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See related Fabrazyme powd for inj information |
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Manufacturer |
Genzyme |
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Distributor |
Hong Kong: DKSH |
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Contents |
Agalsidase β |
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Indications |
Fabry disease. Reduces globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney & certain other cell types. |
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Dosage |
1 mg/kg body wt 2 wkly as an IV infusion. Infusion rate: Initially not >0.25 mg/min (15 mg/hr). When patient tolerance is established, rate may be increased in 0.05-0.08 mg/min increments (3-5 mg/hr). Patient ≥30 kg Duration not <1.5 hr, <30 kg Max infusion rate: 0.25 mg/min (15 mg/hr). Rechallenge 0.5 mg/kg over 0.01 mg/min. When patient tolerance is established, dose may be increased to 1 mg/kg, slowly titrating infusion rate. Max infusion rate: 0.25 mg/min as tolerated. |
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Special Precautions |
Potential severe infusion reactions. Pre-treatment w/ antipyretics prior to infusion is needed. Closely monitor compromised cardiac function. Pregnancy & lactation. Childn <8 yr. |
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Adverse Drug Reactions |
Infusion reactions eg chills, pyrexia, dyspnea, nausea, flushing, headache, vomiting, paresthesia, fatigue, pruritus, pain in extremity, HTN, chest pain, throat tightness, abdominal pain, dizziness, tachycardia, nasal congestion, diarrhea, peripheral edema, myalgia, back pain, pallor, bradycardia, urticaria, hypotension, face oedema, rash, somnolence. Stroke, pain, ataxia, bradycardia, cardiac arrhythmia, cardiac arrest, decreased cardiac output, vertigo, hypoacousia, nephrotic syndrome.
View ADR Monitoring Form |
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Pregnancy Category (US FDA) |
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters). |
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ATC Classification |
A16AB04 - agalsidase beta ; Belongs to the class of enzymes. Used in treatment of alimentary tract and metabolism problems. |
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Presentation/Packing |
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Form |
Packing |
Photo |
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Fabrazyme powder for injection |
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Fabrazyme 5 mg x 5 mL x 1's |
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Fabrazyme 35 mg x 20 mL x 1's |
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Manufacturer: |
Genzyme |
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Distributor: |
Hong Kong: DKSH
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