Generic Name and Formulations:
Pegvaliase-pqpz 2.5mg/0.5mL, 10mg/0.5mL, 20mg/mL; soln for SC inj; preservative-free.
RECENT UPDATESMonograph added.
Indications for PALYNZIQ:
To reduce blood phenylalanine levels in adults with phenylketonuria (PKU) who have uncontrolled concentrations >600μmol/L on current management.
See full labeling. 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 max 40mg once daily if maintained continuously on 20mg once daily for ≥24 weeks and have not achieved ≥20% reduction from pre-treatment baseline or a concentration ≤600μmol/L; discontinue if no response after 16 weeks of treatment at 40mg dose.
Risk of anaphylaxis.
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.
Concomitant other PEGylated products; monitor for hypersensitivity reactions.
Inj site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions (lasting ≥14 days), pruritus, nausea, abdominal pain, oropharyngeal pain, vomiting, cough, diarrhea, fatigue; anaphylaxis.
Report Palynziq exposure in pregnant patients by calling (866) 906-6100.
Prefilled syringes (2.5mg/0.5mL, 10mg/0.5mL)—1; (20mg/mL)—1, 10
Sign Up for Free e-newsletters
Psychiatry Advisor Articles
- Distinct Characteristics in Children at Risk for Schizophrenia vs Bipolar Disorder
- Nonstimulants May Be an Appropriate Alternative to Stimulants for Treating ADHD
- Psychotic Experiences Associated With Increased Risk for Eating Disorders in Adolescents
- Novel Parent-Child Interaction Therapy Targets Preschool-Aged Depression
- Remission of Treatment-Resistant Depression in Veterans Depends on Close Clinical Observation
- Medical Clearance of Psych Patients in the ED: Consensus Recommendations
- From Abused Child to Serial Killer: Investigating Nature vs Nurture in Methods of Murder
- Managing Comorbid Migraine and Mood Disorders: A Synergistic Approach
- Dialectical Behavior Therapy Effective in Reducing Suicide Attempts, Self-Harm in Adolescents
- Should Physicians Treat Family and Friends? Three Experts Weigh In
- Effect of Long-Term Lisdexamfetamine Dimesylate for Major Depressive Disorder
- 5-Factor Brief Negative Symptom Scale Validation in Schizophrenia
- Do the Deceased Have Rights to Autonomy? An Ethical Examination of Posthumous Conception
- Mothers' Healthy Lifestyle Tied to Drop in Offspring Obesity
- Parental Incarceration Linked to Unhealthy Behaviors in Teens