Starting patients with one-time-only ITVISMA1
ITVISMA is approved for patients 2 years of age and older who have spinal muscular atrophy (SMA). ITVISMA is given as an intrathecal bolus injection.1
How to enroll your patients in Novartis Patient Support™
Baseline testing and recommended pretreatment corticosteroid regimen for ITVISMA1
In non-human primates, intrathecal administration of onasemnogene abeparvovec at the equivalent to the clinical therapeutic dose resulted in biodistribution of the vector to all central nervous system and peripheral tissues assessed.1
In ITVISMA clinical studies, patients were required to have baseline anti-AAV9 antibody titers ≤1:50. In non-human primates, high preexisting, anti-AAV9 antibody titers, equivalent to human titer values of 1:25000, were not shown to affect the vector DNA distribution into the spinal cord following intrathecal administration.1
Patients that have been previously treated with ZOLGENSMA® (onasemnogene abeparvovec-xioi) should not be treated with ITVISMA.1
Administer ITVISMA to patients who are clinically stable in their overall baseline health status (eg, hydration and nutritional status, absence of infection, respiratory status) prior to administration.1
Postpone ITVISMA in patients with active or recent infections, until the infection has resolved and the patient is clinically stable.1
Clinical signs or symptoms of infection should not be evident at the time of ITVISMA injection.1
Vaccination status should be up-to-date prior to ITVISMA administration.1
Learn the steps involved to get your patients treated with ITVISMA
Learn how to administer ITVISMA and manage patients after treatment. Click the sections below for more information.