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LOARGYS (PEGZILARGINASE-NBLN)
LOARGYS (generic name: PEGZILARGINASE-NBLN) is a drug developed by IMMEDICA PHARMA AB. It is currently FDA-approved.
At a glance
| Generic name | PEGZILARGINASE-NBLN |
|---|---|
| Sponsor | IMMEDICA PHARMA AB |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- 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 )
Common side effects
- Vomiting
- Pyrexia
- Infusion Associated Reaction
- Constipation
- Dizziness
- Fall
- Hypersensitivity
- Nasopharyngitis
- Rhinorrhoea
- Alanine aminotransferase increased
- Aspartate aminotransferase increased
- Injection Site Reactions
Serious adverse events
- Hypersensitivity Reactions (in ADA-positive patients)
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LOARGYS CI brief — competitive landscape report
- LOARGYS updates RSS · CI watch RSS
- IMMEDICA PHARMA AB portfolio CI
Frequently asked questions about LOARGYS
What is LOARGYS?
LOARGYS (PEGZILARGINASE-NBLN) is a pharmaceutical drug developed by IMMEDICA PHARMA AB.
Who makes LOARGYS?
LOARGYS is developed and marketed by IMMEDICA PHARMA AB (see full IMMEDICA PHARMA AB pipeline at /company/immedica-pharma-ab).
What is the generic name of LOARGYS?
PEGZILARGINASE-NBLN is the generic (nonproprietary) name of LOARGYS.
What development phase is LOARGYS in?
LOARGYS is FDA-approved (marketed).
What are the side effects of LOARGYS?
Common side effects of LOARGYS include Vomiting, Pyrexia, Infusion Associated Reaction, Constipation, Dizziness, Fall. Serious adverse events: Hypersensitivity Reactions (in ADA-positive patients).
Related
- Manufacturer: IMMEDICA PHARMA AB — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing