Applies to valoctocogene roxaparvovec: intravenous suspension.
Serious side effects
Along with its needed effects, valoctocogene roxaparvovec 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 valoctocogene roxaparvovec:
More common
- Back pain
- blurred vision
- chest tightness
- chills
- confusion
- cough
- diarrhea
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- fever
- flushing
- headache
- hives, itching, skin rash
- nausea and vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- runny nose
- shivering
- sweating
- tingling of the throat
- trouble breathing
- unusual tiredness or weakness
- watery eyes
Less common
- Loss of appetite
- stomach pain
Incidence not known
- Dark urine
- pains in the chest, groin, or legs, especially the calves of the legs
- severe headaches of sudden onset
- sudden loss of coordination
- sudden onset of slurred speech
- sudden vision changes
- yellow eyes or skin
Other side effects
Some side effects of valoctocogene roxaparvovec 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
- General feeling of discomfort or illness
- headache
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
Less common
- Stomach pain