Note: This document contains side effect information about pegvaliase. Some of the dosage forms listed on this page may not apply to the brand name Palynziq.
Applies to pegvaliase: subcutaneous solution
Subcutaneous route (Solution)
Anaphylaxis has been reported after administration of pegvaliase-pqpz and may occur at any time during treatment. Administer the initial dose of pegvaliase-pqpz under the supervision of a healthcare provider equipped to manage anaphylaxis, and closely observe patients for at least 60 minutes following injection. Prior to self-injection, confirm patient competency with self-administration, and patient’s and observer’s ability to recognize signs and symptoms of anaphylaxis and to administer auto-injectable epinephrine, if needed. Prescribe auto-injectable epinephrine. Prior to first dose, instruct the patient and observer (if applicable) on its appropriate use. Instruct the patient to seek immediate medical care upon its use. Instruct patients to carry auto-injectable epinephrine with them at all times during pegvaliase-pqpz treatment. Pegvaliase-pqpz is available only through a restricted program called the Palynziq(TM) REMS.
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:
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:
Applies to pegvaliase: subcutaneous solution
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.
Very common (10% or more): Hypersensitivity reactions (up to 69%)
Common (1% to 10%): Anaphylaxis
During clinical trials, a total of 37 anaphylactic episodes were reported in 26 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 84% (28/37) of the reported anaphylaxis episodes. One additional case occurred within the first year of dosing (78%; 29/37 episodes), and the remaining cases occurred after one year of dosing and up to 834 days (2.3 years) into treatment.
Hypersensitivity reactions other than anaphylaxis have been reported in 69% of patients (196/285). 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, and allergic cough.
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, and dryness
Very common (10% or more): Injection site reactions (up to 88%)
Generalized skin reactions include pruritus, rash, urticaria, dry skin, rash erythematous, erythema, cellulitis, rash macular, pruritus generalized, petechiae, dermatitis allergic, skin infection, skin induration, rash maculo-papular, rash generalized, pharyngeal edema, macule, granulomatous dermatitis, exfoliative rash, drug eruption, dermatitis atopic, dermatitis, xanthogranuloma, skin plaque, skin mass, skin lesion, skin hypopigmentation, skin hypertrophy, skin hyperpigmentation, skin exfoliation, septal panniculitis, scleroderma, scar, rash pruritic, rash papular, psoriatic arthropathy, pruritus allergic, papule, necrobiosis lipoidica diabeticorum, furuncle, eczema, ecchymosis, dermatitis psoriasiform, dermatitis infected, and blister.
Very common (10% or more): Generalized skin reaction lasting at least 14 days (up to 37%), pruritus (up to 24%), alopecia (up to 17%)
Very common (10% or more): Nausea (up to 26%), abdominal pain (up to 25%), oropharyngeal pain (up to 23%), vomiting (up to 26%), diarrhea (up to 22%)
Arthralgia includes: Pain in extremity, back pain, musculoskeletal pain, and neck pain.
Very common (10% or more): Arthralgia (up to 74%)
Very common (10% or more): Anxiety (up to 18%)
Very common (10% or more): Cough (up to 22%), nasal congestion (up to 18%)
Very common (10% or more): Fatigue (up to 22%)
Very common (10% or more): Headache (up to 50%)
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Palynziq