Palynziq 10 mg/.5mL
pegvaliase-pqpz · INJECTION, SOLUTION · BioMarin Pharmaceutical Inc.
Palynziq is a prescription injection used to lower phenylalanine levels in blood for patients with phenylketonuria (PKU), a genetic disorder where the body cannot break down the amino acid phenylalanine. It works by introducing an enzyme that helps metabolize phenylalanine, reducing the need for strict dietary restrictions.
Key Facts
- Brand Name
- Palynziq
- Generic Name
- pegvaliase-pqpz
- NDC Code (Product)
68135-756- Manufacturer
- BioMarin Pharmaceutical Inc.
- Strength
- 10 mg/.5mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761079
- Drug Class
- Phenylalanine Metabolizing Enzyme [EPC]
- Marketing Start
- 05/24/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. PALYNZIQ is a phenylalanine (Phe)-metabolizing enzyme indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Obtain baseline blood Phe concentration before initiating treatment. ( 2.1 ) Consider premedication for hypersensitivity reactions. ( 2.1 , 5.1 , 5.3 ) The recommended initial dosage for PALYNZIQ is 2.5 mg subcutaneously once weekly for 4 weeks. ( 2.2 ) See the Full Prescribing Information for titration, maintenance, discontinuation, and dose reduction. ( 2.2 ) See Full Prescribing Information for dosage and administration modifications due to anaphylaxis. ( 2.3 ) Obtain blood Phe concentrations every 4 weeks until a maintenance dosage is established. ( 2.4 ) Periodically monitor blood Phe concentrations during maintenance therapy and monitor dietary protein and phenylalanine intake throughout treatment. ( 2.4 ) Rotate injection sites. If more than one injection is needed for a single dose, the injection sites should be at least 2 inches away from each other. ( 2.5 ) 2.1 Important Recommendation Prior to PALYNZIQ Treatment Treatment with PALYNZIQ should be managed by a healthcare provider experienced in the management of PKU. Obtain baseline blood phenylalanine concentration before initiating treatment. Consider premedication with an H 1 -receptor antago…
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Effect of PALYNZIQ on Other PEGylated Products : Monitor for hypersensitivity reactions, including anaphylaxis, with concomitant treatment. ( 7.1 ) 7.1 Effect of PALYNZIQ on Other PEGylated Products In a single dose study of PALYNZIQ in adult patients with PKU, two patients receiving concomitant injections of medroxyprogesterone acetate suspension (a formulation containing PEG 3350) experienced a hypersensitivity reaction. One of the two patients experienced a hypersensitivity reaction on day 15 after a single PALYNZIQ dosage of 0.67 mg within 15 minutes following medroxyprogesterone acetate injectable suspension, and subsequently experienced anaphylaxis on day 89 within 30 minutes after the next dose of medroxyprogesterone acetate injectable suspension. The other patient experienced a hypersensitivity reaction on day 40 after a single PALYNZIQ dosage of 0.08 mg within 10 minutes following medroxyprogesterone acetate injectable suspension. Both patients had high anti-PEG IgG antibody titers at or around the time of the hypersensitivity reactions. In PALYNZIQ clinical trials, the majority of patients developed anti-PEG IgM and IgG antibodies after treatment with …
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and in other sections of labeling: Anaphylaxis [see Warnings and Precautions (5.1) ] Other Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Injection Site Infections [see Warnings and Precautions (5.4) ] Hypophenylalaninemia [see Warnings and Precautions (5.5) ] Most common adverse reactions (at least 20% in either treatment phase) are: injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, nausea, abdominal pain, vomiting, cough, oropharyngeal pain, pruritus, diarrhea, nasal congestion, fatigue, dizziness, and anxiety. ( 6.1 ) Most common adverse reactions in patients who are 12 to less than 18 years of age (at least 20% and greater than in control) are: injection site reactions, arthralgia, headache, pyrexia, hypersensitivity reactions, dizziness, nausea, vomiting, fatigue, and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted…
Frequently Asked Questions
What is Palynziq used for?
Palynziq is a prescription injection used to lower phenylalanine levels in blood for patients with phenylketonuria (PKU), a genetic disorder where the body cannot break down the amino acid phenylalanine. It works by introducing an enzyme that helps metabolize phenylalanine, reducing the need for strict dietary restrictions.
Is Palynziq a controlled substance?
Palynziq is not classified as a controlled substance by the DEA.
What is the generic name for Palynziq?
The generic name for Palynziq is pegvaliase-pqpz. There are no other listed brand versions of pegvaliase-pqpz.
What is the NDC code for Palynziq 10 mg/.5mL?
The NDC (National Drug Code) for Palynziq 10 mg/.5mL is 68135-756, listed by BioMarin Pharmaceutical Inc..
Other Palynziq Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)