Cerezyme

Drug overview for CEREZYME (imiglucerase):

Generic name: IMIGLUCERASE (im-eh-GLUE-ser-aze)
Drug class: Metabolic Disease Enzyme Replacement, Gaucher's Disease
Therapeutic class: Metabolic Disease Enzyme Replacement Agents

Imiglucerase is a biosynthetic (recombinant DNA origin) form of human beta-glucocerebrosidase, a lysosomal enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide.

No enhanced Uses information available for this drug.

DRUG IMAGES

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The following indications for CEREZYME (imiglucerase) have been approved by the FDA:

Indications:
Gaucher's disease

Professional Synonyms:
Cerebroside lipidosis
Familial splenic anemia
Type 1 Gaucher disease

Dosing information for CEREZYME
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CEREZYME 400 UNIT VIAL	Maintenance	Adults infuse 2.5 unit/kg over 1-2 hour(s) by intravenous route 3 times per week

Moderate List
No disease contraindications

The following adverse reaction information is available for CEREZYME (imiglucerase):

Overview
Severe
Less Severe

Adverse reaction overview.

The most common adverse effects reported in adult patients administered imiglucerase include back pain, chills, dizziness, fatigue, headache, hypersensitivity reactions, nausea, pyrexia, and vomiting. Adverse effects reported in pediatric patients >=2 years of age are similar to adults.

There are 7 severe adverse reactions.

More Frequent	Less Frequent
Tachycardia	None.

Rare/Very Rare
Anaphylaxis Angioedema Cyanosis Dyspnea Hypersensitivity drug reaction Urticaria

There are 15 less severe adverse reactions.

More Frequent	Less Frequent
Back pain Chills Diarrhea Fatigue Fever	Abdominal pain with cramps Dizziness Headache disorder Hypotension Nausea Pruritus of skin Skin rash

Rare/Very Rare
Flushing Hypertension Injection site sequelae

The following precautions are available for CEREZYME (imiglucerase):

Pediatric
Pregnant
Lactation
Geriatric

Use of imiglucerase in pediatric patients >=2 years of age is principally supported by evidence from adequate and well-controlled studies of the drug and its predecessor (alglucerase (Ceredase(R); no longer commercially available in the US)) in adults and pediatric patients >=12 years of age with additional data obtained from the medical literature and postmarketing experience in pediatric patients as young as 2 years of age. Safety and efficacy of imiglucerase have not been established in children younger than 2 years of age.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

No drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes was identified in pregnant women from clinical data within the international Gaucher disease registry, postmarketing reports, observational studies, and case reports. Adverse pregnancy outcomes may occur due to untreated Gaucher disease. Pregnant women exposed to imiglucerase and clinicians are encouraged to contact the Gaucher patient registry by calling 1-800-745-4447 ext.

15500 or visiting https://www.registrynxt.com.

Clinical data suggest a small amount of imiglucerase is present in human milk immediately following an infusion. No adverse effects were reported in breastfed infants of lactating women administered imiglucerase in published postmarketing and case reports. There are no data on the effects of imiglucerase on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for imiglucerase and any potential adverse effects on the breastfed child from the drug or the underlying maternal condition. Lactating women with Gaucher disease treated with imiglucerase are encouraged to enroll in the Gaucher patient registry by calling 1-800-745-4447 ext. 15500 or visiting https://www.registrynxt.com.

No enhanced Geriatric Use information available for this drug.