Statements (76)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmaceutical drug
|
| gptkbp:activeDuring |
pegvaliase
|
| gptkbp:clinicalTrials |
Phase 3
long-term treatment NCT02720012 NCT02720025 |
| gptkbp:contraindication |
anemia
anxiety depression dizziness fatigue headache nausea sleep disturbances hypertension weight loss fever vomiting rash dry skin insomnia chills numbness sweating hypoglycemia thrombocytopenia tremors increased heart rate hypotension palpitations muscle cramps edema thirst mood changes hyperglycemia skin changes flushing tingling increased blood pressure neutropenia cognitive changes vision changes increased liver enzymes arthralgia myalgia hearing changes hypersensitivity_to_pegvaliase pruritus |
| gptkbp:date |
2018-05-24
|
| gptkbp:dosageForm |
injection
|
| gptkbp:drugInterdiction |
true
subcutaneous absorption none significant reported reduces phenylalanine levels |
| gptkbp:embodiment |
yes
|
| gptkbp:formulation |
solution
|
| gptkbp:hasPopulation |
adults_with_PKU
|
| https://www.w3.org/2000/01/rdf-schema#label |
Palynziq
|
| gptkbp:label |
Palynziq (pegvaliase-pqpz)
|
| gptkbp:mandates |
chronic_management_of_adult_patients_with_PKU
|
| gptkbp:manufacturer |
gptkb:BioMarin_Pharmaceutical
|
| gptkbp:marketSegment |
available
|
| gptkbp:name |
not on WHO Essential Medicines List
|
| gptkbp:offers |
varies by region
|
| gptkbp:packaging |
single-dose prefilled syringe
|
| gptkbp:patentStatus |
patented
|
| gptkbp:patentType |
yes
|
| gptkbp:researchAreas |
ongoing studies
|
| gptkbp:route |
subcutaneous injection
|
| gptkbp:shelfLife |
24 months
|
| gptkbp:sideEffect |
allergic reactions
injection site reactions gastrointestinal disorders |
| gptkbp:storage |
refrigerated
|
| gptkbp:triggerType |
enzyme substitution therapy
|
| gptkbp:usedFor |
treatment of phenylketonuria (PKU)
|