| U.S. Brand Names |
| Ceredase® |
 |
| Generic Available |
|
No |
|
| Synonyms |
| Glucocerebrosidase |
|
| Pharmacological Index |
|
Enzyme |
|
| Use |
|
Orphan drug: Treatment of Gaucher's disease |
|
| Pregnancy Risk Factor |
|
C |
|
| Contraindications |
|
Hypersensitivity to any component |
|
| Warnings/Precautions |
|
Prepared from pooled human placental tissue that may contain the causative agents of some viral diseases |
|
| Adverse Reactions |
|
>10%: Local: Discomfort, burning, and edema at the site of injection <1%: Fever, chills, abdominal discomfort, nausea, vomiting |
|
| Overdosage/Toxicology |
|
No obvious toxicity was detected after single doses of up to 234 units/kg |
|
| Stability |
|
Refrigerate (4°C), do not shake |
|
| Mechanism of Action |
|
Glucocerebrosidase is an enzyme prepared from human placental tissue. Gaucher's disease is an inherited metabolic disorder caused by the defective activity of beta-glucosidase and the resultant accumulation of glucosyl ceramide laden macrophages in the liver, bone, and spleen; acts by replacing the missing enzyme associated with Gaucher's disease. |
|
| Pharmacodynamics/Kinetics |
|
Half-life, elimination: ~4-20 minutes |
|
| Usual Dosage |
|
Usually administered as a 20-60 unit/kg I.V. infusion given with a frequency ranging from 3 times/week to once every 2 weeks |
|
| Mental Health: Effects on Mental Status |
|
None reported |
|
| Mental Health: Effects on Psychiatric Treatment |
|
None reported |
|
| Dental Health: Local Anesthetic/Vasoconstrictor Precautions |
|
No information available to require special precautions |
|
| Dental Health: Effects on Dental Treatment |
|
No effects or complications reported |
|
| Patient Information |
|
Treatment is required for life. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding. |
|
| Nursing Implications |
|
Parenteral: Dilute to a final volume of 100 mL or less of normal saline and infuse I.V. over 1-2 hours; an in-line filter should be used; do not shake solution as it denatures the enzyme Monitor CBC, platelets, liver function tests |
|
| Dosage Forms |
|
Injection: 10 units/mL (5 mL); 80 units/mL (5 mL) |
|
| 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. Whittington R and Goa KL, "Alglucerase: A Review of Its Therapeutic Use in Gaucher's Disease," Drugs, 1992, 44(1):72-93. |
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