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Laronidase Side Effects

For the Consumer

Applies to laronidase: intravenous solution

Along with its needed effects, laronidase 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 laronidase:

More Common

  • Abdominal or stomach pain
  • accumulation of pus
  • back pain
  • black, tarry stools
  • bleeding gums
  • blood in urine or stools
  • blurred vision
  • chest pain
  • chest tightness
  • chills
  • clay-colored stools
  • confusion
  • dark urine
  • dizziness
  • drowsiness
  • facial swelling
  • faintness
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • flushing
  • headache
  • hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site
  • itching
  • lightheadedness when getting up from a lying or sitting position suddenly
  • loss of appetite
  • nausea or vomiting
  • pale skin
  • pinpoint red spots on skin
  • shortness of breath
  • skin rash
  • sweating
  • swollen, red, or tender area of infection
  • trouble breathing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin

Less Common

  • Cough
  • difficulty breathing
  • itching skin
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • redness of skin
  • tightness in chest
  • wheezing

Some side effects of laronidase 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

  • Bleeding, blistering, burning, coldness, or discoloration of skin
  • blindness
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • decreased vision
  • diarrhea
  • difficulty in moving
  • ear congestion
  • feeling of pressure
  • loss of voice
  • muscle pain or stiffness
  • nasal congestion
  • overactive reflexes
  • pain in joints
  • runny nose
  • sneezing
  • sore throat
  • swelling of legs and feet
  • swelling or puffiness of face
  • varicose or spider veins

For Healthcare Professionals

Applies to laronidase: intravenous solution

General

The most frequently reported infusion reactions included pyrexia, chills, blood pressure, increased, tachycardia, and oxygen saturation decreased.

The most frequently reported adverse reactions included rash, upper respiratory tract infection, injection site reaction, hyperreflexia, paresthesia, flushing, and poor venous access.[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction[Ref]

Other

Very common (10% or more): Infusion reactions (up to 49%), pyrexia (up to 30%), otitis media (20%), chills (up to 20%), central venous catheterization required for infusion (15%), oxygen saturation decreased (up to 10%)

Common (1% to 10%): Chest pain, face edema, gravitational/dependent edema, abscess, feeling hot, feeling cold, influenza-like illness, body temperature increased

Frequency not reported: Laryngeal edema, extravasation

Postmarketing reports: Fatigue[Ref]

The most common adverse reactions were infusion reactions; the frequency decreased over time with continued use, and most were classified as mild to moderate in severity. The majority of infusion reactions requiring intervention were ameliorated with slowing of the infusion rate, temporarily stopping the infusion, with or without administering additional antihistamines and/or antipyretics.[Ref]

Gastrointestinal

Very common (10% or more): Nausea, abdominal pain/discomfort

Common (1% to 10%): Vomiting, diarrhea[Ref]

Immunologic

In clinical trials, 99 of 102 patients developed IgG antidrug antibodies. No correlation was demonstrated between presence of antidrug antibodies and therapeutic response or the occurrence of allergic reactions. There was also no consistent association between presence of antibodies that neutralize enzymatic activity and therapeutic response. The potential for antibody neutralization of cellular uptake has not been evaluated. There were 9 patients collectively in clinical studies who experienced severe infusion reactions and were subsequently tested for drug specific IgE antibodies and complement activation. Following testing, 1 of the 9 patients had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both drug specific IgE binding antibodies and complement activation. In a separate open-label study of patients 5 years and younger, none tested positive for IgE. The clinical significance of IgE antibodies has not been established.[Ref]

Very common (10% or more): Antidrug antibody development (97%)

Postmarketing reports: Anaphylactic shock, IgE antibody development, compliment activation[Ref]

Dermatologic

Very common (10% or more): Rash (up to 36%)

Common (1% to 10%): Angioedema, urticaria, pruritus, hyperhidrosis, alopecia, cold sweat

Frequency not reported: Erythema[Ref]

Local

Very common (10% or more): Injection site reaction (up to 18%)

Common (1% to 10%): Injection site pain[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (32%)

Common (1% to 10%): Respiratory distress, dyspnea, cough, wheezing, pulmonary crepitation

Frequency not reported: Bronchospasm, hypoxia, tachypnea, respiratory arrest

Postmarketing reports: Respiratory failure, pneumonia[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 23%), poor venous access/vein disorder (14%), blood pressure increased (up to 10%), tachycardia (up to 10%)

Common (1% to 10%): Hypotension, pallor, peripheral coldness

Frequency not reported: Cyanosis

Postmarketing reports: Cardiorespiratory arrest, cardiac failure[Ref]

Nervous system

Very common (10% or more): Hyperreflexia (14%), paresthesia (14%), headache

Common (1% to 10%): Dizziness, tremor[Ref]

Hematologic

Common (1% to 10%): Thrombocytopenia[Ref]

Hepatic

Common (1% to 10%): Hyperbilirubinemia, bilirubinemia[Ref]

Ocular

Common (1% to 10%): Corneal opacity[Ref]

Musculoskeletal

Very common (10% or more): Arthropathy, arthralgia, back pain, pain in extremity

Common (1% to 10%): Musculoskeletal pain[Ref]

Psychiatric

Common (1% to 10%): Restlessness[Ref]

References

1. "Product Information. Aldurazyme (laronidase)." Genzyme Corporation, Cambridge, MA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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