New medicines
Tysabri
Composition: Natalizumab.
Presentation: Concentrate for solution for infusion.
Class: Selective immunosuppressive agent.
Indications: Treatment of highly active relapsing remitting multiple
sclerosis (as a single disease modifying therapy) for patients with high
disease activity (despite treatment with a beta-interferon) and for patients
with rapidly evolving severe relapsing remitting multiple sclerosis.
Dosage: 300 mg by intravenous infusion once every four weeks.
Contraindications: Children, adolescents and patients with progressive
multifocal leukoencephalopathy, increased risk of opportunistic infections
(including immunocompromised patients) and known active malignancies
(except for patients with cutaneous basal cell carcinoma). Tysabri is
also contraindicated for treatment in combination with beta-interferons
or glatiramer acetate.
Precautions: Tysabri is not recommended for the treatment of patients
aged over 65 years. Before initiation of treatment with Tysabri, a recent
magnetic resonance image should be available. Patients should also be
advised to inform their partners or carers about their treatment, since
they may notice symptoms of which the patient is not aware and which
are suggestive of progressive multifocal leukoencephalopathy.
Side effects: Common (> 1/100, < 1/10) urinary tract infection,
nasopharyngitis, urticaria, headache, dizziness, vomiting, nausea, arthralgia,
rigors, pyrexia, fatigue.
Legal category: POM.
Net price: £1,130.
Contact details: Biogen Idec,
5 Roxborough Way, Foundation Park, Maidenhead, Berkshire SL6 3UD. Telephone
08000 286339.
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