Overview
Indications
Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.
Boxed Warning
FDA Black Box Warning
5.1 [see Warnings and Precautions ()] Anaphylaxis has been reported after administration of Palynziq and may occur at any time during treatment. 2.4 [see Dosage and Administration ()] Administer the initial dose of Palynziq under the supervision of a healthcare provider equipped to manage anaphylaxi
Contraindications
When this intervention should not be used
None.
Indications & Related Conditions
Conditions associated via SNOMED clinical relationships
Administration & Protocol
Dosing, route, and treatment protocol
Detailed dosage and administration information is available in the full FDA drug label.
View full prescribing information on DailyMedMonitoring & Follow-Up
Biomarkers relevant to this intervention via related conditions
No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.
Clinical Trials
10 trials linked to this intervention
Recent Trials
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period
Effects of Kuvan on Melatonin Secretion
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria
The Effectiveness of Kuvan in Amish PKU Patients
Phenylalanine and Its Impact on Cognition
Research Evidence
Published studies and systematic reviews
Research data from MEDLINE/PubMed
Benefits & Expected Outcomes
Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.
Risks & Side Effects
Adverse reaction and safety data for this drug is sourced from the FDA-approved label.
View adverse reactions & drug interactions on DailyMedRelated Symptoms
Symptoms associated with conditions this intervention addresses
No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.
Alternatives & Comparisons
Alternative treatments, comparison data, and clinical decision support are pending physician authorship.
This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.
Do not start, stop, or change any treatment without consulting your healthcare provider.
Quick Facts
- Type
- Substance / Medication
- Fully Specified Name
- Pegvaliase (substance)
- SNOMED CT
- 770965008
- UMLS CUI
- C4519229
- RxNorm CUI
- 2046360
- Labeler
- BioMarin Pharmaceutical Inc.
Clinical Data
This intervention maps to 1 entities in the Ltrl knowledge graph.
Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.