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ELELYSO®(taliglucerase alfa)
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Our medical information is accurate, up to date, and scientifically balanced.
ELELYSO® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
ELELYSO is indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage in Patients 4 Years and Older
Treatment-...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 200 units white to off-white lyophilized powder in a single-dose vial for reconstitution.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions Including Anaphylaxis
Serious hypersensitivity reactions, including anaphylaxis, have occurred in some...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
The limited available...
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Description
11 DESCRIPTION
Taliglucerase alfa is a hydrolytic lysosomal glucocerebroside-specific enzyme produced by recombinant DNA technology using plant cell culture (carrot). Taliglucerase alfa is a monomeric glycoprotein enzyme...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Gaucher disease is an autosomal recessive disorder caused by mutations in the human glucocerebrosidase gene, which...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential or studies to...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Clinical Trials of ELELYSO as Initial Therapy
Clinical Trial in...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
ELELYSO (taliglucerase alfa) for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose vial. Each vial of ELELYSO contains 200...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Hypersensitivity Reactions Including Anaphylaxis
Advise patients and caregivers that reactions related to...
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