Palynziq Side Effects

Generic name: pegvaliase

Medically reviewed by Drugs.com. Last updated on Aug 20, 2024.

Note: This document provides detailed information about Palynziq Side Effects associated with pegvaliase. Some dosage forms listed on this page may not apply specifically to the brand name Palynziq.

Applies to pegvaliase: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for serious unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine. Keep with you an epinephrine autoinjector pen at all times in case of a severe allergic reaction.

Patients will be given a Palynziq® information card that they should carry with them at all times. This card describes symptoms of an unwanted effect which may occur. Always show this card to any healthcare professional who may treat you.

Serious side effects of Palynziq

Along with its needed effects, pegvaliase (the active ingredient contained in Palynziq) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pegvaliase:

Other side effects of Palynziq

Some side effects of pegvaliase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to pegvaliase: subcutaneous solution.

General adverse events

The most commonly reported adverse reactions have included injection site reactions, arthralgia, hypersensitivity reactions, headache, generalized skin reactions lasting at least 14 days, pruritus, nausea, abdominal pain, oropharyngeal pain, vomiting, cough, diarrhea, and fatigue.^[Ref]

Hypersensitivity

• Very common (10% or more): Hypersensitivity reactions (up to 65%)
• Common (1% to 10%): Anaphylaxis, acute systemic hypersensitivity reaction, serum sickness^[Ref]

During clinical trials, a total of 42 anaphylactic episodes were reported in 29 patients (n=285). The rate of anaphylaxis was highest during induction and titration phase. Signs and symptoms of anaphylaxis included syncope, hypotension, hypoxia, dyspnea, wheezing, chest discomfort/chest tightness, tachycardia, angioedema (swelling of face, lips, eyes, tongue), throat tightness, skin flushing, rash, urticaria, pruritus, and gastrointestinal symptoms (vomiting, nausea, diarrhea). Anaphylaxis occurred within 1 hour in 81% (34/42) of the reported anaphylaxis episodes. Most episodes occurred within the first year of dosing (69%, 29/42 episodes), however, cases also occurred after one year of dosing and up to 1604 days (4.4 years) into treatment. Twenty one out of the 29 (72%) patients who experienced anaphylaxis were rechallenged and 6 out of the 21 (29%) had recurrence of anaphylaxis. All anaphylaxis episodes resolved without sequelae.

Hypersensitivity reactions other than anaphylaxis have been reported in 72% of patients (204/285). Hypersensitivity reactions have included rash, urticaria, anaphylaxis, rash generalized, hypersensitivity, rash erythematous, rash maculo-papular, rash pruritic, serum sickness, swelling face, dermatitis contact, swollen tongue, lip swelling, rash macular, pharyngeal edema, injection site hypersensitivity, eczema, drug eruption, dermatitis allergic, dermatitis, tongue edema, palatal edema, edema mouth, multiple allergies, lip edema, eye edema, exfoliative rash, drug hypersensitivity, dermatitis atopic, dermatitis acneiform, pruritus allergic, mouth swelling, implant site rash, gingival swelling, face edema, eyelid edema, eye swelling, dermatitis psoriasiform, dermatitis infected, conjunctivitis allergic, bronchospasm, angioedema, allergic sinusitis, allergic cough, eczema nummular, and rhinitis allergic.^[Ref]

Immunologic

• Very common (10% or more): Anti-phenylalanine ammonia lyase (PAL) immunoglobulin G (IgG) antibodies (up to 99.6%), anti-PAL IgM antibodies (up to 98%), anti-drug IgE antibodies (up to 96%), sustained total anti-drug antibody response (up to 91%), neutralizing antibodies (up to 89%), complement factor C3 decreased (up to 84%), complement factor C4 decreased (up to 64%)^[Ref]

Local

• Very common (10% or more): Injection site reactions (up to 93%)^[Ref]

Injection site reactions have included: Erythema, pruritus, pain, bruising, rash, swelling, urticaria, induration, hemorrhage, edema, mass, inflammation, nodule, discoloration, warmth, hematoma, irritation, vesicles, hypersensitivity, papule, discomfort, scar, paresthesia, hypertrophy, extravasation, scab, and dryness^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 86%), blood creatinine phosphokinase above upper limit of normal (up to 48%), myalgia (up to 12%)
• Common (1% to 10%): Joint swelling, musculoskeletal stiffness, joint stiffness^[Ref]

Arthralgia included: Pain in extremity, back pain, musculoskeletal pain, and neck pain^[Ref]

Other

• Very common (10% or more): C-reactive protein (CRP) above upper limit of normal (up to 71%), fatigue (up to 24%), high sensitivity CRP levels increased (up to 17%)^[Ref]

Metabolic

• Very common (10% or more): Hypophenylalaninemia (up to 65%)^[Ref]

Hypophenylalaninemia (blood phenylalanine level below 30 micromol/L) on a single measurement was reported in up to 65% of patients; hypophenylalaninemia on at least 2 consecutive measurements was reported in up to 49% of patients.^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 56%), dizziness (up to 21%)^[Ref]

Headache included migraine and sinus headache.^[Ref]

Dermatologic

• Very common (10% or more): Generalized skin reaction lasting at least 14 days (up to 47%), rash (up to 33%), pruritus (up to 27%), urticaria (up to 25%), alopecia (up to 21%), erythema (up to 11%)
• Common (1% to 10%): Skin exfoliation, maculopapular rash, angioedema^[Ref]

Generalized skin reactions included pruritus, rash, urticaria, dry skin, rash erythematous, erythema, cellulitis, rash macular, pruritus generalized, petechiae, dermatitis allergic, skin infection, skin induration, rash maculopapular, rash generalized, pharyngeal edema, macule, granulomatous dermatitis, exfoliative rash, drug eruption, dermatitis atopic, dermatitis, xanthogranuloma, skin plaque, skin mass, skin lesion, skin hypopigmentation, skin hyperpigmentation, skin exfoliation, septal panniculitis, scar, rash pruritic, rash papular, psoriatic arthropathy, pruritus allergic, papule, necrobiosis lipoidica diabeticorum, furuncle, eczema, ecchymosis, dermatitis psoriasiform, dermatitis infected, blister, eczema nummular, granuloma, infected dermal cyst, lipohypertrophy, psoriasis, and skin irritation.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (up to 31%), abdominal pain (up to 30%), oropharyngeal pain (up to 29%), vomiting (up to 30%), diarrhea (up to 27%)^[Ref]

Abdominal pain included upper abdominal pain and abdominal discomfort.^[Ref]

Respiratory

• Very common (10% or more): Cough (up to 30%), nasal congestion (up to 27%)^[Ref]

Psychiatric

• Very common (10% or more): Anxiety (up to 21%)^[Ref]

Hematologic

• Very common (10% or more): Lymphadenopathy (up to 16%)^[Ref]

See also:

Frequently asked questions

• What is Palynziq used to treat?

Further information

Palynziq side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer