Abatacept International Brand (Medicinal
Forms)
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INDICATIONS AND DOSE:
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Severe plaque psoriasis either refractory to at least 2 standard systemic
treatments or photochemotherapy, or when standard treatments cannot be used
because of intolerance or contra-indications
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 80 mg, then 40 mg
every 2 weeks, to be started 1 week after initial dose, discontinue treatment if
no response within 16 weeks Moderate-to-severe active rheumatoid arthritis (in combination
with methotrexate or alone if methotrexate inappropriate) when response to
other disease modifying drugs (including methotrexate) has been inadequate |
Severe, active, and progressive rheumatoid arthritis (in combination with
methotrexate or alone if methotrexate inappropriate) not previously treated
with methotrexate
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: 40 mg every 2 weeks, then
increased if necessary
to 40 mg once weekly, dose to be increased only in patients receiving
adalimumab alone, review treatment if no response within 12 weeks Active and
progressive psoriatic arthritis that has not responded adequately to other
disease-modifying antirheumatic drugs | Severe active ankylosing spondylitis
that has not responded adequately to other disease-modifying antirheumatic
drugs | Severe axial spondyloarthritis without radiographic evidence of ankylosing
spondylitis but with objective signs of inflammation, in patients who have had
an inadequate response to, or are intolerant of, NSAIDs
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: 40 mg every 2 weeks, discontinue
treatment if no response within 12 weeks
Severe active Crohn’s disease
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 80 mg, then 40 mg
after 2 weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg
once weekly, maximum 40 mg administered at a single site, review treatment if
no response within 12 weeks of initial dose Severe active Crohn’s disease
(accelerated regimen)
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 160 mg, dose can
alternatively be given as divided injections over 2 days, then 80 mg after 2
weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once
weekly, maximum 40 mg administered at a single site, review treatment if no response
within 12 weeks of initial dose Severe active ulcerative colitis
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 160 mg, dose can
alternatively be given as divided injections over 2 days, then 80 mg after 2
weeks; maintenance 40 mg every 2 weeks, increased if necessary to 40 mg once
weekly, maximum 40mg administered at a single site, review treatment if no response
within 8 weeks of initial dose Active moderate to severe hidradenitis
suppurativa (acneinversa) in patients with an inadequate response to conventional
systemic therapy
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 160 mg, given as
either four 40 mg injections in one day or as two 40 mg injections per day for
2 consecutive days, followed by 80 mg after 2 weeks, given as two 40 mg
injections in one day, then 40 mg after 2 weeks; maintenance 40 mg once weekly,
review
treatment if no response within 12 weeks; if treatment interrupted—consult
product literature Uveitis (in combination with corticosteroids or alone if corticosteroids
inappropriate), with or without other disease-modifying drugs (initiated under
specialist
supervision)
▶ BY SUBCUTANEOUS INJECTION
▶ Adult: Initially 80 mg, given as two 40
mg injections in one day, then 40 mg after 1 week; maintenance 40 mg every 2
weeks
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CONTRA-INDICATIONS
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Moderate or severe heart failure. severe
infection
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CAUTIONS
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Demyelinating disorders (risk of exacerbation). development of
malignancy. do not initiate until active infections are controlled (discontinue
if new serious infection develops). hepatitis B virus—monitor for active infection.
history of malignancy. mild heart failure (discontinue if symptoms develop or
worsen). predisposition to infection
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CAUTIONS, FURTHER INFORMATION
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Tuberculosis Active tuberculosis should be treated with standard
treatment for at least 2 months before starting adalimumab. Patients who have
previously received adequate treatment for tuberculosis can start adalimumab 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 adalimumab. In patients at high
risk of tuberculosis who cannot be assessed by tuberculin skin test,
chemoprophylaxis can be given concurrently with adalimumab.
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INTERACTIONS
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Appendix 1: monoclonal antibodies
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SIDE-EFFECTS
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Common or
very common Anxiety. benign tumours. chest pain. cough. dehydration.
dermatitis. dizziness. dyspepsia. dyspnoea. electrolyte disturbances. Eye disorders.
flushing. gastrointestinal haemorrhage. haematuria. hyperlipidaemia.
hypertension. hyperuricaemia. impaired healing. mood changes. musculoskeletal
pain . oedema . onycholysis. paraesthesia
. rash .
renal impairment. skin cancer. sleep disturbances. tachycardia. vomiting
▶ Uncommon Aortic aneurysm . arrhythmias . cholecystitis . cholelithiasis .
dysphagia . erectile dysfunction . hearing loss . hepatic steatosis .
interstitial lung disease . leukaemia . lymphoma . malignancy . neuropathy .
nocturia . pancreatitis . pneumonitis . rhabdomyolysis . solid tumours .
tinnitus . tremor . vascular occlusion
▶ Rare Autoimmune hepatitis . demyelinating disorders . myocardial infarction
▶ Frequency not known Abdominal pain . anaemia . antibody formation .
aplastic anaemia . blood disorders . cutaneous vasculitis . depression . fever
. headache . hypersensitivity reactions . injection-site reactions . leucopenia
. lupus erythematosus-like syndrome . nausea . new onset psoriasis .
pancytopenia . pleural effusion . pruritus . pulmonary embolism . sarcoidosis .
Stevens-Johnson syndrome . thrombocytopenia . worsening heart failure . worsening
of symptoms of dermatomyositis . worsening
psoriasis
An alert card should be provided. When used to treat hidradenitis suppurativa,
patients and their carers should be advised to use a daily topical antiseptic
wash on lesions during treatment with adalimumab. Tuberculosis patients and
their carers should be advised to seek medical attention if symptoms suggestive
of tuberculosis (e.g. persistent cough, weight loss, or, and fever) develop. Blood
disorders Patients and their carers should be advised to seek medical attention
if symptoms suggestive of blood disorders (such as fever, sore throat,
bruising, or bleeding) develop.
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International Brands (Medicinal Forms)
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Sr.
#
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Brand Name
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Dosage Form
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Pack Size
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Price
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Manufacturer
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1.
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Humira 50 mg per 1 ml
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Humira
40mg/0.8ml solution for
injection
pre-filled syringes
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2
pre-filled disposable injection
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£704.28
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AbbVie
Ltd
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2.
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Adalimumab
100 mg per 1 ml
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40mg/0.4ml
solution for
injection
pre-filled pen
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2
pre-filled disposable injection
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£704.28
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AbbVie
Ltd
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Reference:
BNF
74, Page No. 1007