Laronidase Side Effects

It is possible that some side effects of laronidase may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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 serious side effects reported with laronidase during clinical trials were anaphylactic and allergic reactions. The majority of side effects reported in clinical trials were considered disease-related and unrelated to study drug. The most common side effects were infusion reactions. Infusion reactions decreased in frequency over time with continued use of laronidase, and most were considered mild to moderate in severity. Most infusion reactions requiring intervention were ameliorated by slowing the infusion rate or temporarily stopping the infusion, with or without administering additional treatments (including antihistamines, antipyretics, or both).

During clinical trials, all patients were treated with antipyretics and antihistamines prior to the infusions.

Hypersensitivity

Some reactions were life-threatening and included respiratory failure, respiratory distress, stridor, tachypnea, bronchospasm, obstructive airways disorder, hypoxia, hypotension, bradycardia, and urticaria.

In patients with MPS I, preexisting upper airway obstruction may have contributed to the severity of some allergic reactions.

At least 1 patient had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both laronidase-specific IgE binding antibodies and complement activation.

About 1% of patients experienced severe or serious infusion allergic reactions and tested positive for IgE during postmarketing experience.

Frequency not reported: Anaphylactic reactions/anaphylaxis, allergic reactions
Postmarketing reports: Severe or serious infusion allergic reactions (some life-threatening), anaphylactic shock

Other

Patients with an acute febrile or respiratory illness at the time of laronidase infusion may be at greater risk for infusion reactions. One patient with acute bronchitis and hypoxia experienced increased tachypnea during the first laronidase infusion that resolved without intervention. The patient's respiratory symptoms returned within 30 minutes of completing the infusion and responded to bronchodilator therapy. Approximately 6 hours after the infusion, the patient experienced coughing, then respiratory arrest, and died.

Study 1 was a 26-week, double-blind, placebo-controlled clinical study of laronidase conducted in 45 patients with MPS I, ages 6 to 43 years old. The most commonly reported infusion reactions in Study 1 were flushing (23%), pyrexia, headache, and rash. Less common infusion reactions included angioedema (including face edema), hypotension, paresthesia, feeling hot, hyperhidrosis, tachycardia, vomiting, back pain, and cough.

All 45 patients who completed Study 1 continued treatment in Study 2, an open-label, uncontrolled extension study. The most commonly reported infusion reactions in Study 2 included rash (13%), flushing (11%), pyrexia (11%), headache (9%), abdominal pain or discomfort (9%), and injection site reaction (9%). Less commonly reported infusion reactions included nausea (7%), diarrhea (7%), feeling hot or cold (7%), vomiting (4%), pruritus (4%), arthralgia (4%), and urticaria (4%).

Study 3 was a 52-week, open-label, uncontrolled study of 20 MPS I patients, ages 6 months to 5 years old (at enrollment). Otitis media and central venous catheterization required for laronidase infusion were reported in Study 3. The most commonly reported infusion reactions in Study 3 included pyrexia (30%), chills (20%), increased blood pressure (10%), tachycardia (10%), and decreased oxygen saturation (10%). Other commonly reported infusion reactions (occurring in greater than or equal to 5% of patients) were pallor, tremor, respiratory distress, wheezing, pulmonary crepitations, pruritus, and rash.

Facial edema has occurred in a few patients who had MPS I-related upper airway and pulmonary involvement.

Very common (10% or more): Infusion reactions (up to 49%), pyrexia (up to 30%), flushing (up to 23%), chills (20%), otitis media (20%), central venous catheterization required for laronidase infusion (15%)
Common (1% to 10%): Chest pain (9%), face edema (9%), gravitational edema (9%), abscess (9%), feeling hot or cold (up to 7%), pallor (5% or greater)
Postmarketing reports: Extravasation, fatigue, peripheral edema

Dermatologic

Very common (10% or more): Rash (up to 36%)
Common (1% to 10%): Pruritus (up to 5% or greater), urticaria (up to 4%)
Frequency not reported: Angioedema (including face edema), hyperhidrosis, cold sweat, alopecia
Postmarketing reports: Erythema

Respiratory

Very common (10% or more): Respiratory tract infection (32%)
Common (1% to 10%): 5% or greater: Respiratory distress, wheezing, pulmonary crepitations
Frequency not reported: Bronchospasm, dyspnea, cough, stridor, tachypnea, obstructive airways disorder, hypoxia
Postmarketing reports: Cyanosis, cardiorespiratory arrest, respiratory failure, pneumonia, laryngeal edema

Side effects resulting in death during postmarketing experience have included cardiorespiratory arrest, respiratory failure, and pneumonia in MPS I patients with significant underlying disease.

Local

Very common (10% or more): Injection site reaction (up to 18%)
Common (1% to 10%): Injection site pain (9%)

Cardiovascular

Side effects resulting in death during postmarketing experience have included cardiac failure in MPS I patients with significant underlying disease.

Very common (10% or more): Poor venous access (14%), increased blood pressure (10%)
Common (1% to 10%): Tachycardia (up to 10%), hypotension (up to 9%)
Frequency not reported: Bradycardia
Postmarketing reports: Cardiac failure

Nervous system

Very common (10% or more): Hyperreflexia (14%), paresthesia (up to 14%)
Common (1% to 10%): Headache (up to 9%), tremor (5% or greater)
Frequency not reported: Dizziness

Immunologic

No association established between presence of IgG antibodies to laronidase and therapeutic response or development of allergic reactions.

At least 1 patient had an anaphylactic reaction consisting of urticaria and airway obstruction and tested positive for both laronidase-specific IgE binding antibodies and complement activation.

About 1% of patients experienced severe or serious infusion allergic reactions and tested positive for IgE during postmarketing experience.

Very common (10% or more): Positive for IgG antibodies to laronidase (97%)
Rare (less than 0.1%): Complement activation (at least 1 case)
Postmarketing reports: Positive for IgE

Metabolic

Very common (10% or more): Decreased oxygen saturation (10%)

Hematologic

Common (1% to 10%): Thrombocytopenia (9%)

Hepatic

Common (1% to 10%): Hyperbilirubinemia (9%)

Ocular

Common (1% to 10%): Corneal opacity (9%)

Gastrointestinal

Common (1% to 10%): Abdominal pain or discomfort (9%), nausea (7%), diarrhea (7%), vomiting (up to 4%)

Musculoskeletal

Common (1% to 10%): Arthralgia (4%), back pain, musculoskeletal pain

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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