Indication:
Glaucher disease
Adverse Reaction:
Adverse reactions-
include- discomfort, pruritus, burning, swelling, or sterile abcess at the site of venipuncture
These reactions occurred in 1% of the total population
Miscellaneous- nausea,abdominal pain, vomiting. diarrhea, rash, fatigue, headache, fever,
dizziness, chills, backache, and tachycardia
Contra-Indications:
Special precautions-
Antibodies- patients with antibody to imiglucerase for injection have a higher risk of
hypersensitivity reactions. Conversely not all patients with symptoms of hypersensitivity have
a detectable IgG .It is suggested that patients be monitored periodically for IgG antibody
formation during the first year of treatment.
Pulmonary hypertension and pneumonia- Pulmonary hypertension and pneumonia are known
complications of Gaucher disease. Evaluate patients with respiratory synptoms in absence of
fever for the presence of pulmonary hypertension
Prior treatment with algucerase- caution may be advisable in administration of imiglucerase
to patients previously treated with alglucerase and who have developed antibody to alglucerase
or who exhibited symptoms of hypersensitivity to alglucerase
Hypersensitivity reactions- cautiously approach treatment with imiglucerase in patients who
exhibited symptoms of hypersensitivity to the product.
Pregnancy- do not administer imiglucerase during pregnancy when the indication and need
are clear and the potential rbenefit is judged by the healthcare provider to substantially
justify the risk.
Lactation- excercise caution when admnistering to a nursing woman.
Children-the safety and efficacy of imiglucerase have not been established in patients between
2 and 6 years of age.
Imiglucerase has been administered to patients younger than 2 years of age, however,
the safety and effectiveness in patients younger than 2 years of age have not been established
Dosages/ Overdosage Etc:
Indication-
Glaucher disease
Dosage- Imiglucerase is administred by IV infusion for 1 to 2 hours.
Individualize dose to each patient. Initial dosage range from 2.5units/kg of body weight
3 times a week to 60units/kg once every 2 weeks
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
aglucerase or imiglucerase.. Also tell your healthcare care professional
if you are allergic to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans or animals.
3. Breast-feeding-
Mothers who are taking this medicine and who wish to breast feed should discuss this
with their doctor.
4.Children-
This medicine is not expected to cause different side effects or problems
in children than it does in adults.
5.Older adults-
There is no specific information comparing use of aglucerase in the elderly
with use in other age groups
6. Other medicines-
Tell your doctor if you are using any other prescription or
non-prescription (Over-the counter) OTC medicine.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Imiglucerase catalyses the hydrolysis of glucocerebroside to glucose and ceramide
Pregnancy and lactation:
Pregnancy-
Do not administer imiglucerase during pregnancy when the indication and need
are clear and the potential rbenefit is judged by the healthcare provider to substantially
justify the risk.
Lactation-
Excercise caution when admnistering to a nursing woman.
Children-
The safety and efficacy of imiglucerase have not been established in patients between
2 and 6 years of age.
Imiglucerase has been administered to patients younger than 2 years of age, however,
the safety and effectiveness in patients younger than 2 years of age have not been established
Manufacturer Details