Olipudase alfa Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.

Applies to olipudase alfa: intravenous powder for solution.

Serious side effects of Olipudase alfa

Along with its needed effects, olipudase alfa 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 or nurse immediately if any of the following side effects occur while taking olipudase alfa:

More common

• Blurred vision
• body aches or pain
• chest tightness
• confusion
• cough
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dryness or soreness of the throat
• fast, pounding, or irregular heartbeat or pulse
• fever
• hives, itching, or skin rash
• hoarseness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• trouble breathing
• trouble in swallowing
• unusual tiredness or weakness
• voice changes

Incidence not known

• Back pain
• chills
• headache
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea and vomiting

Other side effects of Olipudase alfa

Some side effects of olipudase alfa 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

• Diarrhea
• difficulty in moving
• flushing, redness of the skin
• lack or loss of strength
• muscle or joint pain
• redness of the eye
• sneezing
• throat irritation
• unusually warm skin

For Healthcare Professionals

Applies to olipudase alfa: intravenous powder for injection.

General

The most frequently reported adverse reactions were headache, pyrexia, urticaria, nausea, vomiting, abdominal pain, myalgia, pruritus, and increased C-reactive protein. In 1 trial, treatment-related serious adverse reactions occurred in a higher percentage of pediatric patients than in adult patients.^[Ref]

Cardiovascular

In 1 trial, hypotension was reported in 15% of adult patients (n=13); hypotension and tachycardia were each reported in 13% of pediatric patients (n=8).

Extrasystoles occurred in an adult patient with history of cardiomyopathy.

Common (1% to 10%): Palpitations, tachycardia, hypotension, hot flush, flushing, extrasystoles

Dermatologic

Very common (10% or more): Urticaria (up to 21.7%), pruritus (10%)

Common (1% to 10%): Angioedema, fixed eruption, rash, papular rash, macular rash, maculopapular rash, erythematous rash, pruritic rash, morbilliform rash, papule, macule, erythema

In 1 trial, erythema, urticaria, and papule were each reported in 8% of adult patients (n=13); urticaria, rash, and pruritus were reported in 50%, 38%, and 25% of pediatric patients (n=8), respectively. Rash included rash and erythema.

Gastrointestinal

In 1 trial, diarrhea was reported in 15% of adult patients (n=13); diarrhea, abdominal pain, vomiting, and nausea were reported in 75%, 63%, 50%, and 38% of pediatric patients (n=8), respectively. Abdominal pain included abdominal pain and upper abdominal pain.

Very common (10% or more): Nausea (up to 20%), vomiting (up to 16.7%), abdominal pain (up to 15%)

Common (1% to 10%): Diarrhea, upper abdominal pain, abdominal discomfort, gastrointestinal pain

Hepatic

Common (1% to 10%): Hepatic pain, increased ALT, increased AST

Frequency not reported: Elevated transaminase levels

Elevated transaminase levels (ranging from 3 to 14 times the upper limit of normal) were reported in 4 (13%) adult patients and 1 (13%) pediatric patient during the dose escalation phase in clinical trials.

Hypersensitivity

Very common (10% or more): Hypersensitivity-related infusion-associated reactions (up to 26.7%)

Common (1% to 10%): Anaphylactic reaction, hypersensitivity

Hypersensitivity-related infusion-associated reactions (including anaphylaxis) occurred in 26.7% patients (17.5% adult and 45% pediatric patients) in clinical trials. The most frequently reported hypersensitivity-related infusion-associated reaction symptoms were urticaria, pruritus, erythema, and rash.

Anaphylactic reactions were reported in 3 pediatric patients. An 18-month-old patient treated with this drug experienced an anaphylactic reaction during the sixth infusion in the dose escalation period. A 16-month-old patient with acid sphingomyelinase deficiency (ASMD) type A, treated with a version of this drug manufactured from a different process, experienced 2 anaphylactic reactions during the fifth and sixth infusions in the dose escalation period; the patient received an immune tolerance induction therapy prior to treatment. In the postmarketing setting, a 32-month-old patient experienced an anaphylactic reaction.

Hypersensitivity reactions (including anaphylaxis) occurred in a higher percentage of pediatric patients than in adult patients. Hypersensitivity reactions that were mild to moderate in severity occurred in 10 (33%) adult patients and 4 (50%) pediatric patients in clinical trials. Hypersensitivity reactions in adult patients included urticaria, pruritus, erythema, rash, erythematous rash, eczema, angioedema, and erythema nodosum. Hypersensitivity reactions in pediatric patients included urticaria, pruritus, rash, erythema, and localized edema. In 1 trial, anaphylactic reaction and hypersensitivity were each reported in 13% of pediatric patients (n=8).

Immunologic

Overall, 16 of 40 (40%) adult patients and 13 of 20 (65%) pediatric patients treated with this drug developed treatment-emergent antidrug antibodies (ADA); the median time to seroconversion from first infusion was about 33 weeks in adult patients and 10 weeks in pediatric patients. Most ADA-positive patients (11 of 16 adult and 8 of 13 pediatric patients) had a low ADA response (up to 400) or reverted to ADA-negative. Of the ADA-positive patients, 4 of 16 adult and 5 of 13 pediatric patients had neutralizing antibodies that inhibited the activity of this drug; 6 patients developed neutralizing antibodies at a single time point and 3 patients had an intermittent response. A pediatric patient had a treatment boosted ADA response. Another pediatric patient had an anaphylactic reaction and developed IgE ADA and IgG ADA with a peak titer of 1600.

No effect of ADA was observed on pharmacokinetics and efficacy of this drug in adult and pediatric patients. There was a higher percentage of patients with treatment-emergent infusion-associated reactions (including hypersensitivity reactions) in patients who developed treatment-emergent ADA versus those who did not (75.9% versus 41.9%).

Very common (10% or more): Development of antidrug antibodies

Frequency not reported: Immunoglobulin G (IgG) antidrug antibodies present, IgE antidrug antibodies present, neutralizing antibodies present

Local

Common (1% to 10%): Catheter site pain, catheter site related reaction, catheter site pruritus, catheter site swelling

Frequency not reported: Infusion-site swelling

In 1 trial, infusion-site swelling was reported in 13% of pediatric patients (n=8).

Musculoskeletal

In 1 trial, myalgia was reported in 8% of adult patients (n=13); arthralgia was reported in 38% of pediatric patients (n=8).

Very common (10% or more): Myalgia (up to 11.7%)

Common (1% to 10%): Bone pain, arthralgia, back pain

Nervous system

In 1 trial, headache was reported in 54% of adult patients (n=13) and 50% of pediatric patients (n=8).

Very common (10% or more): Headache (up to 31.7%)

Ocular

In 1 trial, ocular hyperemia was reported in 15% of adult patients (n=13).

Common (1% to 10%): Ocular hyperemia, ocular discomfort, eye pruritus

Other

Infusion-associated reactions (IARs) were reported in 55% of adult and 65% of pediatric patients. IAR symptoms reported most frequently in adult patients were headache, nausea, urticaria, arthralgia, myalgia, pyrexia, pruritus, vomiting, and abdominal pain. IAR symptoms reported most frequently in pediatric patients were pyrexia, urticaria, vomiting, headache, nausea, and rash. IARs typically occurred between the time of infusion and 24 hours after infusion end.

In 1 trial, asthenia and abnormal C-reactive protein were each reported in 8% of adult patients (n=13); pyrexia, fatigue, and increased C-reactive protein were reported in 100%, 25%, and 13% of pediatric patients (n=8), respectively. Fatigue included fatigue and asthenia.

In 2 adult and 3 pediatric patients, IAR symptoms were associated with changes in laboratory parameters (e.g., C-reactive protein, ferritin value) indicative of acute phase reaction. Most of the acute phase reactions occurred at 48 hours post-infusion during the dose escalation period. Elevations of C-reactive protein, calcitonin, and interleukin 6, and reduction of serum iron were observed. The most common clinical symptoms associated with acute phase reactions were pyrexia, vomiting, and diarrhea. Acute phase reactions were managed similar to other IARs. In the postmarketing setting, 24 hours after receiving this drug at a higher than recommended initial dose, a 2-year-old male patient with ASMD experienced fever, respiratory distress, hypotension, and death.

Very common (10% or more): Infusion-associated reactions (up to 65%), pyrexia (up to 25%), increased C-reactive protein (10%)

Common (1% to 10%): Pain, chills, fatigue, asthenia, increased serum ferritin, abnormal C-reactive protein, increased body temperature

Frequency not reported: Acute phase reaction

Respiratory

Common (1% to 10%): Pharyngeal edema, pharyngeal swelling, throat tightness, wheezing, larynx irritation, dyspnea, throat irritation

In 1 trial, cough, pharyngitis, dyspnea, and throat irritation were reported in 31%, 8%, 8%, and 8% of adult patients (n=13), respectively; cough, rhinitis, pharyngitis, and pharyngeal swelling were reported in 75%, 75%, 25%, and 13% of pediatric patients (n=8), respectively.

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