Applies to vestronidase alfa: intravenous solution.
Warning
Intravenous route (Solution)
Anaphylaxis has occurred with vestronidase alfa-vjbk administration, as early as the first dose, therefore appropriate medical support should be readily available when vestronidase alfa-vjbk is administered. Closely observe patients during and for 60 minutes after vestronidase alfa-vjbk infusion. Immediately discontinue the vestronidase alfa-vjbk infusion if the patient experiences anaphylaxis.
Serious side effects of Vestronidase alfa
Along with its needed effects, vestronidase 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 vestronidase alfa:
Rare
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- pale skin, pain, or redness at the injection site
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- tightness in the chest
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Fever with seizures
Other side effects of Vestronidase alfa
Some side effects of vestronidase 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:
Rare
- Diarrhea
- swelling at the injection site
For Healthcare Professionals
Applies to vestronidase alfa: intravenous solution.
General
The most frequently reported side effects were infusion site extravasation, diarrhea, rash, anaphylaxis, infusion site swelling, peripheral swelling, and pruritus.[Ref]
Immunologic
Very common (10% or more): Anti-drug antibodies developed (78%), neutralizing antibodies developed (55.6%), anaphylaxis (16.67%)[Ref]
Nervous system
Frequency not reported: Febrile convulsion[Ref]
A week 66 of treatment, 1 patient experiences a febrile convulsion during infusion of a 4 mg/kg dose. The infusion was stopped and the patient was given anticonvulsants, antipyretics, and antibiotics and the adverse reaction resolved. The patient was subsequently rechallenged without recurrence and continued on treatment with this drug.[Ref]
Dermatologic
Very common (10% or more): Rash (25%)
Common (1% to 10%): Pruritus[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (25%)[Ref]
Other
Common (1% to 10%): Peripheral swelling[Ref]
Local
Very common (10% or more): Infusion site extravasation (33.3%)
Common (1% to 10%): Infusion site swelling[Ref]
