Elapegademase-lvlr

Class: Enzymes
Chemical Name: Poly(oxy-1,2-ethanediyl), α-carboxy-ω-methoxy-, amide with adenosine deaminase (synthetic)
Molecular Formula: C₁₇₉₇H₂₇₉₅N₄₇₇O₅₄₄S₁₂
CAS Number: 1709806-75-6
Brands: Revcovi

Medically reviewed by Drugs.com on Oct 19, 2021. Written by ASHP.

Introduction

Elapegademase-lvlr is an enzyme.

Uses for Elapegademase-lvlr

Elapegademase-lvlr has the following uses:

Elapegademase-lvlr is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Elapegademase-lvlr Dosage and Administration

General

Elapegademase-lvlr is available in the following dosage form(s) and strength(s):

Injection: 2.4 mg/1.5 mL (1.6 mg/mL) in a single-dose vial.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

• The treatment of ADA-SCID with elapegademase-lvlr should be monitored by measuring trough plasma adenosine deaminase (ADA) activity, trough deoxyadenosine nucleotide (dAXP) levels, and/or total lymphocyte counts. Monitoring should be more frequent if therapy was interrupted or if an enhanced rate of clearance of plasma ADA activity develops. See full prescribing information for specific instructions on therapeutic drug monitoring of elapegademase-lvlr, including target trough ADA activity and dAXP levels and recommended monitoring schedules.

• Collect blood samples for the analysis of trough plasma ADA activity and trough dAXP level prior to the first administration of elapegademase-lvlr for the week.

Pediatric Patients

Elapegademase-lvlr is for intramuscular (IM) injection only. See full prescribing information for specific instructions on preparation and administration of the IM injection. Follow sterile IM administration technique guidelines appropriate to the patient’s age and anatomy (i.e., choice of needle gauge and length, site of administration). Take precautions not to inject into or near an artery or nerve. Alternate the injection site periodically.

Patients transitioning from Adagen (pegademase bovine) to elapegademase-lvlr:

If a patient’s weekly Adagen dose is unknown, or a patient’s weekly Adagen dose is at or lower than 30 units/kg, the recommended minimum starting dose of elapegademase-lvlr is 0.2 mg/kg, intramuscularly, once a week.

If a patient’s weekly Adagen dose is above 30 units/kg, an equivalent weekly elapegademase-lvlr dose (mg/kg) should be calculated using the following conversion formula:

elapegademase-lvlr dose in mg/kg = pegademase bovine dose (in units/kg) / 150

Subsequent doses may be increased by increments of 0.033 mg/kg weekly if trough ADA activity is under 30 mmol/hr/L, trough dAXP levels are above 0.02 mmol/L, and/or the immune reconstitution is inadequate based on the clinical assessment of the patient. The total weekly dose may be divided into multiple IM a...