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Palynziq Generic Name & Formulations
Legal Class
Rx
General Description
Pegvaliase-pqpz 2.5mg/0.5mL, 10mg/0.5mL, 20mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Phenylalanine-metabolizing enzyme.
How Supplied
Prefilled syringes (2.5mg/0.5mL, 10mg/0.5mL)—1; (20mg/mL)—1, 10
Manufacturer
Generic Availability
NO
Palynziq Indications
Indications
To reduce blood phenylalanine levels in adults with phenylketonuria (PKU) who have uncontrolled concentrations >600μmol/L on current management.
Palynziq Dosage and Administration
Adult
Consider premedication with H1- or H2-receptor antagonist, and/or antipyretic prior to administration. Give by SC inj into the front middle of thighs, abdomen, top of buttocks, back of upper arms; rotate inj sites. Inject ≥2 inches apart if >1 inj required. Induction: initially 2.5mg once weekly for 4 weeks. Titration: in a step-wise manner, titrate over ≥5 weeks to achieve 20mg once daily, as tolerated; see full labeling. Maintenance: 20mg once daily for ≥24 weeks. Consider increasing to 40mg once daily if maintained continuously on 20mg once daily for ≥24 weeks without achieving control (blood phenylalanine ≤600μmol/L). Consider increasing to max 60mg once daily if maintained continuously on 40mg once daily for ≥16 weeks without achieving control. Discontinue if no response after 16 weeks of treatment at max 60mg dose. Dosing reduction, readministration: see full labeling.
Children
Not established.
Palynziq Contraindications
Not Applicable
Palynziq Boxed Warnings
Boxed Warning
Risk of anaphylaxis.
Palynziq Warnings/Precautions
Warnings/Precautions
Anaphylaxis may occur during treatment. Have epinephrine readily available. Perform 1st initial dose and/or readministration after anaphylaxis under supervision of a healthcare provider (consider having an adult observer as needed during therapy); monitor closely for ≥60mins post injection. Dose adjustment, interruption, or treatment with antihistamines, antipyretics, and/or corticosteroids to manage hypersensitivity reactions. Obtain baseline blood phenylalanine concentration prior to therapy, every 4 weeks until maintenance dose established, then periodically thereafter. Assess dietary protein and phenylalanine intake throughout treatment. Do not inj into moles, scars, birthmarks, bruises, rashes, or areas where skin is hard, tender, red, damaged, burned, inflamed, tattooed. Use lowest effective dose. Pregnancy: monitor and maintain phenylalanine levels 120–360μmol/L for 3 months prior to and during pregnancy; adjust dose or dietary intake to avoid <30μmol/L. Nursing mothers: monitor.
REMS
Palynziq Pharmacokinetics
See Literature
Palynziq Interactions
Interactions
Concomitant other PEGylated products; monitor for hypersensitivity reactions.
Palynziq Adverse Reactions
Adverse Reactions
Inj site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions (lasting ≥14 days), nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, anxiety; anaphylaxis.
Palynziq Clinical Trials
See Literature
Palynziq Note
Notes
Report Palynziq exposure in pregnant patients by calling (866) 906-6100.
Palynziq Patient Counseling
See Literature
