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Idursulfase for intravenous infusion
ELAPRASE™
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FDA Approval: |
July 2006 |
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Indication: |
Hunter syndrome (Mucopolysaccaridosis II) |
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Pharmacology: |
Recombinant human iduronate-2-sulfatase |
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Usual Dose: |
0.5 mg/kg by IV infusion once a week |
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Contraindications: |
none |
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Warnings: |
Severe and life-threatening hypersensitivity reactions have
occurred during infusion, including anaphylactoid reactions,
respiratory distress, hypoxia, hypotension, angioedema, seizures,
cyanosis.
Patients with acute respiratory disease or compromised
respiratory function may have a greater risk of developing
life-threatening complications. Deferring infusion should be
considered in patients with acute respiratory or febrile illnesses.
Caution recommended during lactation Safety and effectiveness not established in patients
younger than 5 years |
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Pregnancy Category: |
C |
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Side Effects: |
Infusion reactions, hypoxia, cardiac arrhythmia, pulmonary embolism,
cyanosis, respiratory failure, infection, arthralgia Pyrexia,
headache, arthralgia, limb pain, pruritus, hypertension, malaise,
visual disturbances, wheezing, abscess, musculoskeletal dysfunction,
chest wall pain, urticaria, injury, anxiety, irritability, atrial
abnormality, dyspepsia, infusion site edema, skin disorder, pruritic
rash, development of anti-idursulfase antibodies |
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Drug Interactions: |
unknown |
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