Alglucosidase alfa

Alglucosidase alfa
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sree Teja Yelamanchili, MBBS [2]

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Black Box Warning

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE See full prescribing information for complete Boxed Warning. * Life-threatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema, and face edema), and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following alglucosidase alfa treatment. Closely observe patients during and after alglucosidase alfa administration and be prepared to manage anaphylaxis and hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated reactions and have them seek immediate medical care should signs and symptoms occur. Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring.

Overview

Alglucosidase alfa is an enzyme replacement therapy that is FDA approved for the treatment of patients with Pompe disease (GAA deficiency-Glycogen storage disease-type ii). There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Alglucosidase alfa FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alglucosidase alfa in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alglucosidase alfa in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Alglucosidase alfa FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Alglucosidase alfa in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Alglucosidase alfa in pediatric patients.

Contraindications

There is limited information regarding Alglucosidase alfa Contraindications in the drug label.

Warnings

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE See full prescribing information for complete Boxed Warning. * Life-threatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema, and face edema), and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following alglucosidase alfa treatment. Closely observe patients during and after alglucosidase alfa administration and be prepared to manage anaphylaxis and hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated reactions and have them seek immediate medical care should signs and symptoms occur. Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring.

There is limited information regarding Alglucosidase alfa Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Alglucosidase alfa Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Alglucosidase alfa Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Alglucosidase alfa Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Alglucosidase alfa in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alglucosidase alfa in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Alglucosidase alfa during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Alglucosidase alfa in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Alglucosidase alfa in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Alglucosidase alfa in geriatric settings.

Gender

There is no FDA guidance on the use of Alglucosidase alfa with respect to specific gender populations.

Race

There is no FDA guidance on the use of Alglucosidase alfa with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Alglucosidase alfa in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Alglucosidase alfa in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Alglucosidase alfa in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Alglucosidase alfa in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Alglucosidase alfa Administration in the drug label.

Monitoring

There is limited information regarding Alglucosidase alfa Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Alglucosidase alfa and IV administrations.

Overdosage

There is limited information regarding Alglucosidase alfa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Alglucosidase alfa Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Alglucosidase alfa Mechanism of Action in the drug label.

Structure

There is limited information regarding Alglucosidase alfa Structure in the drug label.

Pharmacodynamics

There is limited information regarding Alglucosidase alfa Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Alglucosidase alfa Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Alglucosidase alfa Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Alglucosidase alfa Clinical Studies in the drug label.

How Supplied

There is limited information regarding Alglucosidase alfa How Supplied in the drug label.

Storage

There is limited information regarding Alglucosidase alfa Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Alglucosidase alfa Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Alglucosidase alfa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Alglucosidase alfa Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Alglucosidase alfa Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Alglucosidase alfa

Clinical data
ATC code	A16AB07 (WHO)
Identifiers
CAS Number	[1] 420794-05-0
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C4758H7262N1274O1369S35
Molar mass	105338

Alglucosidase alfa (Myozyme) is a drug used to treat Glycogen storage disease type II (Pompe's disease). It is an analogue of acid alpha-glucosidase.

Some health plans have refused to pay for Myozyme, because it costs $300,000 a year for adults, and has only been approved by the F.D.A. for use in infants.