CEREZYME- imiglucerase injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IMIGLUCERASE (UNII: Q6U6J48BWY) (IMIGLUCERASE - UNII:Q6U6J48BWY)

Available from:

Genzyme Corporation

INN (International Name):

IMIGLUCERASE

Composition:

IMIGLUCERASE 40 U in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cerezyme is indicated for treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions: - anemia - thrombocytopenia - bone disease - hepatomegaly or splenomegaly None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Cerezyme during pregnancy. Pregnant women exposed to Cerezyme and health care providers are encouraged to contact the Gaucher patient registry at 1-800-745-4447, extension 15500 or visit www.registrynxt.com. Risk Summary Available data on more than 500 pregnancies from the international Gaucher Disease registry, postmarketing reports, published observational studies and case reports with Cerezyme or non–US-licensed imiglucerase use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks associated with symptomatic Type I Gaucher disease

Product summary:

Cerezyme (imiglucerase) for injection, 400 units as a white to off-white lyophilized powder in a single-dose vial: NDC 58468-4663-1 Store refrigerated at 2°C to 8°C (36°F to 46°F). For storage of reconstituted and diluted solution see [Dosage and Administration (2.2)] .

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CEREZYME- IMIGLUCERASE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GENZYME CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEREZYME SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEREZYME.
CEREZYME (IMIGLUCERASE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Cerezyme is a hydrolytic lysosomal glucocerebrosidase-specific enzyme
indicated for treatment of adults
and pediatric patients 2 years of age and older with Type 1 Gaucher
disease that results in one or more of
the following conditions: anemia, thrombocytopenia, bone disease,
hepatomegaly or splenomegaly. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dosage ranges from 2.5 units/kg three times a week to
60 units/kg once every two
weeks. ( 2.1)
Cerezyme is administered by intravenous infusion over 1 to 2 hours. (
2.1)
Titrate the dosage based on clinical manifestations of disease and
therapeutic goals for the patient. (
2.1)
See the full prescribing information for preparation and
administration instructions. ( 2.2)
DOSAGE FORMS AND STRENGTHS
For injection: 400 units of imiglucerase as a lyophilized powder in a
single-dose vial. ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Hypersensitivity and Infusion-Associated Reactions: Consider periodic
monitoring of patients during the
first year of treatment for IgG antibody formation. If a severe
hypersensitivity reaction occurs,
discontinue Cerezyme treatment and initiate appropriate medical
treatment. ( 5.1)
ADVERSE REACTIONS
Adverse reactions reported in adults include back pain, chills,
dizziness, fatigue, headache,
hypersensitivity reactions, nausea, pyrexia, and vomiting. ( 6.1)
Adverse reactions reported in pediatric patients 2 years of age and
older are similar to adults. ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GENZYME AT
1-800-745-4447 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2021
FULL PR