Loargys 2 mg/.4mL
pegzilarginase-nbln · INJECTION · Immedica Pharma US Inc.
Loargys is a injection containing pegzilarginase-nbln at 2 mg/.4mL, taken intravenous. Manufactured by Immedica Pharma US Inc..
Key Facts
- Brand Name
- Loargys
- Generic Name
- pegzilarginase-nbln
- NDC Code (Product)
81583-102- Manufacturer
- Immedica Pharma US Inc.
- Strength
- 2 mg/.4mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761211
- Marketing Start
- 03/09/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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, sto…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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. 6.1 Clinical 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 patie…
Frequently Asked Questions
What is Loargys used for?
Loargys contains pegzilarginase-nbln. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Loargys a controlled substance?
Loargys is not classified as a controlled substance by the DEA.
What is the generic name for Loargys?
The generic name for Loargys is pegzilarginase-nbln. There are no other listed brand versions of pegzilarginase-nbln.
What is the NDC code for Loargys 2 mg/.4mL?
The NDC (National Drug Code) for Loargys 2 mg/.4mL is 81583-102, listed by Immedica Pharma US Inc..
Other Loargys Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)