Applies to etranacogene dezaparvovec: intravenous suspension.
Serious side effects
Along with its needed effects, etranacogene dezaparvovec 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 etranacogene dezaparvovec:
More common
- Dizziness
- facial swelling
- fever or chills
- headache
- nausea or vomiting
- skin rash
- trouble breathing
- weakness
Less common
- Chest discomfort or tightness
- fast, pounding, or irregular heartbeat or pulse
- hives, itching
- irritation
- joint pain, stiffness, or swelling
- redness or the skin
- swelling of the eyelids, face, lips, hands, or feet
Other side effects
Some side effects of etranacogene dezaparvovec 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
- Cough
- diarrhea
- general feeling of discomfort or illness
- loss of appetite
- muscle aches and pains
- runny nose
- shivering
- sore throat
- sweating
- trouble sleeping
- unusual tiredness or weakness
Less common
- Stomach pain
For Healthcare Professionals
Applies to etranacogene dezaparvovec: intravenous suspension.
Gastrointestinal
Common (1% to 10%): Nausea[Ref]
General
The most common adverse reactions reported were alanine amino transaminase (ALT) elevations, headache, blood creatine kinase elevations, flu-like symptoms, infusion-related reactions, fatigue, malaise, and aspartate transaminase (AST) elevations.[Ref]
Hepatic
Very common (10% or more): Elevated ALT (42%), elevated AST (42%)[Ref]
Hypersensitivity
Very common (10% or more): Infusion-related reactions (33%)
Common (1% to 10%): Hypersensitivity[Ref]
Local
Very common (10% or more): Malaise (12%)[Ref]
Musculoskeletal
Very common (10% or more): Increased blood creatine kinase (42%)
Other
Very common (10% or more): Fatigue (12%), flu-like symptoms (14%)[Ref]
Nervous system
Very common (10% or more): Headache (18%)[Ref]
