WHY SPINRAZA/SAFETY PROFILE
Safety & side effects
The safety and efficacy of SPINRAZA was evaluated in the longest clinical trial program in SMA to date
Blood and urine testing
Because an increased risk of bleeding
and kidney damage has been seen in
similar medications, individuals taking
SPINRAZA may be at similar risk.
It is recommended that your
healthcare provider (HCP) perform
blood and urine testing once before
treatment and again before each dose
to monitor for signs of these risks.
Common side effects
In clinical studies, the most common
side effects of SPINRAZA included
lower respiratory infection, fever,
constipation, headache, vomiting,
back pain, and post-lumbar puncture
syndrome (headache related to the
intrathecal procedure).
The most common side effects of SPINRAZA in the Low Dose Regimen in infantile- and later-onset SMA include lower respiratory infection, constipation, fever, headache, vomiting, back pain, and post-lumbar puncture syndrome.
The most common side effects of SPINRAZA in the High Dose Regimen in infantile-onset SMA include pneumonia, COVID-19, pneumonia aspiration, and malnutrition. COVID-19 was not discovered at the time of the studies for the Low Dose Regimen.
