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Alglucerase


Pronunciation

 (al GLOO ser ase)


U.S. Brand Names

 Ceredase®


Synonyms

 Glucocerebrosidase


Generic Available

 No


Use

 Replacement therapy for Gaucher's disease (type 1)


Pregnancy Risk Factor

 C


Pregnancy Implications

 Animal studies have not been conducted.


Lactation

 Excretion in breast milk unknown/use caution


Contraindications

 Hypersensitivity to any component of the formulation


Warnings/Precautions

 Prepared from pooled human placental tissue that may contain the causative agents of some viral diseases. Patients who develop IgG antibodies may be at a higher risk for developing hypersensitivity. Use caution with androgen sensitive malignancies or prior allergies to hCG. May cause early virilization in males <10 years of age.


Adverse Reactions

 Frequency not defined.

Cardiovascular: Peripheral edema

Central nervous system: Chills, fatigue, fever, headache, lightheadedness

Endocrine & metabolic: Hot flashes, menstrual abnormalities

Gastrointestinal: Abdominal discomfort, diarrhea, nausea, oral ulcerations, vomiting

Local: Injection site: Abscess, burning, discomfort, pruritus, swelling

Neuromuscular & skeletal: Backache, weakness

Miscellaneous: Dysosmia; hypersensitivity reactions (abdominal cramping, angioedema, chest discomfort, flushing, hypotension, nausea, pruritus, respiratory symptoms, urticaria); IgG antibody formation (~13%)


Overdosage/Toxicology

 No obvious toxicity has been detected after single doses up to 234 units/kg.


Stability

 Refrigerate (4°C), do not freeze. Contains no preservatives. Do not store opened vials for future use. Dilute with NS to a final volume 200 mL. Do not shake. Once diluted, 100 mL and 200 mL solutions for infusion are stable for 18 hours when stored at 2°C to 8°C.


Compatibility

 Compatible: Stable in NS


Mechanism of Action

 Alglucerase is a modified form of glucocerebrosidase; it is prepared from human placental tissue. Glucocerebrosidase is an enzyme deficient in Gaucher's disease. It is needed to catalyze the hydrolysis of glucocerebroside to glucose and ceramide.


Pharmacodynamics/Kinetics

 Half-life elimination: ~3-11 minutes


Dosage

 I.V.: Children and Adults: Initial: 30-60 units/kg every 2 weeks; dosing is individualized based on disease severity; average dose: 60 units/kg every 2 weeks. Range: 2.5 units/kg 3 times/week to 60 units/kg 1-4 times/week. Once patient response is well established, dose may be reduced every 3-6 months to determine maintenance therapy.


Administration

 I.V.: Infuse I.V. over 1-2 hours; use of an in-line filter is recommended; do not shake solution as it denatures the enzyme


Monitoring Parameters

 CBC, platelets, liver function tests, IgG antibody formation, acid phosphatase (AP); MRI or CT of liver and spleen, skeletal x-rays, physical exam every 6-12 months


Test Interactions

 False positive pregnancy tests


Patient Education

 Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. This medication will not cure Gaucher's disease, but rather, may help control it. Treatment is required for life. May cause abdominal discomfort, nausea, or vomiting (small, frequent meals, good mouth care, chewing gum, or sucking lozenges may help); these symptoms should go away with continued use. Inform prescriber if pain, swelling, or redness occurs at injection site or if GI symptoms persist. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.


Dental Health: Effects on Dental Treatment

 No significant effects or complications reported


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 No information available to require special precautions


Mental Health: Effects on Mental Status

 None reported


Mental Health: Effects on Psychiatric Treatment

 None reported


Dosage Forms

 Injection, solution [preservative free]: 10 units/mL (5 mL); 80 units/mL (5 mL) [contains human albumin 1%]


References

Barton NW, Brady RO, Dambrosia JM, et al, "Replacement Therapy for Inherited Enzyme Deficiency - Macrophage-Targeted Glucocerebrosidase for Gaucher's Disease," N Engl J Med , 1991, 324(21):1464-70.

Charrow J, Andersson HC, Kaplan P, et al, "Enzyme Replacement Therapy and Monitoring for Children With Type 1 Gaucher Disease: Consensus Recommendations," J Pediatr , 2004, 144(1):112-20.

Whittington R and Goa KL, "Alglucerase: A Review of Its Therapeutic Use in Gaucher's Disease," Drugs , 1992, 44(1):72-93.


International Brand Names

 Ceredase® (IL)


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