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Cerezyme
imiglucerase
Black Box Warnings .
Hypersensitivity Reaction
life-threatening reactions including anaphylaxis have occurred; anaphylaxis has occurred during early tx and after extended tx duration; administer where appropriate medical support including cardiopulmonary resuscitation equip. available; D/C immediately and start appropriate tx if severe reaction occurs; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Adult Dosing .
Dosage forms: INJ
Gaucher disease, type 1 or type 3
- [2.5 units/kg/dose IV 3x/wk up to 60 units/kg/dose IV q2wk]
- Info: for non-CNS manifestations; individualize dose, frequency based on disease severity, clinical response; if switching from another enzyme replacement tx, start with previous enzyme replacement dose 2wk after last administration; premed with antihistamine and/or corticosteroid if hypersensitivity reaction
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
Gaucher disease, type 1 or type 3
- [2.5 units/kg/dose IV 3x/wk up to 60 units/kg/dose IV q2wk]
- Info: for non-CNS manifestations; individualize dose, frequency based on disease severity, clinical response; if switching from another enzyme replacement tx, start with previous enzyme replacement dose 2wk after last administration; premed with antihistamine and/or corticosteroid if hypersensitivity reaction
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- caution: hypersensitivity to drug or ingredient
Drug Interactions .
Overview
imiglucerase
metabolic enzyme
-
None
Caution Advised
- miglustat
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- infusion reaction, severe
Common Reactions
- hypersensitivity reaction
- headache
- abdominal pain
- back pain
- nausea
- vomiting
- fever
- dizziness
- diarrhea
- arthralgia
- URI
- infusion reaction
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no known risk of fetal harm based on limited human data
Pregnancy Registry
enroll patients or encourage patients to enroll in Gaucher Patient Registry at 1-800-745-4447 ext. 15500 or at www.registrynxt.com
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data and drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for imiglucerase: unknown; CYP450: unknown
Excretion: for imiglucerase: unknown: Half-life: 3.6-10.4min
Subclass: Inherited Metabolic Disorders
Mechanism of Action
for imiglucerase: catalyzes hydrolysis of glucocerebroside to glucose and ceramide, reducing accumulated lysosomal glucocerebroside
Formulary .
No Formulary Selected
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