Pegzilarginase-Nbln: uses, dosing, side effects & brands
Pegzilarginase-Nbln is a medicine sold in the U.S. under one brand, for hyperargininemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Hyperargininemia
- Available as
- Injectable
- Sold as
- Loargys
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How pegzilarginase-nbln is dosed
From the FDA label for Loargys (application BLA761211). Other pegzilarginase-nbln products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ) 2.1 Recommendations Prior to LOARGYS Treatment • Administer LOARGYS under the supervision of a healthcare provider knowledgeable in the management of hypersensitivity reactions…
Pegzilarginase-Nbln side effects
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 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…
Who shouldn’t take pegzilarginase-nbln
None. None. ( 4 )
Every pegzilarginase-nbln product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Loargys.
Related calculators
Frequently asked questions
What is pegzilarginase-nbln?
Loargys (Pegzilarginase-Nbln) is a medication used to treat Hyperargininemia.
Can you take pegzilarginase-nbln with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pegzilarginase-nbln against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pegzilarginase-nbln come in?
Across the brands we track, pegzilarginase-nbln is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pegzilarginase-nbln?
We do not currently list a generic-labelled pegzilarginase-nbln product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pegzilarginase-Nbln: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pegzilarginase-nbln
- MLA
- “Pegzilarginase-Nbln: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pegzilarginase-nbln.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pegzilarginase-nbln on DailyMed (NIH) ↗ — including its boxed warning in full.