Applies to laronidase: intravenous solution.
Warning
Intravenous route (Solution)
Life-threatening anaphylactic reactions have been observed in some patients during laronidase infusions. Appropriate medical support should be readily available when laronidase is administered. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory condition due to infusion reactions and need additional monitoring.
Serious side effects of Laronidase
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
Other side effects of Laronidase
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
Very common (10% or more): Antidrug antibody development (97%)
Postmarketing reports: Anaphylactic shock, IgE antibody development, compliment activation[Ref]
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]
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]
