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PALYNZIQ (pegvaliase-pqpz)
- Phenylketonuria
10 mg/0.5 mL subcutaneous syringe
- Inject 0.5 milliliter (10 mg) by subcutaneous route once daily in theabdomen, thigh, upper buttocks, or outer upper arm (rotate site)
2.5 mg/0.5 mL subcutaneous syringe
- Inject 0.5 milliliter (2.5 mg) by subcutaneous route once weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 4 weeks
20 mg/mL subcutaneous syringe
- Inject 1 milliliter (20 mg) by subcutaneous route once daily in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
Phenylketonuria
- Inject 0.5 milliliter (10 mg) by subcutaneous route once weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (10 mg) by subcutaneous route once weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for1 week
- Inject 0.5 milliliter (10 mg) by subcutaneous route twice weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (10 mg) by subcutaneous route twice weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 1 week
- Inject 0.5 milliliter (10 mg) by subcutaneous route 4 times per week in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (10 mg) by subcutaneous route 4 times per week in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 1 week
- Inject 0.5 milliliter (10 mg) by subcutaneous route once daily in theabdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (10 mg) by subcutaneous route once daily in theabdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 1 week
- Inject 1 milliliter (20 mg) by subcutaneous route once daily in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 1 milliliter (20 mg) by subcutaneous route once daily in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 24Weeks
- Inject 2 milliliters (40 mg) by subcutaneous route once daily in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 2 milliliters (40 mg) by subcutaneous route once daily in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 16 weeks
- Inject 0.5 milliliter (2.5 mg) by subcutaneous route once weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (2.5 mg) by subcutaneous route once weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 4 weeks
- Inject 0.5 milliliter (2.5 mg) by subcutaneous route twice weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site)
- Inject 0.5 milliliter (2.5 mg) by subcutaneous route twice weekly in the abdomen, thigh, upper buttocks, or outer upper arm (rotate site) for 1 week
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Pregnancy
Severe
Moderate
- None
PALYNZIQ (pegvaliase-pqpz)
- Phenylketonuria
- Hypersensitivity drug reaction
- Acute abdominal pain
- Arthralgias
- Cough
- Diarrhea
- Fatigue
- Headache disorder
- Injection site sequelae
- Nausea
- Pain in oropharynx
- Pruritus of skin
- Skin rash
- Vomiting
More Frequent
Severe
Less Severe
- Anaphylaxis
- Angioedema
- Serum sickness
- Alopecia
- Nasal congestion
- Skin inflammation
- Symptoms of anxiety
- Urticaria
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- None
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Pegvaliase-pqpz
No pediatric safety and efficacy established.
- 1 Day – 18 Years
- No pediatric safety and efficacy established.
Pegvaliase-pqpz
- Severity Level:
D
- Additional Notes: Based on drug pharmacology developmental toxicity is possible.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Pegvaliase-pqpz
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- This medication has caused serious allergic reactions which can be life-threatening. This reaction can happen at any time during treatment. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: flushing/rash, itching/swelling (especially of the face, tongue, throat), severe dizziness, trouble breathing, fast heartbeat, fainting, chest discomfort/tightness, nausea, vomiting, or diarrhea.<br /><br />To be sure that you do not have a serious reaction, you will need to stay in a health care setting (such as a doctor's office) for at least 1 hour after taking this drug for the first time so your doctor can carefully monitor you and provide medical help if needed. After the first injection, you and your doctor may decide you can use this medication at home. Your health care provider will instruct you and/or your caregiver how to inject this medication the right way.<br /><br /> Your doctor will also prescribe another medication (epinephrine) in case you have a serious allergic reaction outside the health care setting. Read the Patient Information Leaflet for this medication provided by your pharmacist. Learn ahead of time when and how to use your brand of epinephrine.<br /><br />If you have to use it, get medical help as soon as you have used it. For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Palynziq REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
| Phenylketonuria | |
| E70.0 | Classical phenylketonuria |
| 0-9 | A-Z |
|---|---|
| E70.0 | Classical phenylketonuria |
Formulary Reference Tool