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ELELYSO®(taliglucerase alfa)

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ELELYSO® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Patients 4 Years and Older

Treatment-...

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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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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions Including Anaphylaxis

Serious hypersensitivity reactions, including anaphylaxis, have occurred in some...

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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available...

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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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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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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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14 CLINICAL STUDIES

14.1 Clinical Trials of ELELYSO as Initial Therapy

Clinical Trial in...

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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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17 PATIENT COUNSELING INFORMATION

Hypersensitivity Reactions Including Anaphylaxis

Advise patients and caregivers that reactions related to...

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Manufactured by
Pfizer Inc.
NY, NY 10017
US License No. 2001

...

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