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Pegvaliase Side Effects

Medically reviewed by Drugs.com. Last updated on May 20, 2020.

For the Consumer

Applies to pegvaliase: subcutaneous solution

Warning

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.

Side effects requiring immediate medical attention

Along with its needed effects, pegvaliase 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:

More common

  • Cough
  • diarrhea
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • fever
  • hives, itching, skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • nausea
  • numbness or tingling of the face, hands, or feet
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness and soreness of the eyes
  • sores in the mouth
  • stomach pain
  • swelling of the feet or lower legs
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
  • vomiting

Rare

  • Feeling of discomfort
  • joint swelling
  • swollen lymph glands

Side effects not requiring immediate medical attention

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:

More common

  • Anxiety
  • bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • difficulty in moving
  • headache
  • loss or thinning of hair
  • muscle stiffness
  • pain in the mouth and throat
  • stuffy nose

For Healthcare Professionals

Applies to pegvaliase: subcutaneous solution

General

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 69%)

Common (1% to 10%): Anaphylaxis

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 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.

Local

Very common (10% or more): Injection site reactions (up to 88%)

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

Dermatologic

Very common (10% or more): Generalized skin reaction lasting at least 14 days (up to 37%), pruritus (up to 24%), alopecia (up to 17%)

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.

Gastrointestinal

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%)

Musculoskeletal

Very common (10% or more): Arthralgia (up to 74%)

Arthralgia includes: Pain in extremity, back pain, musculoskeletal pain, and neck pain.

Psychiatric

Very common (10% or more): Anxiety (up to 18%)

Respiratory

Very common (10% or more): Cough (up to 22%), nasal congestion (up to 18%)

Other

Very common (10% or more): Fatigue (up to 22%)

Nervous system

Very common (10% or more): Headache (up to 50%)

References

1. "Product Information. Palynziq (pegvaliase)." BioMarin Pharmaceutical Inc, Novato, CA.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.