Avalglucosidase alfa-ngpt
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Avalglucosidase alfa-ngpt is a hydrolytic lysosomal glycogen-specific enzyme that is FDA approved for the treatment of late-onset Pompe disease. There is a Black Box Warning for this drug as shown here. Common adverse reactions include erythema, pruritus, urticaria, nausea, headache, dizziness, paresthesia, myalgia, arthralgia, diarrhea, dyspnea, and vomiting.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Recommended Dosage and Administration
- Avalglucosidase_alfa-ngpt dosage is given through an intravenous infusion and is based on a patients body weight.
- Avalglucosidase_alfa-ngpt should be both diluted and reconstituted before administering dosage into patients.
- Use of antipyretics, corticosteroids, or antihistamines may be used before the administration of Avalglucosidase_alfa-ngpt dosage into patients.
- The recommended dosage of patients ≥30 kg is 20 mg/kg every 2 weeks.
- The recommended dosage of patients <30 kg is 40 mg/kg every 2 weeks.
- 1 mg/kg/hour is the initial infusion rate that should be gradually increased every 30 minutes if there are no IARs seen in patients.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Avalglucosidase alfa-ngpt in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Avalglucosidase alfa-ngpt in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Avalglucosidase alfa-ngpt 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 Avalglucosidase alfa-ngpt in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Avalglucosidase alfa-ngpt in pediatric patients.
Contraindications
There is limited information regarding Avalglucosidase alfa-ngpt Contraindications in the drug label.
Warnings
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TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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There is limited information regarding Avalglucosidase alfa-ngpt Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Avalglucosidase alfa-ngpt Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Avalglucosidase alfa-ngpt Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Avalglucosidase alfa-ngpt Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Avalglucosidase alfa-ngpt in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Avalglucosidase alfa-ngpt in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Avalglucosidase alfa-ngpt during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in geriatric settings.
Gender
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt with respect to specific gender populations.
Race
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Avalglucosidase alfa-ngpt in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Avalglucosidase alfa-ngpt in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Avalglucosidase alfa-ngpt Administration in the drug label.
Monitoring
There is limited information regarding Avalglucosidase alfa-ngpt Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Avalglucosidase alfa-ngpt and IV administrations.
Overdosage
There is limited information regarding Avalglucosidase alfa-ngpt 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 Avalglucosidase alfa-ngpt Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Avalglucosidase alfa-ngpt Mechanism of Action in the drug label.
Structure
There is limited information regarding Avalglucosidase alfa-ngpt Structure in the drug label.
Pharmacodynamics
There is limited information regarding Avalglucosidase alfa-ngpt Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Avalglucosidase alfa-ngpt Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Avalglucosidase alfa-ngpt Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Avalglucosidase alfa-ngpt Clinical Studies in the drug label.
How Supplied
There is limited information regarding Avalglucosidase alfa-ngpt How Supplied in the drug label.
Storage
There is limited information regarding Avalglucosidase alfa-ngpt 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 Avalglucosidase alfa-ngpt Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Avalglucosidase alfa-ngpt 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 Avalglucosidase alfa-ngpt Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Avalglucosidase alfa-ngpt 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.