New medicines
Orencia
Composition: Abatacept.
Presentation: Powder for concentrate for solution for infusion.
Class: Immunosuppressant.
Indications: In combination with methotrexate for the treatment of moderate
to severe active rheumatoid arthritis in adult patients who have had
an insufficient response or intolerance to other disease-modifying anti-rheumatic
drugs including at least one tumour necrosis factor inhibitor.
Dosage: For patients weighing under 60kg, 500mg (two vials). For patients
weighing 60kg to 100kg, 750mg (three vials). For patients weighing over
100kg, 1,000mg (four vials). The dose should be administered as a
30-minute intravenous infusion. Orencia should be given two and four
weeks after the first infusion, then every four weeks. Each vial of Orencia
must be reconstituted with 10ml of water for injections, using a silicone-free
syringe. The reconstituted solution must then be diluted to 100ml with
sodium chloride 0.9 per cent solution for injection, before administration
by intravenous infusion.
Contraindications: Severe and uncontrolled infections
(such as sepsis and opportunistic infections).
Precautions: Not recommended for children.
Side effects: Very common (>1/10) headache. Common (>1/100, <1,10)
increased blood pressure, abnormal liver function test, cough, abdominal
pain, diarrhoea, dizziness, nausea, dyspepsia, rash, lower respiratory
tract infection, urinary tract infection, herpes simplex, upper respiratory
tract infection, rhinitis, hypertension, flushing, fatigue, asthenia.
Legal category: POM.
Net price: 1 x 250mg vial, £252.
Contact details: Bristol-Myers Squibb, Uxbridge Business
Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH
(tel 01895 523000).
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