loargys
Loargys (Pegzilarginase-Nbln) is a medication used to treat Hyperargininemia.
Pegzilarginase-Nbln · by Immedica Pharma Ab
Key facts
- Active ingredient
- Pegzilarginase-Nbln
- Form
- Injectable
- Strength
- PEGZILARGINASE-NBLN 0.1MG/KG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- hyperargininemia
- Manufacturer
- Immedica Pharma Ab
- FDA application
- BLA761211
- FDA boxed warning
- Yes — see the boxed warning
What is Loargys?
From the FDA label: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 7.6 The resultant concentration is 5 mg/mL.
How to use
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…
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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 )
Warnings
Important safety information
Hypersensitivity : If a severe hypersensitivity reaction occurs, discontinue LOARGYS and immediately initiate appropriate medical treatment, including epinephrine. ( 5.1 ) 5.1 Hypersensitivity 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.
Who should not take Loargys
None. None. ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Loargys treat?
- Loargys (Pegzilarginase-Nbln) may be used to treat hyperargininemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Loargys?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Loargys. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Loargys?
- Loargys is marketed by Immedica Pharma Ab. You can see Immedica Pharma Ab's full profile, rating, and other products on pharmaranks.
- Is Loargys a brand-name or generic drug?
- Loargys is a brand-name product with the active ingredient Pegzilarginase-Nbln.
- Is Loargys available over the counter?
- No. Loargys is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Loargys come in?
- Loargys is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Loargys FDA-registered?
- Loargys is on record with the U.S. FDA under application number BLA761211. You can verify this on its official FDA label.
- Is Loargys safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Loargys. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Loargys?
- Loargys's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
abiraterone acetate
Abiraterone Acetate
acular
Ketorolac Tromethamine
acular ls
Ketorolac Tromethamine
aimovig
Erenumab-Aooe
albendazole
Albendazole
alphagan p
Brimonidine Tartrate
Compare Loargys head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
loargys
New