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Loargys (pegzilarginase-nbln)
pegzilarginase
Black Box Warnings .
Hypersensitivity Reaction
life-threatening reactions including anaphylaxis have occurred; anaphylaxis has occurred during early tx and after extended tx duration; initiate tx in healthcare setting where appropriate medical support including cardiopulmonary resuscitation equipment available; D/C immediately and start appropriate tx if severe reaction occurs; counsel patients on signs/symptoms and to seek immediate medical attention if they occur at any time
Adult Dosing .
Dosage forms: INJ: 2 mg per 0.4 mL, 5 mg per mL
Restricted Distribution in US
- [1-844-627-4687 for more info]
- Info: only available to patients enrolled in Study IMM-PEG-005
Special Note
- [drug name clarification]
- Info: nonproprietary name = pegzilarginase-nbln
arginase 1 deficiency
- [individualize dose SC/IV qwk]
- Start: 0.1 mg/kg/dose IV qwk; Max: 0.2 mg/kg/wk; Info: consider premed with antihistamine (and corticosteroid if hypersensitivity reaction); if 2 consecutive weekly pre-dose plasma arginine levels <50 micromolar, decr. dose by 0.05 mg/kg/wk; if 2 consecutive weekly pre-dose plasma arginine levels >150 micromolar, incr. dose by 0.05 mg/kg/wk; separate doses by >4 days; may switch to SC route after 8wk of IV administration
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ: 2 mg per 0.4 mL, 5 mg per mL
Restricted Distribution in US
- [1-844-627-4687 for more info]
- Info: only available to patients enrolled in Study IMM-PEG-005
Special Note
- [drug name clarification]
- Info: nonproprietary name = pegzilarginase-nbln
arginase 1 deficiency
- [2 yo and older]
- Dose: individualize dose SC/IV qwk; Start: 0.1 mg/kg/dose IV qwk; Max: 0.2 mg/kg/wk; Info: consider premed with antihistamine (and corticosteroid if hypersensitivity reaction); if 2 consecutive weekly pre-dose plasma arginine levels <50 micromolar, decr. dose by 0.05 mg/kg/wk; if 2 consecutive weekly pre-dose plasma arginine levels >150 micromolar, incr. dose by 0.05 mg/kg/wk; separate doses by >4 days; may switch to SC route after 8wk of IV administration
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- caution: hypersensitivity to drug or ingredient
Drug Interactions .
Overview
pegzilarginase
metabolic enzyme
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
Common Reactions
- vomiting
- fever
- infusion reaction (IV use)
- constipation
- injection site reaction (SC use)
- hypersensitivity reaction
- dizziness
- nasopharyngitis
- rhinorrhea
- ALT or AST incr.
Safety/Monitoring .
Monitoring Parameters
plasma arginine at baseline, 4wk after tx start, then qwk x2wk after dose adjustment and as clinically indicated
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; possible risk of fetal malformations and decr. fetal wt based on animal data at 3x and 8x MRHD
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for pegzilarginase: catabolism; CYP450: unknown
Excretion: for pegzilarginase: unknown; Half-life: 50h
Subclass: Inherited Metabolic Disorders
Mechanism of Action
for pegzilarginase: replaces deficient human arginase 1 enzyme, reducing plasma arginine
Formulary .
No Formulary Selected
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