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Loargys pegzilarginase-nbln 2 mg/.4mL Injection, 1 vial — NDC 81583-102-01 (Billing 81583-0102-01)

by Immedica Pharma US Inc. · 1 VIAL in 1 CARTON / .4 mL in 1 VIAL

This is a package of 1 vial of Loargys pegzilarginase-nbln 2 mg/.4mL Injection from Immedica Pharma US Inc., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 81583-0102-01
🏷️ FDA NDC (as labeled) 81583-102-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 81583-102-01
Product NDC 81583-102
11-digit billing NDC 81583010201
NCPDP billing unit ML — per mL (volume)
RxCUI 2738655, 2738662, 2738664, 2738665
UNII 4YV4KW88GD
Application # BLA761211
SPL Set ID d5ceabf2-43a0-4746-9371-d98a39cf6cfc
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-09
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION
Substance PEGZILARGINASE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 30902760002020
GCN Seq No 087056
GCN 56892
HICL code 050171
Ingredient (HICL) Pegzilarginase-Nbln
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code ZA
Therapeutic class — intermediate (HIC2) Drugs Having Action On Wide-Spread Tissue (Cont 1)
HIC3 code ZAJ
Therapeutic class — specific (HIC3) Metabolic Disease Enzyme Replacement,Arginase Def.
AHFS code 44:00.00.00
AHFS class Enzymes
FDB label name LOARGYS 2 MG/0.4 ML VIAL
FDB brand name Loargys
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087056
  • GCN: 56892
  • GPI-14 (Medi-Span): 30902760002020
  • HICL (First Databank): 050171
  • AHFS class code: 44:00.00.00
  • RxCUI (RxNorm): 2738655
Why two NDCs? The FDA registers this code as 81583-102-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 81583-0102-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Enzymes class.

Drug family (ATC) Enzymes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name LOARGYS 2 MG/0.4 ML VIAL Ingredient Pegzilarginase-Nbln
📖 What it is MedlinePlus · NLM

Pegzilarginase-nbln is used to treat Arinase 1 Deficiency (ARG 1-D; an inherited condition with a partial or complete lack of the enzyme arginase in the body). Pegzilarginase-nbln is in a class of medications called enzymes. It works by reducing the amount of arginine in the body.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
81583-0102-01 You're viewing this Main listing 1 VIAL in 1 CARTON / .4 mL in 1 VIAL 2026-03-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loargys 2 mg/.4mLthis 81583-0102-01 Immedica 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII CI71S98N1Z
    A mineral salt containing potassium and phosphate, used as a buffer to help maintain the medicine's pH level and stability during storage.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 4J9FJ0HL51
    Potassium phosphate, monobasic is a salt compound used in medicines as a pH buffer and electrolyte source. It helps stabilize the acidity level of liquid and powdered formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerImmedica Pharma US Inc.
FDA applicationBLA761211 (BLA)
Labeler code81583
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio2 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 160 words ▾

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LOARGYS in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment.

If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, discontinue LOARGYS and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions ( 5.1 )] . WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning.

Initiate LOARGYS in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. ( 5.1 ) If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, discontinue LOARGYS, and immediately initiate appropriate medical treatment, including use of epinephrine. ( 5.1 )

🎯 Indications and Usage 148 words ▾

1 INDICATIONS AND USAGE LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

LOARGYS is an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. ( 1 ) This indication is approved under accelerated approval based on reduction of plasma arginine. ( 14 ) Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Administer LOARGYS under the supervision of a health care provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. ( 2.1 ) • Initiate LOARGYS in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. ( 2.1 ) • Consider pre‑medication with antihistamines.

( 2.1 ) • Obtain a baseline plasma arginine concentration prior to initiating treatment. ( 2.1 ) • Recommended starting dosage of LOARGYS is 0.1 mg/kg administered by intravenous infusion once weekly. ( 2.2 ) • Maximum recommended dosage is 0.2 mg/kg once weekly.

( 2.2 ) • See the Full Prescribing Information for recommended titration and maintenance dosage and recommended plasma arginine level testing during treatment. ( 2.2 ) • After eight weeks of once weekly intravenous LOARGYS, patients may be switched to once weekly subcutaneous LOARGYS at the same dosage of intravenous therapy. ( 2.4 ) • See Full Prescribing Information for dosage and administration modifications due to hypersensitivity reactions.

( 2.5 ) • See Full Prescribing Information for instructions on preparation, storage, and administration. ( 2.7 , 2.8 , 2.9 , 2.10 )

2.1Recommendations Prior to LOARGYS Treatment • Administer LOARGYS under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions ( 5.1 )] . • Initiate LOARGYS in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions ( 5.1 )] . • Obtain a baseline plasma arginine concentration. • Consider pre-medication with antihistamines [see Warnings and Precautions ( 5.1 )] .

2.2Recommended Dosage and Administration The recommended starting dosage of LOARGYS is 0.1 mg/kg administered via intravenous infusion once weekly [see Dosage and Administration ( 2.9 )] . For the recommended dosage use actual body weight. Recommended Adjustment, Maximum Dosage, and Monitoring To maximize the time within the normal range of 40 to 115 micromolar, dose adjustments should be aimed at achieving a pre-dose level of plasma arginine near the upper limit of normal (ULN).

After four weeks of LOARGYS administration, measure pre-dose plasma arginine (168 hours after prior dose) to determine the need for dosage adjustment. If two consecutive weekly pre-dose plasma arginine measurements are not in the desired therapeutic range, increase or decrease the weekly LOARGYS dosage as follows: • Below 50 micromolar, reduce the weekly LOARGYS dosage by 0.05 mg/kg. • Above 150 micromolar, increase the weekly LOARGYS dosage by 0.05 mg/kg. The maximum recommended LOARGYS dosage is 0.2 mg/kg once weekly.

Monitor plasma arginine levels (prior to LOARGYS dosing) weekly for 2 weeks after any LOARGYS dosage adjustment and as clinically indicated. Patients may be switched from intravenous administration of LOARGYS to subcutaneous administration [see Dosage and Administration ( 2.4 )] .

2.3Collect Plasma Arginine Using Specific Collection Tubes and Measure Arginine Concentration Using a Specific Assay Collect samples into Immedica Pharma’s Nor-NOHA Blood Collection Tubes, which contain Nω-hydroxy-nor-Arginine (nor-NOHA), an enzyme inhibitor used to inhibit post-sampling degradation of arginine by LOARGYS, and measure arginine concentration using Immedica Pharma’s LOARGYS Arginine Assay. LOARGYS is only available to a patient if the patient is enrolled in Study IMM-PEG-005 to obtain Immedica Pharma’s Nor-NOHA Blood Collection Tubes and LOARGYS Arginine Assay.

Further information is available by contacting Immedica Pharma at 1‑844‑627‑4687.

2.4Switching Patients from Intravenous to Subcutaneous LOARGYS Administration After eight weeks of once weekly intravenous LOARGYS, patients may be switched to once weekly subcutaneous LOARGYS at the same d… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 46 words ▾

3 DOSAGE FORMS AND STRENGTHS LOARGYS (pegzilarginase-nbln) is a clear to slightly opalescent, colorless to slightly yellow or slightly pink solution. Injection: 2 mg/0.4 mL or 5 mg/mL in a single-dose vial. Injection: 2 mg/0.4 mL and 5 mg/mL in a single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity : If a severe hypersensitivity reaction occurs, discontinue LOARGYS and immediately initiate appropriate medical treatment, including epinephrine. ( 5.1 )

5.1Hypersensitivity Reactions Including Anaphylaxis Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with enzyme replacement therapies (ERTs) including LOARGYS. Hypersensitivity reactions that were mild to moderate in severity occurred in 13% (6/48) of LOARGYS-treated patients in clinical trials [see Adverse Reactions ( 6 )] . Hypersensitivity reactions have included facial swelling, rash, flushing and dyspnea.

The reactions generally occurred with the first few doses, but may also occur later in treatment. LOARGYS-treated patients who developed anti-drug antibodies (ADA) generally had a greater incidence of hypersensitivity reactions compared to those who did not develop ADA [see Adverse Reactions ( 6.1 )] . Anaphylaxis has occurred during the early course of ERT and after extended duration of ERT.

Administration of LOARGYS should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. Consider pre‑medication with an antihistamine. Corticosteroids can be considered in patients who have previously developed a hypersensitivity reaction.

Initiate LOARGYS in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. • If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LOARGYS and immediately initiate appropriate medical treatment, including use of epinephrine. Consider the risks and benefits of re-administering LOARGYS following a severe hypersensitivity reaction (including anaphylaxis). Caution should be exercised upon rechallenge.

Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur. • If a mild or moderate hypersensitivity reaction occurs, consider treatment with antihistamines and/or corticosteroids. For intravenous administration, consider temporarily holding the infusion or slowing the infusion rate.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . Most common adverse reactions (>10%) are vomiting, pyrexia, infusion associated reactions and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Immedica at toll-free phone 1-844-627-4687 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LOARGYS was evaluated in a randomized, double-blind, placebo-controlled trial in pediatric and adult patients with ARG1-D (Trial 1). Additional safety information was derived from Trial 2, a Phase 1 open-label trial that evaluated 16 patients between the ages of 5 to 31 years to assess safety, PK and PD of LOARGYS, and Trial 3, an open-label extension including 14 patients from Trial 2.

Adverse Reactions from Trial 1 (Double-Blind Period) A total of 21 patients between the ages of 2 and 28 years of age, at enrollment, received intravenous LOARGYS dosages up to 0.2 mg/kg once weekly and 11 patients received placebo for 24 weeks [see Clinical Studies ( 14 )] . Table 1 summarizes the adverse reactions reported in ≥ 2 LOARGYS-treated patients and at a higher incidence in LOARGYS-treated patients compared to placebo-treated patients in Trial 1. Table 1: Common Adverse Reactions a in Pediatric and Adult Patients with ARG1-D in Trial 1 a Common adverse reactions were those that occurred in ≥ 2 LOARGYS-treated patients and at a higher incidence in LOARGYS-treated patients compared to placebo-treated patients. b Infusion-associated reactions are defined as reactions occurring within 4 hours after the infusion and included pruritus, arm swelling, and abdominal pain in LOARGYS-treated patients. c Includes reactions that were classified as hypersensitivity during the trial and reactions that were assessed as hypersensitivity based on symptoms and temporal relationship with drug.

Adverse Reaction LOARGYS N = 21 n (%) Placebo N = 11 n (%) Vomiting 7 (33) 3 (27) Pyrexia 4 (19) 1 (9) Infusion Associated Reaction b 3 (14) 1 (9) Constipation 3 (14) 1 (9) Dizziness 2 (10) 0 Fall 2 (10) 0 Hypersensitivity c 2 (10) 0 Nasopharyngitis 2 (10) 0 Rhinorrhoea 2 (10) 0 Alanine aminotransferase increased 2 (10) 0 Aspartate aminotransferase increased 2 (10) 0 Description of Selected Adverse Reactions Hypersensitivity Reactions : Hypersensitivity reactions with symptoms including facial swelling, rash, flushing and dyspnea were reported in 13% (6/48) of LOARGYS-treated patients during clinical trials [see Warnings and Precautions ( 5.1 )] .

Injection Site Reactions : Injection site reactions were reported in 14% (6/44) of patients after subcutaneous LOARGYS administration during the open-label extension periods in Trial 1 and Trial 3. Signs and symptoms included pain, erythema, swelling, irritation, and rash at the injection site. Immunogenicity: Anti-Drug Antibody-Associated Adverse Reactions Across Trials 1, 2, and 3, in patients with ARG1-D, the incidence of hypersensitivity reactions was 42% (5/12) in LOARGYS-treated patients who developed anti-drug antibodies (ADA) (i.e., anti-pegzilarginase-nbln antibodies and/or anti-PEG antibodies) and 3% (1/36) in those who were ADA-negative [see Clinical Pharmacology ( 12.6 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on LOARGYS use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of pegzilarginase-nbln to pregnant rats and rabbits during organogenesis resulted in maternal toxicity with associated increased incidence of fetal growth deficiencies (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study in pregnant rats with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered throughout organogenesis at 0.1, 0.3, and 1 mg/kg/dose on gestation days 6, 11, and 16.

Maternal toxicity was observed as reduced body weight, reduced body weight gain, reduced food consumption and reduced mean gravid uterine weights at 1 mg/kg/dose (8-fold the human exposure, based on AUC at the maximum recommended human dose (MRHD), with associated decreases in fetal body weights and increased fetal developmental malformations and variations at this dose. In an embryofetal development study in pregnant rabbits with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered throughout organogenesis at 0.06, 0.1, and 0.3 mg/kg/dose on gestation days 6, 13, and 20.

Maternal toxicity was observed as decreased maternal body weights, food consumption and mean gravid uterine weights at 0.3 mg/kg/dose (3-fold the human exposure, based on AUC at the MRHD), with associated decreases in fetal body weights and increased developmental malformations and variations at this dose. In a pre- and postnatal development study in pregnant rats with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered at 0.1, 0.3 and 1 mg/kg/dose once weekly from gestation day 6 to lactation day 20.

Maternal toxicity included reduced body weight and food consumption during gestation and lactation with associated reduced pup body weight at 1 mg/kg/dose (8-fold the human exposure based on AUC at the MRHD). Male pups exposed to 1 mg/kg/dose through gestation and lactation also had impaired learning and memory in the passive avoidance test.

8.2Lactation Risk Summary There are no data on the presence of pegzilarginase-nbln in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LOARGYS and any potential adverse effects on the breast-fed infant from LOARGYS or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of LOARGYS have been established under accelerated approval for the treatment of hyperargininemia in pediatric patients 2 years of age and older with ARG1-D, in conjunction with dietary protein restriction [see Indications and Usage ( 1 )] . Use of LOARGYS for this indication is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients that included 29 pediatric patients 2 to 17 years of age with ARG1-D (Trial 1) and additional safety information from an open-label extension trial in adult and pediatric patients that included 9 pediatric patients (Trial 3) [see Adverse Reactions ( 6.1 )] .

The safety and effectiveness of LOARGYS have not been established for the treatment of hyperargininemia in pediatric patients less than 2 years of age with ARG1-D. Juvenile Animal Toxicity Data Juvenile rats with normal circulating arginine levels were administered once weekly intravenous pegzi… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on LOARGYS use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of pegzilarginase-nbln to pregnant rats and rabbits during organogenesis resulted in maternal toxicity with associated increased incidence of fetal growth deficiencies (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal development study in pregnant rats with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered throughout organogenesis at 0.1, 0.3, and 1 mg/kg/dose on gestation days 6, 11, and 16.

Maternal toxicity was observed as reduced body weight, reduced body weight gain, reduced food consumption and reduced mean gravid uterine weights at 1 mg/kg/dose (8-fold the human exposure, based on AUC at the maximum recommended human dose (MRHD), with associated decreases in fetal body weights and increased fetal developmental malformations and variations at this dose. In an embryofetal development study in pregnant rabbits with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered throughout organogenesis at 0.06, 0.1, and 0.3 mg/kg/dose on gestation days 6, 13, and 20.

Maternal toxicity was observed as decreased maternal body weights, food consumption and mean gravid uterine weights at 0.3 mg/kg/dose (3-fold the human exposure, based on AUC at the MRHD), with associated decreases in fetal body weights and increased developmental malformations and variations at this dose. In a pre- and postnatal development study in pregnant rats with normal circulating arginine levels, intravenous pegzilarginase-nbln was administered at 0.1, 0.3 and 1 mg/kg/dose once weekly from gestation day 6 to lactation day 20.

Maternal toxicity included reduced body weight and food consumption during gestation and lactation with associated reduced pup body weight at 1 mg/kg/dose (8-fold the human exposure based on AUC at the MRHD). Male pups exposed to 1 mg/kg/dose through gestation and lactation also had impaired learning and memory in the passive avoidance test.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of LOARGYS have been established under accelerated approval for the treatment of hyperargininemia in pediatric patients 2 years of age and older with ARG1-D, in conjunction with dietary protein restriction [see Indications and Usage ( 1 )] . Use of LOARGYS for this indication is supported by evidence from an adequate and well-controlled trial in adult and pediatric patients that included 29 pediatric patients 2 to 17 years of age with ARG1-D (Trial 1) and additional safety information from an open-label extension trial in adult and pediatric patients that included 9 pediatric patients (Trial 3) [see Adverse Reactions ( 6.1 )] .

The safety and effectiveness of LOARGYS have not been established for the treatment of hyperargininemia in pediatric patients less than 2 years of age with ARG1-D. Juvenile Animal Toxicity Data Juvenile rats with normal circulating arginine levels were administered once weekly intravenous pegzilarginase-nbln doses of 0.1, 0.3 and 1 mg/kg/dose from postnatal day 21 (the equivalent of a 2-year-old human) up to 13 weeks of age. At 1 mg/kg (15-fold the human exposure based on AUC at the MRHD), male and female rats showed increased incidence of tremors, salivation, and piloerection, along with reduced body weight and body weight gain.

Reproductive organ effects were observed in male rats administered 1 mg/kg, including decreased sperm motility and total sperm count, increased percentage of abnormal sperm, and decreased epididymis, testes and prostate gland weights.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of LOARGYS did not include patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ARG1-D is an inherited metabolic disease characterized by deficiency of the arginase 1 enzyme and associated with the persistent elevation of plasma arginine. LOARGYS provides an exogenous source of the deficient human arginase 1 enzyme activity in patients with ARG1-D and reduces plasma arginine by converting it to urea and ornithine.

12.2Pharmacodynamics Treatment with intravenous LOARGYS in patients with ARG1-D led to dose-dependent reduction in plasma arginine levels with median time to nadir (lowest arginine level) of 2‑5 hours. After once weekly intravenous administration at the recommended dosage, plasma arginine levels reached steady state on or before Week 8 (see Figure 1 ) . Predose plasma arginine levels were similar after switching from intravenous to subcutaneous LOARGYS administration at the same dose.

For a given dose level, the nadir following subcutaneous dosing was higher and led to shorter durations of LOARGYS-induced hypoargininemia. Treatment with intravenous or subcutaneous LOARGYS in patients with ARG1-D led to increases in plasma ornithine levels and decreases in plasma levels of the guanidino compounds argininic acid, guanidinoacetic acid, α-k-δ-guanidinovaleric acid, and Nα-acetyl-L-arginine.

12.3Pharmacokinetics The maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) of pegzilarginase-nbln at steady state following intravenous and subcutaneous administration of LOARGYS at the 0.1 mg/kg weekly dosage in adults and pediatric patients with ARG1‑D are summarized in Table 2 . Pegzilarginase-nbln exposures increased in an approximately dose-proportional manner at the recommended dosages. Table 2: Pharmacokinetic Parameters of Pegzilarginase-nbln at Steady State in Adult and Pediatric Patients with ARG1-D Abbreviations: AUC 0-168 =area under the concentration-time curve from time 0 to 168 hours; C max =maximum concentration * Data displayed are geometric mean and geometric coefficient of variation (%) Intravenous LOARGYS Subcutaneous LOARGYS [C max (µg/mL)]* 2.48 (20%) 0.58 (20%) [AUC 0‑168 (h*µg/mL)]* 108 (18%) 61.3 (18%) Absorption Following subcutaneous LOARGYS administration, the mean absolute bioavailability was 57% and the median time to reach maximum concentration (T max ) was approximately 34 hours.

Distribution The volume of distribution of pegzilarginase-nbln was approximately 47 mL/kg. Elimination Pegzilarginase-nbln clearance (CL) was 0.029 L/h. The mean half-life was approximately 50 hours.

Metabolism Pegzilarginase-nbln is expected to be metabolized into small peptides and amino acids by catabolic pathways. Specific Populations Age and sex did not have clinically meaningful effect on the pharmacokinetics of pegzilarginase-nbln once the effect of body weight was taken into account.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADAs) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADAs in the trials described below with the incidence of ADA in other studies, including those of LOARGYS or of other pegzilarginase products. The incidence of ADAs (i.e., anti-pegzilarginase-nbln antibodies and/or anti-PEG antibodies) in LOARGYS-treated pediatric and adult patients with ARG1-D over 6 to 274 weeks in Trials 1, 2, and 3 is summarized in Table 3 . • In Trial 2, anti-PEG antibodies were observed after the second LOARGYS dose and peak anti-PEG antibody titers occurred at Week 3.

In Trial 1, peak anti-PEG antibody titers were observed at Week 7. • Anti-pegzilarginase-nbln antibodies showed similar titer profiles as anti-PEG antibodies in Trial 2, while no obvious peak titer was observed in Trial 1. • The anti-pegzilarginase-nbln antibody and anti-PEG antibody titers decreased during continued LOARGYS treatment with the median duration of ADA positivity lasting approximately two weeks. The inc… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 55 words ▾

12.1Mechanism of Action ARG1-D is an inherited metabolic disease characterized by deficiency of the arginase 1 enzyme and associated with the persistent elevation of plasma arginine. LOARGYS provides an exogenous source of the deficient human arginase 1 enzyme activity in patients with ARG1-D and reduces plasma arginine by converting it to urea and ornithine.

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LOARGYS (pegzilarginase-nbln) is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellow or slightly pink solution. LOARGYS is available as: • One single-dose vial 2 mg/0.4 mL in a carton (NDC 81583-102-01) • One single-dose vial 5 mg/mL in a carton (NDC 81583-105-01). Storage and Handling Store refrigerated at 2 °C to 8 °C (36 °F to 46 °F) in the original carton to protect from light.

Do not freeze. Do not shake.

📋 Description 134 words ▾

11 DESCRIPTION Pegzilarginase-nbln is a trimeric cobalt substituted recombinant human arginase 1 enzyme conjugated with six to twelve moles of 5 kDa monomethoxy polyethylene glycol (mPEG) per monomer. The molecular weight of pegzilarginase-nbln is approximately 224 to 344 kDa. LOARGYS (pegzilarginase-nbln) injection is a sterile, preservative-free, clear to slightly opalescent, and colorless to slightly yellow or slightly pink solution in a single-dose vial for intravenous infusion or subcutaneous injection.

Available as 2 mg of pegzilarginase-nbln in 0.4 mL or 5 mg of pegzilarginase-nbln in 1 mL. Each 1 mL contains 5 mg pegzilarginase-nbln, dibasic potassium phosphate (0.7 mg), glycerin (15 mg), monobasic potassium phosphate (0.14 mg), sodium chloride (2.92 mg), Water for Injection, USP, and hydrochloric acid and/ or sodium hydroxide to adjust pH to 7 to

7.6The resultant concentration is 5 mg/mL.

💬 Information for Patients 79 words ▾

17 PATIENT COUNSELING INFORMATION Hypersensitivity Reactions Including Anaphylaxis : Advise the patient and caregiver that life-threatening hypersensitivity reactions, including anaphylaxis may occur with LOARGYS treatment. Advise the patient or caregiver that anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Inform the patient and caregiver of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis, and to seek immediate medical care should symptoms occur [see Warnings and Precautions ( 5.1 )] .

🧬 Pharmacokinetics 217 words ▾

12.3Pharmacokinetics The maximum plasma concentration (C max ) and area under the plasma concentration-time curve (AUC) of pegzilarginase-nbln at steady state following intravenous and subcutaneous administration of LOARGYS at the 0.1 mg/kg weekly dosage in adults and pediatric patients with ARG1‑D are summarized in Table 2 . Pegzilarginase-nbln exposures increased in an approximately dose-proportional manner at the recommended dosages. Table 2: Pharmacokinetic Parameters of Pegzilarginase-nbln at Steady State in Adult and Pediatric Patients with ARG1-D Abbreviations: AUC 0-168 =area under the concentration-time curve from time 0 to 168 hours; C max =maximum concentration * Data displayed are geometric mean and geometric coefficient of variation (%) Intravenous LOARGYS Subcutaneous LOARGYS [C max (µg/mL)]* 2.48 (20%) 0.58 (20%) [AUC 0‑168 (h*µg/mL)]* 108 (18%) 61.3 (18%) Absorption Following subcutaneous LOARGYS administration, the mean absolute bioavailability was 57% and the median time to reach maximum concentration (T max ) was approximately 34 hours.

Distribution The volume of distribution of pegzilarginase-nbln was approximately 47 mL/kg. Elimination Pegzilarginase-nbln clearance (CL) was 0.029 L/h. The mean half-life was approximately 50 hours.

Metabolism Pegzilarginase-nbln is expected to be metabolized into small peptides and amino acids by catabolic pathways. Specific Populations Age and sex did not have clinically meaningful effect on the pharmacokinetics of pegzilarginase-nbln once the effect of body weight was taken into account.

🧬 Pharmacodynamics 126 words ▾

12.2Pharmacodynamics Treatment with intravenous LOARGYS in patients with ARG1-D led to dose-dependent reduction in plasma arginine levels with median time to nadir (lowest arginine level) of 2‑5 hours. After once weekly intravenous administration at the recommended dosage, plasma arginine levels reached steady state on or before Week 8 (see Figure 1 ) . Predose plasma arginine levels were similar after switching from intravenous to subcutaneous LOARGYS administration at the same dose.

For a given dose level, the nadir following subcutaneous dosing was higher and led to shorter durations of LOARGYS-induced hypoargininemia. Treatment with intravenous or subcutaneous LOARGYS in patients with ARG1-D led to increases in plasma ornithine levels and decreases in plasma levels of the guanidino compounds argininic acid, guanidinoacetic acid, α-k-δ-guanidinovaleric acid, and Nα-acetyl-L-arginine.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of LOARGYS for the treatment of hyperargininemia in adult and pediatric patients with ARG1-D was evaluated in Trial 1 (NCT03921541) which was a multicenter, double-blind, 24-week placebo-controlled trial with a long-term open-label extension period of up to 150 weeks. A total of 32 patients were randomized 2:1 to receive intravenous LOARGYS (n=21) or placebo (n=11) once weekly for 24 weeks. Of the 32 patients randomized in Trial 1, 19 were males (59%) and 13 were females (41%).

Patients were between 2 to 29 years of age with 90% of patients between 2 to 17 years of age (median pediatric age was 9 years) at enrollment. The patient population consisted of 14 Whites (44%), 6 Asians (19%), 2 Black or African Americans (6%), and 2 in mixed racial groups (6%). Ethnicity consisted of 9 patients who were Hispanic or Latino (28%) and 23 who were Not Hispanic or Latino (72%).

LOARGYS-treated patients received an initial dosage of 0.1 mg/kg and were titrated within a range of 0.05 mg to 0.2 mg/kg, as clinically indicated. Patients who previously had an ARG1-D-related dietary regimen or ammonia scavengers continued to receive these treatment(s) throughout the initial trial period. A total of 31 patients completed the double-blind period; one patient in the LOARGYS arm discontinued for personal reasons.

The primary endpoint in Trial 1 was the change from baseline in plasma arginine at Week 24. LOARGYS-treated patients had a significant mean reduction in plasma arginine levels from baseline to Week 24 ( Table 4 ). Additionally, 90% of LOARGYS-treated patients achieved target plasma arginine levels (below 200 μM) and normalized levels, compared to 0% of placebo-treated patients.

Figure 1 displays the mean plasma arginine levels over time by the randomized treatment group. Table 4: Change in Plasma Arginine (micromolar) from Baseline at Week 24 in Patients with ARG1-D, Trial 1 Study Visit LOARGYS Placebo 1 Calculated as the average of at most four measurements from Week 21 through Week 24. 2 The treatment difference in least-square means was estimated by a mixed model for repeated measures including treatment, visit, treatment-by-visit interaction, and baseline arginine value.

The p-value for testing the treatment difference is <0.0001. Baseline N = 21 N = 11 Mean (SD) 365 (94) 472 (80) Week 24 1 N = 20 N = 11 Mean (SD) 92 (51) 449 (86) Mean Absolute Change at Week 24 (SD) -272 (104) -23 (99) Treatment Difference (95% CI) 2 -312 (-384, -239) Mean Percent Change at Week 24 (%) (SD) -74 (14) -3 (20) Treatment Difference (95% CI) 2 -72 (-89, -55) All 31 patients (n=20 LOARGYS and n=11 placebo) who completed the double-blind period entered the extension period and received open label treatment of LOARGYS: • First 8 weeks: Patients who were previously treated with intravenous LOARGYS continued their weekly intravenous LOARGYS dosage and patients who were previously treated with placebo initially received 0.1 mg/kg of weekly intravenous LOARGYS.

The LOARGYS dosage in both groups could be modified based on plasma arginine levels. • After the first 8 weeks: Patients had the option to receive weekly subcutaneous LOARGYS (same as the intravenous dosage) that could be modified based on plasma arginine levels up to a maximum of 0.2 mg/kg weekly. The median duration of LOARGYS exposure in the extension period, excluding the double-blind period of 24 weeks, was 94 weeks (range: 62 to 152 weeks). During the extension period, patients who switched from placebo to LOARGYS achieved similar reductions in mean plasma arginine levels as those who had received LOARGYS from the start of the study ( Figure 1 ).

Figure 1: Mean (95% CI) Plasma Arginine Level (micromolar) in Patients with ARG1-D By Visit (Weeks), Trial 1 Notes: 95% confidence interval of mean (pre-dose) is displayed; Recommended plasma arginine levels: below 200 micromolar; Normal range defined as 40–115 micromolar in Trial 1. The x-axis unit of time is visit week.… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential have not been performed with LOARGYS. Mutagenesis Studies to evaluate the mutagenic potential of LOARGYS have not been conducted. Impairment of Fertility In a fertility and early embryonic development study in rats with normal circulating arginine levels, pegzilarginase-nbln was administered intravenously at 0.1, 0.3 and 1 mg/kg/dose once weekly to males 56 days prior to mating and continuing through mating, and to females 14 days prior to mating and continuing through gestation day 7.

Male rats administered 1 mg/kg/dose (0.8-fold the MRHD, based on body surface area) showed increased salivation, thin body condition and unkempt appearance, reduced body weights, reduced food consumption, decreased sperm motility, decreased sperm concentration and increased abnormal sperm morphology, which was associated with decreased uterine implantation sites and increased pre-implantation loss in untreated paired females. Female rats administered 1 mg/kg/dose (0.8-fold the MRHD, based on body surface area) showed reduced body weight, and decreased fecundity and fertility indices when paired with untreated males.

13.2Animal Toxicology and/or Pharmacology In a repeated dose toxicity study in rats with normal circulating arginine levels, pegzilarginase-nbln was administered intravenously at 0.1, 0.3, and 1 mg/kg once weekly for 6 months beginning on postnatal day 21. Decreased body weight gain, and increased convulsions, tremors, salivation, and piloerection were observed in males and females at 1 mg/kg/dose (15-fold the human exposure based on AUC at the MRHD). In male rats administered doses ≥0.3 mg/kg (4.5-fold the human exposure based on AUC at the MRHD), findings included decreased reproductive organ weights (testis, seminal vesicles, epididymis and prostate), testicular tubular degeneration, epididymal germ cell debris, and decreased sperm motility, decreased total sperm count and increased percentage of abnormal sperm.

In a repeated dose toxicity study in monkeys with normal circulating arginine levels, pegzilarginase-nbln was administered intravenously at 0.1, 0.3 and 1 mg/kg/dose once weekly for 13 weeks. Decreased body weight, inappetence, hunched posture and watery feces led to early death of two males administered 1 mg/kg (11-fold the human exposure based on AUC at the MRHD). Tremor and decreased activity were also observed in these animals.

Surviving male and female monkeys administered doses of 1 mg/kg showed reduced body weight, increased incidences of sparse hair, tremors, inappetence, and decreased activity. Animals were considered immature during dose administration therefore effects on reproductive organs could not be assessed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 172 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential have not been performed with LOARGYS. Mutagenesis Studies to evaluate the mutagenic potential of LOARGYS have not been conducted. Impairment of Fertility In a fertility and early embryonic development study in rats with normal circulating arginine levels, pegzilarginase-nbln was administered intravenously at 0.1, 0.3 and 1 mg/kg/dose once weekly to males 56 days prior to mating and continuing through mating, and to females 14 days prior to mating and continuing through gestation day 7.

Male rats administered 1 mg/kg/dose (0.8-fold the MRHD, based on body surface area) showed increased salivation, thin body condition and unkempt appearance, reduced body weights, reduced food consumption, decreased sperm motility, decreased sperm concentration and increased abnormal sperm morphology, which was associated with decreased uterine implantation sites and increased pre-implantation loss in untreated paired females. Female rats administered 1 mg/kg/dose (0.8-fold the MRHD, based on body surface area) showed reduced body weight, and decreased fecundity and fertility indices when paired with untreated males.

📄 Package Label / Principal Display Panel 97 words ▾

PRINCIPAL DISPLAY PANEL - 2 mg/0.4 mL Carton Carton Label 2 mg/0.4 mL NDC: 81583-102-01 Rx only Loargys (pegzilarginase-nbln) Injection 2 mg/0.4 mL For Intravenous Infusion After Dilution or Subcutaneous Injection One 0.4 mL single-dose vial discard unused portion Immedica pharma Principal Display Panel - 2 mg/0.4 mL Carton

PRINCIPAL DISPLAY PANEL - 5 mg/1 mL Carton Carton Label 5 mg/1 mL NDC: 81583-105-01 Rx only Loargys (pegzilarginase-nbln) Injection 5 mg/mL For Intravenous Infusion After Dilution or Subcutaneous Injection One 1 mL single-dose vial Discard unused portion Immedica pharma Principal Display Panel - 5 mg/1 mL Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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← 81583-0100-01 · Immedica
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