Drug Interaction:
Drug/Lab test interactions-
False positive pregnancy tests have been reported
Indication:
Gaucher Disease Type 1
Adverse Reaction:
Adverse reactions have occurred during or shortly after infusions-
Symptoms include- pruritus, flushing, urticaria/angioedema, . A small number have had upper
airway invlovement , chest discomfort, respiratory symptoms, nausea and abdominal cramping
Pretreatment with antihistamines and rate of infusion reduced rate of infusion have allowed the
use of alglucerase in patients
Additional adverse reactions-
CNS - dysomia, fatigue, head ache, light headedness, weakness
GI - diarrhea, oral ulceration
GU - menstrual abnormalites and false positive tests have been reported
Musculoskeletal- backache
Miscellaneous- transcient peripheral edema, vasomotor irritability or hot flash.
Contra-Indications:
Special precautions-
Antibodies- patients with antibodies to algucerase are at a higher risk of hypersensitivity reactions
If a patient experienced a reaction suggestive of symptoms of hypersensitivity, it is recommended
that a serum samplefor tryptase levels and complement activiation be drawn within 2 hrs of reaction
after appropiate treatment of symptoms.
Subsequent serum for testing antibody to alglucerase would be helpful.
Pretreatment- pretreatment with antihistamines has allowed the use of alglucerase in some patients
Transmission of viral disease- algucerase is prepared from pooled human placental tissues
that may contain the causative agents of some viral diseases.Manufacturing steps have been
designed to reduce the risk of transmitting infectious agents.
Access the benefits and risks of treatment with this product prior to use.
Hypersensitivity reactions- approach treatment with alglucerase with caution in patients who
have exhibited symptoms of hypersensitivity to the product.
Special risk- use alglucerase with cautionn in patients with androgen sensitive malignancies
eg prostrae cancer and patients with known prior allergies to hCG
Pregnancy- prescribe algulcerase to a pregnant woman only if clearly needed
Lactation- excercise caution when alglucerase is administered to a breast feeding woman
Children- safety and efficay of alglucerase have been established in children between 2 and
16 years of age. Algulcerase has been administered to children below 2 years of age, however,
safety and efficacy in patients younger than 2 years have not been established.
Monitoring- periodically monitor patients for IgG antibody formation
A heathcare priovider knowledgeable in the management of patients with Glaucher disease
should direct therapy with algucerase
Dosages/ Overdosage Etc:
Indication-
Gaucher Disease Type 1
Dosage- Allucerase is administered by IV infusion over a period of 1 to 2 hours.
Dosage should be individualized for each patient..
Intial dose should be as little as 2.5 units/kg of body weight 3 times a week, and as much as
60units/kg administered as frequently as once a week or as infrequently as every 4 weeks
Progressive reductions can be made at intervals of 3 to 6 months while carefully monitoring the
response of the parameters
Patient Information:
Algucerase- Systemic
1. Advice patients that this medicine is usually administered as a injection at the health care providers office, hospital or clinic. If they are to use this medicine at home, advice patients to carefully follow the injection procedures taught by their health care provider
2. Advice patients not to drive, operate machinery, or do anything else that could be
dangerous until they know how they react to this medicine
3.Allergies-
Tell your doctor if you have ever any unusual or allergic reaction to alglucerase.
Also tell your healthcare professional if you are allergic to any other substances
such as foods, preservatives or dyes.
4.Pregnancy-
Studies have not been in humans or animals
5.Breast-feeding-
It is not known whether alglucerase passes into humn breast milk.
6.Children-
This medicine has been tested in a limited number of children. In effective doses,
the medicine has not been shown to cause different side effects or problem that
it does in adults
7.Older adults-
Many medicines have not been studied specifically in older people. Therefore
it is not known whether they work exactly in the same manner as they do in
younger adults or if they cause different side effects or problems in older people.
There is no specific information comparing use of alglucerse in the elderly with
use in other age groups.
8.Other medicines-
Although crertain medicines should not be used together at all, in other cases
two different medicines may be used together even if an interaction might occur.
In these cases your doctor may want tochange the dose , or other precautions
may be necessary. Tell your doctor if you are taking any other prescription or
non-prescription (over-the counter OTC) medicines
Pharmacology/ Pharmacokinetics:
Pharmacolgy-
Algucerase catayses the hydrolysis of the glycolip glucerebroside to glucose and ceramide as
a part of normal degradation pathway for membrane and lipds
Gaucher disease is characterized by functional deficiency in beta-glucocerebrosidase enzymatic
activity and the resultant accumulation of lipid glucocerbroside in the tissue macrophanges,
which becomes engroged and are termed as Gaucher cells.
Gaucher cells are typically found in liver, spleen, and bone marrow and occasonally in the luing,
kidney, and intestine
Pregnancy and lactation:
Pregnancy-
Prescribe algulcerase to a pregnant woman only if clearly needed
Lactation-
Excercise caution when alglucerase is administered to a breast feeding woman
Children-
Safety and efficay of alglucerase have been established in children between 2 and
16 years of age. Algulcerase has been administered to children below 2 years of age, however,
safety and efficacy in patients younger than 2 years have not been established.
Monitoring-
Periodically monitor patients for IgG antibody formation
A heathcare priovider knowledgeable in the management of patients with Glaucher disease
should direct therapy with algucerase
Manufacturer Details