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ELELYSO®(taliglucerase alfa)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ELELYSO® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Pretreatment to Reduce Risk of Hypersensitivity Reactions
To reduce the risk of...
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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
Hypersensitivity reactions, including serious hypersensitivity reactions such as...
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Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying...
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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...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.