Pegunigalsidase alfa-iwxj

Pegunigalsidase alfa-iwxj
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: Alen Antony Pathil, M.D.[2]

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Black Box Warning

HYPERSENSITIVITY REACTIONS including Anaphylaxis See full prescribing information for complete Boxed Warning. Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment. Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.

Overview

Pegunigalsidase alfa-iwxj is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of Fabry's disease in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include infusion-associated reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, and sinusitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Pegunigalsidase alfa-iwxj Contraindications in the drug label.

Warnings

HYPERSENSITIVITY REACTIONS including Anaphylaxis See full prescribing information for complete Boxed Warning. Patients may experience hypersensitivity reaction including anaphylaxis during the treatment course with ELFABRIO. Therefore, a cardiopulmonary resuscitation kit should always available while administering the treatment. Patients who develop hypersensitivity reaction symptoms should immediately discontinue the treatment of ELFABRIO. Furthermore, they should undergo desensitization procedure to ELFABRIO.

There is limited information regarding Pegunigalsidase alfa-iwxj Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Pegunigalsidase alfa-iwxj Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Pegunigalsidase alfa-iwxj Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Pegunigalsidase alfa-iwxj Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

There is no FDA guidance on use of Pegunigalsidase alfa-iwxj during labor and delivery.

Nursing Mothers

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

Pediatric Use

There is no FDA guidance on the use of Pegunigalsidase alfa-iwxj in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Pegunigalsidase alfa-iwxj in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Pegunigalsidase alfa-iwxj Administration in the drug label.

Monitoring

There is limited information regarding Pegunigalsidase alfa-iwxj Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Pegunigalsidase alfa-iwxj and IV administrations.

Overdosage

There is limited information regarding Pegunigalsidase alfa-iwxj 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 Pegunigalsidase alfa-iwxj Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Pegunigalsidase alfa-iwxj Mechanism of Action in the drug label.

Structure

There is limited information regarding Pegunigalsidase alfa-iwxj Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pegunigalsidase alfa-iwxj Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Pegunigalsidase alfa-iwxj Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Pegunigalsidase alfa-iwxj Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Pegunigalsidase alfa-iwxj Clinical Studies in the drug label.

How Supplied

There is limited information regarding Pegunigalsidase alfa-iwxj How Supplied in the drug label.

Storage

There is limited information regarding Pegunigalsidase alfa-iwxj 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 Pegunigalsidase alfa-iwxj Patient Counseling Information in the drug label.

Precautions with Alcohol

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

Brand Names

There is limited information regarding Pegunigalsidase alfa-iwxj Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Pegunigalsidase alfa-iwxj 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.