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (June 2018)
that guselkumab (Tremfya ®) is accepted for restricted use
within NHS Scotland for the treatment of moderate to
severe plaque psoriasis in adults who have failed to
respond to conventional systemic therapies (including
ciclosporin, methotrexate and phototherapy), are
intolerant to, or have a contra-indication to these
treatments. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Tremfya (Janssen-Cilag Ltd) A
Guselkumab 100 mg per 1 ml Tremfya 100mg/1ml solution for
injection pre-filled pens | 1 pre-filled disposable injection P £2,250.00
l DRUG ACTION Ixekizumab is a human monoclonal
antibody that binds to interleukin-17A and inhibits the
release of pro-inflammatory cytokines and chemokines.
Moderate-to-severe plaque psoriasis (under expert
supervision)| Psoriatic arthritis with concomitant
moderate-to-severe plaque psoriasis (under expert
▶ Adult: Initially 160 mg for 1 dose, followed by 80 mg
after 2 weeks, then 80 mg every 2 weeks for 5 further
doses (at weeks 4, 6, 8, 10 and 12), then maintenance
80 mg every 4 weeks, consider discontinuation of
treatment if no response after 16–20 weeks
Psoriatic arthritis (under expert supervision)
▶ Adult: Initially 160 mg for 1 dose, then maintenance
80 mg every 4 weeks, consider discontinuation of
treatment if no response after 16–20 weeks
l CONTRA-INDICATIONS Active infections (including active
l CAUTIONS Chronic infection—monitor carefully and
discontinue if serious, unresponsive infection develops . Crohn’s disease . ulcerative colitis
▶ Severe hypersensitivity reactions Severe hypersensitivity
reactions have been reported—discontinue treatment
immediately if symptoms occur.
▶ Latent tuberculosis Manufacturer advises that patients with
latent tuberculosis should complete anti-tuberculosis
therapy before starting ixekizumab.
▶ Inflammatory bowel disease Manufacturer advises to monitor
l INTERACTIONS → Appendix 1: monoclonal antibodies
▶ Common or very common Increased risk of infection . nausea . oropharyngeal pain
▶ Uncommon Conjunctivitis . neutropenia . skin reactions . thrombocytopenia
l CONCEPTION AND CONTRACEPTION Manufacturer advises
effective contraception during treatment and for at least
10 weeks after treatment in women of childbearing
l PREGNANCY Manufacturer advises avoid—limited
l BREAST FEEDING Manufacturer advises avoid—present in
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
to avoid injecting into areas of the skin that show
psoriasis; injection sites may be alternated. Patients may
self-administer Taltz ®, after appropriate training in
subcutaneous injection technique.
l HANDLING AND STORAGE Manufacturer advises store in a
Self-administration If appropriate, patients and their carers
should be given training in subcutaneous injection
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Ixekizumab for treating moderate to severe plaque psoriasis
Ixekizumab (Taltz ®) is recommended as an option for
treating plaque psoriasis only if:
. the disease is severe, defined by a total Psoriasis Area
and Severity Index (PASI) of 10 or more and a
Dermatology Life Quality Index (DLQI) of 10 or more;
. the disease has not responded to standard systemic
therapies (e.g. ciclosporin, methotrexate and PUVA) or
these treatments are contra-indicated or not tolerated,
. the manufacturer provides ixekizumab with the discount
agreed in the patient access scheme
Ixekizumab should be discontinued if there is an
inadequate response at 12 weeks.
Patients currently receiving ixekizumab, whose disease
does not meet the above criteria, should have the option to
continue treatment until they and their clinician consider
www.nice.org.uk/guidance/ta442
▶ Ixekizumab for treating active psoriatic arthritis after
inadequate response to DMARDs (August 2018) NICE TA537
Ixekizumab (Taltz ®) alone, or with methotrexate, is
recommended as an option for treating active psoriatic
. it is used as described in the NICE technology appraisal
guidance on etanercept, infliximab and adalimumab for
BNF 78 Eczema and psoriasis 1259
the treatment of psoriatic arthritis (TA199
recommendations 1.1 and 1.2), or
. the person has had a tumour necrosis factor (TNF)-alpha
inhibitor but their disease has not responded within the
first 12 weeks or has stopped responding after the first
. TNF-alpha inhibitors are contra-indicated but would
otherwise be considered (as described in the NICE
technology appraisal guidance on etanercept, infliximab
and adalimumab for the treatment of psoriatic arthritis).
Ixekizumab is only recommended if the manufacturer
provides it according to the commercial arrangement.
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
www.nice.org.uk/guidance/ta537
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2017)
that ixekizumab (Taltz ®) is accepted for restricted use
respond to standard systemic therapies (including
ciclosporin, methotrexate and phototherapy), are
intolerant to, or have a contra-indication to these
treatments. This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland,
or a list price that is equivalent or lower.
The Scottish Medicines Consortium has advised (October
2018) that ixekizumab (Taltz ®) is accepted for restricted
use within NHS Scotland, alone or in combination with
methotrexate, for the treatment of active psoriatic arthritis
in adults whose disease has not responded adequately to at
least two conventional disease-modifying anti-rheumatic
drugs given either alone or in combination, and who have
had an inadequate response to a tumour necrosis factor
This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Polysorbates
▶ Taltz (Eli Lilly and Company Ltd) A
Ixekizumab 80 mg per 1 ml Taltz 80mg/1ml solution for injection
pre-filled syringes | 1 pre-filled disposable injection P £1,125.00
Taltz 80mg/1ml solution for injection pre-filled pen | 1 pre-filled
disposable injection P £1,125.00 (Hospital only)
l DRUG ACTION Tildrakizumab is a recombinant human
Moderate-to-severe plaque psoriasis (under expert
▶ Adult: Initially 100 mg, then 100 mg after 4 weeks, then
maintenance 100 mg every 12 weeks, consider
discontinuation if no response after 28 weeks, in
patients with a high disease burden, or with a body
weight 90kg, a dose of 200 mg may provide greater
l CONTRA-INDICATIONS Clinically significant active
l CAUTIONS Chronic infection . history of recurrent
infection .recent serious infection
patients with a history of tuberculosis, in whom an
adequate course of treatment cannot be confirmed.
Manufacturer advises consider completion of
immunisations according to current guidelines before
initiating treatment (consult product literature for
appropriate interval between vaccination and
administration of tildrakizumab).
l INTERACTIONS → Appendix 1: monoclonal antibodies
▶ Common or very common Back pain . diarrhoea . headache . increased risk of infection . nausea
l CONCEPTION AND CONTRACEPTION Manufacturer advises
that women of childbearing potential should use effective
contraception during treatment and for at least 17 weeks
l PREGNANCY Manufacturer advises avoid—limited
l BREAST FEEDING Manufacturer advises avoid—limited
l PRE-TREATMENT SCREENING Manufacturer advises
patients should be evaluated for tuberculosis infection
l MONITORING REQUIREMENTS Manufacturer advises
monitor for signs and symptoms of active tuberculosis
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
to take the syringe out of the refrigerator at least
30 minutes before administration, and to avoid injecting
into areas of the skin that are affected by psoriasis or are
tender, bruised, red, hard, thick, or scaly. Patients may
self-administer Ilumetri ®, after appropriate training in
subcutaneous injection technique.
l PRESCRIBING AND DISPENSING INFORMATION
Tildrakizumab is a biological medicine. Biological
medicines must be prescribed and dispensed by brand
name, see Biological medicines and Biosimilar medicines,
under Guidance on prescribing p. 1; manufacturer advises
to record the brand name and batch number after each
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C) and protect from light—consult
product literature for further information regarding
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be advised to seek medical
advice if signs or symptoms of infection occur.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Tildrakizumab for treating moderate to severe plaque
psoriasis (April 2019) NICE TA575
Tildrakizumab (Ilumetri ®) is recommended as an option
for treating plaque psoriasis in adults, only if:
. the disease is severe, as defined by a total Psoriasis Area
and Severity Index (PASI) of 10 or more and a
Dermatology Life Quality Index (DLQI) of more than 10,
. the disease has not responded to other systemic
treatments, including ciclosporin, methotrexate and
phototherapy, or these options are contra-indicated or
. the manufacturer provides the drug according to the
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