New medicines
Elaprase
Composition: Idursulfase.
Presentation: Concentrate for solution for infusion.
Class: Purified form of iduronate-2-sulfatase lysosomal enzyme.
Indications: Long-term treatment of patients with Hunter syndrome (mucopolysaccharidosis
II).
Dosage: 0.5mg/kg every week by intravenous infusion over three hours
(the infusion time can be gradually reduced to one hour if no infusion-associated
reactions occur).
Precautions: Patients with severe underlying airway disease should be
closely monitored throughout the infusion; limitation or monitoring of
the use of antihistamine and other sedative medicine in such patients
is recommended. Consideration should be given to delaying the infusion
for patients with acute febrile respiratory illness. Patients who develop
IgM or IgG antibodies are at a higher risk of infusion reactions and
other adverse reactions. Elaprase is not indicated for use in women of
child-bearing potential.
Side effects: Very common (>1/10) headache, hypertension, dyspepsia,
urticaria, rash, pruritus, chest pain, pyrexia, infusion site swelling.
Common (>1/100, <1/10) dizziness, tremor, increased lacrimation,
arrhythmia, cyanosis, hypotension, flushing, pulmonary embolism, bronchospasm,
cough, wheezing, tachypnoea, dyspnoea, abdominal pain, nausea, diarrhoea,
swollen tongue, face oedema, erythema, eczema, arthralgia, peripheral
oedema.
Legal category: POM.
Net price: 1 x 6mg/3ml vial, £1,985.
Contact details: Shire Pharmaceuticals Ltd, Hampshire International Business
Park, Basingstoke, Hampshire RG24 8EP (tel 01256 894430).
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