The safety of ITVISMA was evaluated in two studies
The safety profile of ITVISMA was studied in people new to treatment and in people who stopped their previous treatment.
Across 2 clinical studies, ITVISMA has been studied in 153 people living with spinal muscular atrophy (SMA).* At the time of administration, ages ranged from 2 to <18 years old.
The most frequently experienced adverse reactions (adverse reactions seen in ≥2% of people or were more common with ITVISMA compared to the sham-control group) in the main study were upper respiratory tract infection, fever, stomach-related symptoms, elevated liver enzymes, headache, dizziness, limb pain, low blood platelet count, and sensory disturbance.
When safety was evaluated in people who changed to ITVISMA from either SPINRAZA® (nusinersen) or EVRYSDI® (risdiplam) no additional safety events were found. Other side effects may be possible. For more information on the safety profile of ITVISMA, please reach out to your doctor.
After you receive your dose, your doctor will monitor you closely.†
*The safety data described in this section includes ITVISMA in 2 clinical studies: STEER, a randomized, sham-controlled study, which evaluated the safety of ITVISMA in 126 patients with SMA, and STRENGTH, an open-label, single-arm study, which evaluated the safety of ITVISMA in 27 patients with SMA who were previously treated with nusinersen (at least 4 months washout) or risdiplam (at least 15 days washout).
†People with SMA should continue to see their neurologist and other specialists as needed.
EVRYSDI® is a registered trademark of Genentech USA, Inc.
SPINRAZA® is a registered trademark of Biogen.