Pegvaliase

Generic name: Pegvaliase
Brand names: Palynziq
Dosage form: subcutaneous solution (10 mg/0.5 mL; 2.5 mg/0.5 mL; 20 mg/mL)
Drug class: Miscellaneous metabolic agents

Usage of Pegvaliase

Pegvaliase is used to lower phenylalanine blood levels in adults with phenylketonuria (PKU) not controlled with other treatment.

Pegvaliase is available only from a certified pharmacy under a special program.

Pegvaliase may also be used for purposes not listed in this medication guide.

Pegvaliase side effects

Stop the pegvaliase injection and get emergency medical help if you have signs of an allergic reaction:

hives, rash, itching;

confusion, dizziness, feeling like you might pass out;

nausea, vomiting, diarrhea;

loss of bladder or bowel control;

fast heartbeats;

wheezing, chest tightness, difficult breathing;

flushing (warmth, redness, or tingly feeling); or

swelling of your face, lips, tongue, or throat.

Common side effects of pegvaliase may include:

cough, stuffy nose;

mouth and throat pain;

dizziness;

anxiety;

low phenylalanine blood levels;

a spreading skin reaction (itching, redness, rash) that could last at least 14 days;

headache, joint pain;

nausea, vomiting, stomach pain, diarrhea;

tiredness; or

pain, tenderness, bruising, redness, itching, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Pegvaliase

Pegvaliase can cause a serious allergic reaction. Your doctor may prescribe an Epinephrine injection kit to use in case you have a severe allergic reaction. Keep this injection kit with you at all times.

Tell your doctor if you think you might be unable to give yourself an emergency epinephrine injection.

Follow your doctor's instructions about using pegvaliase if you are pregnant. Controlling your phenylalanine levels is very important during pregnancy. Your name may be listed on a pregnancy registry to track the effects of pegvaliase on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

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How to use Pegvaliase

Usual Adult Dose for Phenylketonuria:

INDUCTION: 2.5 mg suBCutaneously once a week for 4 weeks-Titrate in a step-wise manner as tolerated over at least 5 weeks (described below); additional time may be required prior to each dose escalation based on tolerability RECOMMENDED TITRATION SCHEDULE: Week 1: 2.5 mg subcutaneously twice a week Week 2: 10 mg subcutaneously once a weekWeek 3: 10 mg subcutaneously twice a weekWeek 4: 10 mg subcutaneously four times a weekWeek 5: 10 mg subcutaneously once a day Week 6: 20 mg subcutaneously once a day-After at least 24 weeks at 20 mg/day, may consider increasing dose to 40 mg/day for patients unable to achieve blood phenylalanine control-After at least 16 weeks at 40 mg/day, may consider increasing dose to 60 mg/day for patients unable to achieve blood phenylalanine controlMAINTENANCE DOSE: 20 to 60 mg subcutaneously once a day; maintenance dose should be individualized to achieve blood phenylalanine control (blood phenylalanine concentrations less than or equal to 600 micromol/L) MAXIMUM DOSE: -If, after 16 weeks at 60 mg/day, patient has not achieved an adequate response, therapy should be discontinuedComments:-Administer initial dose under the supervision of a healthcare provider; treatment should be managed by a healthcare provider experienced in the management of PKU. -Obtain baseline blood phenylalanine concentration; assess tolerability, blood phenylalanine concentrations, and dietary protein and phenylalanine intake throughout treatment. -Therapeutic response may not be achieved until titration to an effective maintenance dose is achieved; individualize dose, use lowest effective and tolerated dose. Use: To reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management.

Warnings

Pegvaliase can cause a serious allergic reaction. Your first dose will be given in a medical setting.

Get emergency medical help if you have signs of an allergic reaction such as hives, itching, dizziness, wheezing, trouble breathing, or swelling in your face or throat. Your doctor may prescribe an epinephrine injection kit to keep with you at all times.

What other drugs will affect Pegvaliase

Other drugs may affect pegvaliase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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