GENZYME CORPORATION INC.
GENZYME CORPORATION INC.
Laronidase 2.9mg/ml per 5ml injection solution concentrate in 5ml single use vials,
|2.9mg/ml inj soln.||0.00||in 5ml single-use vials|
List of Related Indications:
List Of Drugs:
- Laronidase - @ -Somastatin Analogs
Indication Type Description:
Dosages/ Overdosage Etc
Pregnancy and lactation
Cardiovascular - dependent edema 9% hypotension 9% vein disorder 14%
CNS- hyperereflexia 14% paresthesia 14%
Local - injection site pain 9%
Miscellaneous- abscess 9% bilirubnemia 9% chest pain 9% corneal opacity 9%
facial edema 9% rash 9% thrombocytopenia 9%
upper respiratory tract infection 32%
Pretreatment- ensure that patients receive antipyretics and/or antihistamines prior to infusion
If an infusion reaction occurs regardless of pretreatment , decreasing the infusion rate, temporarily
stopping the infusion and/ or additional antipyretics and or antihistamines may amelorate
If severe hypersensitivity or anaphylactic reactions occur immediately discontinue infusion
of lardoniase and initiate appropriate treatment
Immunogenicity- the clinical significane of antibodies to laronidase including the potential for
product neutralization is not known.
Hypersensitivity- life threatening anaphylactic reactions have been observed in some patients
during or upto 3 hours after lardoniase infusions. Recations included respiratory failure ,
respiratory distress, stridor, tachypnea, bronchospasm, airway obstruction, hypotension,
Consider the risks and benefits of readministrering laronidase following severe
Pregnancy- use lardonidase during pregnancy only if needed
Lactation- excercise caution when laronodase is administred to a breast feeding woman
Children- not known if children younger than 5 years of age respond differently from older children.
Dosages/ Overdosage Etc:
0.58mg/kg once weekly as an intervenous infusion
Pretreatment with antipyretic is recommended and or antihistamine is recommended 60 minutes
prior to start of the infusion.
1. Inform patients that a registry for mucopolysaccharidosis I patients has been established in
order to better understand the variability and progression of mucopolysaccharodosis I disease
and to monitor and evaluate treatments.
2. Encourage patients to participate andadvice them of their participation invloves long-term
follow up .
Pregnancy and lactation:
Use lardonidase during pregnancy only if needed
Excercise caution when laronodase is administred to a breast feeding woman
Not known if children younger than 5 years of age respond differently from older children.