Pegvaliase
| Clinical data | |
|---|---|
| Pronunciation | peg val' i ase |
| Trade names | Palynziq |
| Other names | Pegvaliase-pqpz; PEG-PAL; RAvPAL-PEG |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618057 |
| License data |
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| Pregnancy category | |
| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C10872H17216N3040O3300S80[6][7] |
| Molar mass | 245880.10 g·mol−1 |
Pegvaliase, sold under the brand name Palynziq, is a medication used for the treatment of the genetic disease phenylketonuria (PKU).[4][8][9] It is a phenylalanine (Phe)‑metabolizing enzyme.[4] Chemically, it is a pegylated derivative of the enzyme phenylalanine ammonia-lyase that metabolizes phenylalanine to reduce its blood levels.[4]
The most common adverse events include injection site reactions, joint pain, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, pruritus (itchy skin), nausea, dizziness, abdominal pain, throat pain, fatigue, vomiting, cough and, diarrhea.[8]
It was approved by the US Food and Drug Administration (FDA) for use in the United States in 2018.[8] The FDA considers it to be a first-in-class medication.[10]
- ^ a b "Palynziq". Therapeutic Goods Administration (TGA). 23 July 2021. Archived from the original on 5 September 2021. Retrieved 5 September 2021.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
- ^ "Palynziq Product information". Health Canada. 25 April 2012. Archived from the original on 29 June 2022. Retrieved 29 June 2022.
- ^ a b c d "Palynziq- pegvaliase-pqpz injection, solution". DailyMed. 21 December 2022. Retrieved 12 December 2023.
- ^ "Palynziq EPAR". European Medicines Agency. 28 January 2010. Retrieved 22 May 2024.
- ^ "Pegvaliase". Inxight Drugs. Retrieved 22 May 2024.
- ^ "Pegvaliase". GSRS. Retrieved 22 May 2024.
- ^ a b c "FDA approves a new treatment for PKU, a rare and serious genetic disease" (Press release). U.S. Food and Drug Administration (FDA). 24 May 2018. Archived from the original on 25 July 2021. Retrieved 12 October 2020. This article incorporates text from this source, which is in the public domain.
- ^ Mahan KC, Gandhi MA, Anand S (April 2019). "Pegvaliase: a novel treatment option for adults with phenylketonuria". Current Medical Research and Opinion. 35 (4): 647–651. doi:10.1080/03007995.2018.1528215. PMID 30247930. S2CID 52813510.
- ^ New Drug Therapy Approvals 2018. U.S. Food and Drug Administration (FDA) (Report). January 2019. Archived from the original (PDF) on 17 September 2020. Retrieved 16 September 2020.