Abatacept International Brand (Medicinal Forms)

  
INDICATIONS AND DOSE:

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

CONTRA-INDICATIONS

Moderate or severe heart failure. severe infection

CAUTIONS

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

CAUTIONS, FURTHER INFORMATION

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.

INTERACTIONS

Appendix 1: monoclonal antibodies
           
SIDE-EFFECTS

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.

International Brands (Medicinal Forms)

Sr. #
Brand Name
Dosage Form
Pack Size
Price
Manufacturer
1.
Humira  50 mg per 1 ml
Humira 40mg/0.8ml solution for
injection pre-filled syringes
2 pre-filled disposable injection
£704.28
AbbVie Ltd
2.
Adalimumab 100 mg per 1 ml
40mg/0.4ml solution for
injection pre-filled pen
2 pre-filled disposable injection
£704.28
AbbVie Ltd


Reference:
BNF 74, Page No. 1007

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