l NATIONAL FUNDING/ACCESS DECISIONS
▶ Belimumab for treating active autoantibody-positive systemic
lupus erythematosus (June 2016) NICE TA397
Belimumab (Benlysta ®) is recommended as an add-on
. there is evidence for serological disease activity (defined
as positive anti-double-stranded DNA and low
complement) and a Safety of Estrogen in Lupus National
Assessment – Systemic Lupus Erythematosus Disease
Activity Index (SELENA-SLEDAI) score of greater than or
equal to 10 despite standard therapy;
. treatment with belimumab is continued after 24 weeks
only if the SELENA-SLEDAI score has improved by 4
. the manufacturer provides belimumab with the discount
agreed in the patient access scheme; and
. under the conditions specified in the NICE managed
access agreement documentation.
Patients whose treatment was started before this guidance
was published should continue treatment, without change
to their funding arrangements, until they and their NHS
clinician consider it appropriate to stop.
www.nice.org.uk/guidance/ta397
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2017)
that belimumab (Benlysta ®) is accepted for restricted use
within NHS Scotland as adjunctive therapy in patients with
active, autoantibody-positive systemic lupus
erythematosus with a high degree of disease activity
despite standard therapy, and who have evidence of
serological disease activity and a Safety of Estrogens in
Lupus Erythematosus National Assessment-Systemic
upon the continuing availability of the Patient Access
Scheme in NHS Scotland or a list price that is equivalent or
BNF 78 Immune system disorders and transplantation 845
Immune system and malignant disease
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Benlysta (GlaxoSmithKline UK Ltd) A
Belimumab 120 mg Benlysta 120mg powder for concentrate for
solution for infusion vials | 1 vial P £121.50 (Hospital only)
Belimumab 400 mg Benlysta 400mg powder for concentrate for
solution for infusion vials | 1 vial P £405.00 (Hospital only)
IMMUNOSUPPRESSANTS › PURINE SYNTHESIS
Mycophenolate mofetil 09-Mar-2018
Prophylaxis of acute rejection in renal transplantation (in
combination with a corticosteroid and ciclosporin)
▶ Adult: 1 g twice daily, to be started within 72 hours of
▶ Adult: 1 g twice daily for maximum 14 days, then
transfer to oral therapy, to be started within 24 hours
Prophylaxis of acute rejection in cardiac transplantation
(in combination with ciclosporin and corticosteroids)
▶ Adult: 1.5 g twice daily, to be started within 5 days of
Prophylaxis of acute rejection in hepatic transplantation
(in combination with ciclosporin and corticosteroids)
▶ INITIALLY BY INTRAVENOUS INFUSION
▶ Adult: 1 g twice daily for 4 days, up to a maximum of
14 days, to be started within 24 hours of
transplantation, then (by mouth) 1.5 g twice daily, the
dose route should be changed as soon as is tolerated
Renal transplantation (specialist use only)
▶ Adult: 720 mg twice daily, to be started within 72 hours
DOSE EQUIVALENCE AND CONVERSION
▶ For Ceptava ®: Mycophenolic acid 720 mg is
approximately equivalent to mycophenolate mofetil 1 g
but avoid unnecessary switching because of
Renal transplantation (specialist use only)
▶ Adult: 720 mg twice daily, to be started within 72 hours
DOSE EQUIVALENCE AND CONVERSION
▶ For Myfortic ®: Mycophenolic acid 720 mg is
approximately equivalent to mycophenolate mofetil 1 g
but avoid unnecessary switching because of
MHRA/CHM ADVICE: MYCOPHENOLATE MOFETIL, MYCOPHENOLIC
ACID: UPDATED CONTRACEPTION ADVICE FOR MALE PATIENTS
Available clinical evidence does not indicate an
increased risk of malformations or miscarriage in
pregnancies where the father was taking mycophenolate
medicines, however mycophenolate mofetil and
mycophenolic acid are genotoxic and a risk cannot be
fully excluded; for further information, see Conception
and contraception and Patient and carer advice.
l CAUTIONS Active serious gastro-intestinal disease (risk of
haemorrhage, ulceration and perforation). children
(higher incidence of side-effects may call for temporary
haemorrhage and pulmonary oedema). increased
susceptibility to skin cancer (avoid exposure to strong
sunlight).risk of hypogammaglobulinaemia or
bronchiectasis when used in combination with other
▶ Hypogammaglobulinaemia or bronchiectasis Measure serum
immunoglobulin levels if recurrent infections develop, and
consider bronchiectasis or pulmonary fibrosis if persistent
respiratory symptoms such as cough and dyspnoea
l INTERACTIONS → Appendix 1: mycophenolate
disorders . pain . pancreatitis . paraesthesia .renal
impairment.respiratory disorders . seizure . sepsis . skin
reactions .tachycardia .thinking abnormal . thrombocytopenia .tremor. vomiting . weight decreased
▶ With intravenous use Hepatitis . muscle tone increased
SIDE-EFFECTS, FURTHER INFORMATION Cases of pure red
cell aplasia have been reported with mycophenolate
mofetil; dose reduction or discontinuation should be
considered under specialist supervision.
l CONCEPTION AND CONTRACEPTION
Pregnancy prevention The MHRA advises to exclude
pregnancy in females of child-bearing potential before
treatment—2 pregnancy tests 8–10 days apart are
recommended. Women should use at least 1 method of
effective contraception before and during treatment, and
for 6 weeks after discontinuation—2 methods of effective
contraception are preferred. Male patients or their female
partner should use effective contraception during
treatment and for 90 days after discontinuation.
l PREGNANCY Avoid unless no suitable alternative—
congenital malformations and spontaneous abortions
l BREAST FEEDING Manufacturer advises avoid—present in
l RENAL IMPAIRMENT No data available in cardiac or hepatic
transplant patients with renal impairment.
l MONITORING REQUIREMENTS Monitor full blood count
every week for 4 weeks then twice a month for 2 months
846 Immune system disorders and transplantation BNF 78
Immune system and malignant disease
then every month in the first year (consider interrupting
treatment if neutropenia develops).
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intravenous infusion (CellCept ®),
give intermittently in Glucose 5%; reconstitute each 500–
mg vial with 14 mL glucose 5% and dilute the contents of
2 vials in 140 mL infusion fluid; give over 2 hours.
Pregnancy prevention advice The MHRA advises that
prescribers should ensure that female patients understand
the need to comply with the pregnancy prevention advice,
and they should be informed to seek immediate medical
attention if there is a possibility of pregnancy; male
patients planning to conceive children should be informed
of the implications of both immunosuppression and the
effect of the prescribed medications on the pregnancy.
Bone marrow suppression Patients should be warned to
report immediately any signs or symptoms of bone marrow
suppression e.g. infection or inexplicable bruising or
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Immunosuppressive therapy for kidney transplant in adults
Mycophenolate mofetil, when used as part of an
immunosuppressive regimen, is recommended as an initial
option to prevent organ rejection in adults 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
www.nice.org.uk/guidance/TA481
▶ Immunosuppressive therapy for kidney transplant in adults
Mycophenolate sodium (Ceptava ®, Myfortic ®) is not
recommended as an initial treatment to prevent organ
rejection in adults 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
www.nice.org.uk/guidance/TA481
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 25
▶ Mycophenolate mofetil (Non-proprietary)
Mycophenolic acid (as Mycophenolate sodium)
180 mg Mycophenolic acid 180mg gastro-resistant tablets | 120 tablet P £101.07 DT = £96.72
Mycophenolic acid (as Mycophenolate sodium)
360 mg Mycophenolic acid 360mg gastro-resistant tablets | 120 tablet P £202.13 DT = £193.43
Mycophenolic acid (as Mycophenolate sodium) 180 mg Ceptava
180mg gastro-resistant tablets | 120 tablet P £77.38 DT = £96.72
Mycophenolic acid (as Mycophenolate sodium) 360 mg Ceptava
360mg gastro-resistant tablets | 120 tablet P £154.75 DT =
▶ Myfortic (Novartis Pharmaceuticals UK Ltd)
Mycophenolic acid (as Mycophenolate sodium) 180 mg Myfortic
180mg gastro-resistant tablets | 120 tablet P £96.72 DT = £96.72
Mycophenolic acid (as Mycophenolate sodium) 360 mg Myfortic
360mg gastro-resistant tablets | 120 tablet P £193.43 DT =
▶ Mycophenolate mofetil (Non-proprietary)
Mycophenolate mofetil 500 mg Mycophenolate mofetil 500mg
tablets | 50 tablet P £42.50 DT = £5.83
▶ CellCept (Roche Products Ltd)
Mycophenolate mofetil 500 mg CellCept 500mg tablets |
Mycophenolate mofetil 500 mg Myfenax 500mg tablets | 50 tablet P £78.15 DT = £5.83
EXCIPIENTS: May contain Aspartame
▶ CellCept (Roche Products Ltd)
Mycophenolate mofetil 200 mg per 1 ml CellCept 1g/5ml oral
suspension sugar-free | 175 ml P £115.16 DT = £115.16
Powder for solution for infusion
▶ Mycophenolate mofetil (Non-proprietary)
Mycophenolate mofetil (as Mycophenolate mofetil
hydrochloride) 500 mg Mycophenolate mofetil 500mg powder for
concentrate for solution for infusion vials | 4 vial P £34.67
▶ CellCept (Roche Products Ltd)
Mycophenolate mofetil (as Mycophenolate mofetil
hydrochloride) 500 mg CellCept 500mg powder for solution for
infusion vials | 4 vial P £36.49
▶ Mycophenolate mofetil (Non-proprietary)
Mycophenolate mofetil 250 mg Mycophenolate mofetil 250mg
capsules | 100 capsule P £82.26 DT = £82.26
▶ CellCept (Roche Products Ltd)
Mycophenolate mofetil 250 mg CellCept 250mg capsules | 100 capsule P £82.26 DT = £82.26
Mycophenolate mofetil 250 mg Myfenax 250mg capsules | 100 capsule P £78.15 DT = £82.26
IMMUNOSUPPRESSANTS › T-CELL ACTIVATION
Prophylaxis of graft rejection in adults undergoing renal
transplantation who are seropositive for the EpsteinBarr virus
▶ Adult: (consult product literature)
l CAUTIONS Increased risk of acute graft rejection—with
tapering of corticosteroid, particularly in patients with
high immunologic risk . increased risk of infection . latent
and active tuberculosis .risk factors for post-transplant
l INTERACTIONS → Appendix 1: belatacept
complaints . muscle weakness . nausea . neoplasms . nerve
BNF 78 Immune system disorders and transplantation 847
Immune system and malignant disease
disorders . neutropenia . oral disorders . oropharyngeal
complaints . osteoarthritis . pain . paraesthesia . peripheral
disorders . ventricular hypertrophy . vertigo . vesicoureteric
reflux . vision disorders . vomiting . weight changes
▶ Uncommon Acute coronary syndrome . adrenal
insufficiency . agranulocytosis . alkalosis . anxiety . aortic
haematoma . procedural complications . progressive
multifocal leukoencephalopathy (PML). pulmonary
SIDE-EFFECTS, FURTHER INFORMATION Side effects are
reported when used in combination with basiliximab,
mycophenolate mofetil and corticosteroids.
l CONCEPTION AND CONTRACEPTION Adequate
contraception must be used during treatment and for up to
l PREGNANCY Use only if essential.
l BREAST FEEDING Avoid—no information available.
l PRE-TREATMENT SCREENING Patients should be evaluated
for latent and active tuberculosis before starting
l MONITORING REQUIREMENTS Patients should be
monitored for signs and symptoms of tuberculosis during
l PATIENT AND CARER ADVICE Patients should be advised to
avoid excessive exposure to UV light including sunlight.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Immunosuppressive therapy for kidney transplant in adults
Belatacept is not recommended as an initial treatment to
prevent organ rejection in adults 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.
www.nice.org.uk/guidance/TA481
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Nulojix (Bristol-Myers Squibb Pharmaceuticals Ltd)
Belatacept 250 mg Nulojix 250mg powder for concentrate for
solution for infusion vials | 1 vial P £354.52 (Hospital only) | 2 vial P £709.04 (Hospital only)
Multiple sclerosis 02-Nov-2016
Multiple sclerosis is a chronic, immune-mediated,
demyelinating inflammatory condition of the central
nervous system, which affects the brain, optic nerves and
spinal cord, and leads to progressive severe disability.
Relapsing-remitting multiple sclerosis is the most common
pattern of the disease. It is characterised by periods of
exacerbation of symptoms (relapses) followed by
unpredictable periods of stability (remission). The severity
and frequency of relapses varies greatly between patients,
but on average occur once or twice per year. This clinical
pattern often develops into secondary-progressive multiple
sclerosis, with progressive disability unrelated to relapses.
Most patients develop secondary progressive disease
Primary-progressive multiple sclerosis follows a gradual
course, with the development of symptoms that worsen over
time, without relapses and remissions.
Progressive-relapsing multiple sclerosis follows a course of
steadily worsening neurological function from onset, in
Disease activity in relapsing-remitting multiple sclerosis
Active disease is defined as at least two clinically significant
relapses occurring within the last 2 years. Highly active
disease is characterised by an unchanged/increased relapse
rate or by ongoing severe relapses compared with the
previous year, despite treatment with interferon beta p. 850.
Rapidly-evolving severe relapsing-remitting multiple sclerosis
is defined by two or more disabling relapses in 1 year, and
one or more gadolinium-enhancing lesions on brain
magnetic resonance imaging (MRI) or a significant increase
in T2 lesion load compared with a previous MRI.
There is no cure for multiple sclerosis. The overall aims of
treatment are to modify the course of the disease and
manage symptoms, in order to improve quality of life.
Treatment is aimed at reducing the frequency and duration
of relapses and at preventing or slowing disability.
Shared decision-making between the patient and their
clinicians is particularly important in the treatment of
multiple sclerosis, due to the unpredictability of the
condition and the lack of evidence of long-term benefit of
treatments.g A discussion about treatment options,
disease activity, risk, and benefit should take place to ensure
that treatment choices are right for the patient and their
circumstances. hThe choice of drug also depends on the
patient’s disability status, individual tolerance, disease
initiated as early as possible, under the supervision of a
Note: NHS England (May 2014) has provided guidance on
the use of interferon beta, glatiramer acetate p. 852,
fingolimod p. 854 and natalizumab p. 857 for the treatment
of multiple sclerosis in England, see Useful resources below.
This Clinical Commissioning Policy outlines the funding
arrangements and the criteria for initiating and
discontinuing these treatment options. See also National
funding/access decisions, under individual monographs for
teriflunomide p. 859, dimethyl fumarate p. 853 and
848 Immune system disorders and transplantation BNF 78
Immune system and malignant disease
Low levels of vitamin D are believed to be a risk factor for
developing multiple sclerosis. Patients with diagnosed
multiple sclerosis are usually given regular vitamin D after
assessment of their serum levels of vitamin D, but there is
insufficient evidence to support its use as a treatment for
multiple sclerosis.g Patients should not be offered
vitamin D solely for the purpose of treating multiple
Relapsing-remitting multiple sclerosis
g Disease-modifying drugs are the recommended
acetate may be the preferred choice for some patients, due to
their established safety profile, and the long term clinical
available as an alternative to the non-pegylated interferon
Teriflunomide and dimethyl fumarate are treatment
options for patients with active disease.g They may be
preferred due to their oral route of administration. hThere
is insufficient evidence for the use of either drug to treat
highly active or rapidly-evolving severe relapsing-remitting
g More active disease may be treated with natalizumab
or alemtuzumab. Natalizumab may be preferred due to the
complex safety profile associated with alemtuzumab.
Natalizumab is only recommended for the treatment of
rapidly-evolving severe relapsing-remitting multiple sclerosis.
Although licensed as a treatment option in all patients with
active disease, alemtuzumab may be used more frequently in
patients for whom other disease-modifying treatments have
not been effective, due to the risk of serious side effects
Fingolimod is also taken by the oral route and is the
recommended treatment for patients with highly active
disease. hThe NHS England Clinical Commissioning
Policy (see Useful resources below) advises that fingolimod is
a suitable alternative for patients receiving natalizumab who
are at high risk of developing progressive multifocal
leukoencephalopathy (defined as patients previously
exposed to the JC virus or who are receiving
immunosuppressants or who have been receiving treatment
with natalizumab for more than 2 years).
Secondary progressive multiple sclerosis
Currently, only interferon beta 1b is licensed for use in
secondary progressive multiple sclerosis. Interferon beta 1b
reduces the risk of relapse and of short-term relapse-related
disability, but does not prevent the development of
permanent physical disability or retard progression once it is
established. Therefore its role in secondary progressive
Primary progressive multiple sclerosis
Currently there are no effective disease-modifying
treatments licensed for primary progressive multiple
sclerosis. Interferon beta [unlicensed indication] has been
used, but there is limited evidence to support its use due to
the lack of a significant reduction in disability progression.
Progressive-relapsing multiple sclerosis
There are no specific treatment options for this type of
Other than episodes of neurological dysfunction, chronic
symptoms (such as fatigue, spasticity, visual problems, and
emotional lability) produce much of the disability in multiple
sclerosis.g Smoking may increase the progression of
disability in multiple sclerosis, and Smoking cessation p. 497
Suspected relapses should be referred to a specialist for
diagnosis and treatment.g Corticosteroids are
recommended for reducing inflammation and accelerating
recovery in acute relapses of relapsing-remitting multiple
sclerosis. Oral methylprednisolone p. 678 is recommended as
the first-line option. Intravenous methylprednisolone
should be considered as an alternative if oral
methylprednisolone has failed or is not tolerated or if
hospitalisation is required. h
g Regular exercise may have beneficial effects on
mobility and fatigue in patients with multiple sclerosis, and
should be encouraged. Cognitive behavioural techniques for
fatigue should also be considered in combination with
exercise. Amantadine hydrochloride p. 418 [unlicensed
indication] may be used to treat fatigue related to multiple
sclerosis. Vitamin B12 injections are not recommended as a
treatment for fatigue in patients with multiple sclerosis. h
Fampridine p. 850 is licensed for the improvement of
walking in patients with multiple sclerosis who have a
Many factors may aggravate spasticity in multiple sclerosis,
including constipation, infection, poor mobility aids,
pressure ulcers, posture and pain.g These causes should
be managed appropriately. The first-line options for
managing spasticity in multiple sclerosis are baclofen
p. 1128 or gabapentin p. 315 [unlicensed indication]. They
may be used cautiously in combination if the individual
drugs are ineffective or if side effects prevent an increase in
the dose of either drug. Tizanidine p. 1129 or dantrolene
sodium p. 1346 are second-line options; benzodiazepines
may be used as third-line therapy and may also be effective
in treating nocturnal spasms. hA cannabis extract p. 1127
containing dronabinol and cannabidiol is licensed as an
adjunct treatment for moderate-to-severe spasticity
associated with multiple sclerosis in patients who have not
responded adequately to other skeletal muscle relaxants.
g NICE do not consider it to be a cost-effective treatment
and do not recommend its use. h
g Gabapentin [unlicensed indication] is the first-line
treatment for oscillopsia; memantine hydrochloride p. 304
[unlicensed indication] is the second-line option. h
g Amitriptyline hydrochloride p. 372 [unlicensed
indication] may be used to treat emotional lability in
patients with multiple sclerosis. h
Clinical Commissioning Policy: disease modifying therapies
for patients with multiple sclerosis. NHS England. May 2014.
www.england.nhs.uk/commissioning/spec-services/npc-crg/
Multiple sclerosis in adults: management. National
Institute for Health and Care Excellence. Clinical guideline
www.nice.org.uk/guidance/cg186
Other drugs used for Multiple sclerosis Cladribine, p. 906
Immune system and malignant disease
CHOLINERGIC RECEPTOR STIMULATING DRUGS
Improvement of walking disability in multiple sclerosis
▶ Adult: 10 mg every 12 hours, discontinue treatment if
l CONTRA-INDICATIONS History of seizures (discontinue
l INTERACTIONS → Appendix 1: fampridine
▶ Common or very common Anxiety . asthenia . balance
▶ Uncommon Seizure . skin reactions .tachycardia
l PREGNANCY Avoid—toxicity in animal studies.
l BREAST FEEDING Avoid—no information available.
l RENAL IMPAIRMENT Avoid if eGFR less than
l PRESCRIBING AND DISPENSING INFORMATION Dispense in
original container (pack contains a desiccant) and discard
any tablets remaining 7 days after opening.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2018) that fampridine (Fampyra ®) is not recommended for
use within NHS Scotland for the improvement of walking
in adult patients with multiple sclerosis (MS) with walking
disability (EDSS [expanded disability status scale] 4 to 7) as
the economic case was not demonstrated.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: capsule
CAUTIONARY AND ADVISORY LABELS 23, 25
Fampridine 10 mg Fampyra 10mg modified-release tablets |
28 tablet P £181.00 | 56 tablet P £362.00
IMMUNOSTIMULANTS › INTERFERONS
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
secondary progressive multiple sclerosis with active
disease | For a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
secondary progressive multiple sclerosis with active
disease | For a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
REBIF ® PRE-FILLED PEN AND SYRINGE
For relapsing, remitting multiple sclerosis (characterised
by at least two attacks of neurological dysfunction over
the previous 2 or 3 years, followed by complete or
incomplete recovery) who are able to walk unaided | For
a single demyelinating event with an active
inflammatory process (if severe enough to require
intravenous corticosteroid and patient at high risk of
developing multiple sclerosis)
▶ Adult: (consult product literature)
l CONTRA-INDICATIONS Decompensated liver disease . severe depressive illness
CONTRA-INDICATIONS, FURTHER INFORMATION
Consult product literature for further information on
l CAUTIONS History of cardiac disorders . history of
depressive disorders (avoid in severe depression or in
those with suicidal ideation). history of seizures . history
CAUTIONS, FURTHER INFORMATION Consult product
literature for further information on cautions.
850 Immune system disorders and transplantation BNF 78
Immune system and malignant disease
l INTERACTIONS → Appendix 1: interferons
reactions . vasodilation . vomiting . weight changes
▶ Rare or very rare Cardiomyopathy . dyspnoea . haemolytic
uraemic syndrome . hyperthyroidism .thrombotic
▶ With intramuscular use Muscle complaints . musculoskeletal
stiffness . neuromuscular dysfunction .rhinorrhoea . sensation abnormal . sweat changes
▶ With subcutaneous use Anaemia .tachycardia
▶ With subcutaneous use Suicide attempt
▶ With subcutaneous use Bronchospasm . pancreatitis .thyroid
effects . pancytopenia . psychosis . suicide . syncope . systemic lupus erythematosus (SLE)
▶ With subcutaneous use Abdominal pain . abscess . capillary
leak syndrome . conjunctivitis . constipation . cough
increased . myalgia . paraesthesia . peripheral oedema . urinary disorders . visual impairment
l CONCEPTION AND CONTRACEPTION Effective
contraception required during treatment—consult product
l PREGNANCY Avoid unless potential benefit outweighs risk
l BREAST FEEDING Avoid—no information available.
l HEPATIC IMPAIRMENT Caution in severe hepatic
l RENAL IMPAIRMENT Caution in severe renal impairment.
▶ Monitor for signs of hepatic injury—hepatic failure has
▶ Patients should be monitored for clinical features of
thrombotic microangiopathy (TMA), including
thrombocytopenia, new onset hypertension, fever, central
nervous system symptoms (e.g. confusion and paresis),
and impaired renal function. Any signs of TMA should be
investigated fully and, if diagnosed, interferon beta should
be stopped immediately and treatment for TMA promptly
initiated (consult product literature for details).
▶ Patients should also be monitored for signs and symptoms
of nephrotic syndrome, including oedema, proteinuria,
and impaired renal function—monitor renal function
periodically. If nephrotic syndrome develops, treat
promptly and consider stopping interferon beta treatment.
l PRESCRIBING AND DISPENSING INFORMATION
REBIF ® CARTRIDGE Cartridges for use with RebiSmart ®
BETAFERON ® INJECTION An auto-injector device
(Betaject ® Light) is available from Bayer Schering.
EXTAVIA ® An auto-injector device (ExtaviPro ® 30G) is
supplied as part of the ExtaviPro ® 30G kit.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Beta interferons and glatiramer acetate for treating multiple
sclerosis (June 2018) NICE TA527
Interferon beta-1a (Avonex ®, Rebif ®) is recommended as
an option for treating multiple sclerosis, only if:
. the person has relapsing–remitting multiple sclerosis,
. the manufacturer provides it according to the
Interferon beta-1b (Extavia ®) is recommended as an
option for treating multiple sclerosis, only if:
. the person has relapsing–remitting multiple sclerosis
and has had 2 or more relapses within the last 2 years, or
. the person has secondary progressive multiple sclerosis
. the manufacturer provides it 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/ta527
▶ Beta interferons and glatiramer acetate for treating multiple
sclerosis (June 2018) NICE TA527
Interferon beta-1b (Betaferon ®) is not recommended
within its marketing authorisation as an option for
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/ta527
NHS England Clinical Commissioning Policy NHS England
(May 2014) has provided guidance on the use of interferon
beta p. 850 for the treatment of multiple sclerosis in
England. An NHS England Clinical Commissioning Policy
outlines the funding arrangements and the criteria for
initiating and discontinuing this treatment option, see
www.england.nhs.uk/commissioning/spec-services/npc-crg/
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Benzyl alcohol
Interferon beta-1a 12 mega u per 1 ml Avonex 30micrograms/0.5ml
(6million units) solution for injection pre-filled syringes | 4 pre-filled
disposable injection P £654.00 | 12 pre-filled disposable
Interferon beta-1a 12 mega u per 1 ml Rebif 22micrograms/0.5ml
(6million units) solution for injection pre-filled syringes | 12 pre-filled
disposable injection P £613.52
Rebif 22micrograms/0.5ml (6million units) solution for injection 1.5ml
cartridges | 4 cartridge P £613.52
Interferon beta-1a 24 mega u per 1 ml Rebif 44micrograms/0.5ml
(12million units) solution for injection pre-filled pen | 12 pre-filled
disposable injection P £813.21
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