Prescription medicine
Onasemnogene abeparvovec Brand names: Zolgensma, Itvisma
Onasemnogene abeparvovec (Itvisma) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the onasemnogene abeparvovec FDA label on DailyMed (effective June 16, 2026); every onasemnogene abeparvovec label on DailyMed.
Highlights of the record
FDA label of June 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS LIVER.
INJURY and ACUTE LIVER FAILURE Cases of acute liver failure with fatal outcomes have been reported. Acute serious liver injury and elevated aminotransferases can also occur with ZOLGENSMA [see Warnings and Precautions ( 5.1 )]. Patients with preexisting liver impairment may be at higher risk [see Warnings and Precautions ( 5.1 )]. Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing. Administer systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion, and at other times as clinically indicated [see Dosage and Administration ( 2.1 , 2.3 )]. WARNING: SERIOUS LIVER INJURY and ACUTE LIVER FAILURE See full prescribing information for complete boxed warning. Cases of acute liver failure with fatal outcomes have been reported. Acute serious liver injury and elevated aminotransferases can also occur with ZOLGENSMA. ( 5.1 ) Patients with preexisting liver impairment may be at higher risk. ( 5.1 ) Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing. Administer systemic corticosteroid to all patients before and after ZOLGENSMA infusion. Continue to monitor liver function for at least 3 months after infusion, and at other times as clinically indicated.
Used for
From the label: indications and usageZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Forms and strengths
Kit; injection (suspension).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,272 through July 30, 2026
What is onasemnogene abeparvovec used for?
From the label: indications and usageZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Limitations of Use The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions ( 6.2 )]. The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies ( 14 )]. […]
Source: FDA drug label (Zolgensma), Novartis Innovative Technologies Inc., effective June 16, 2026 (SPL set 68cd4f06-70e1-40d8-bedb-609ec0afa471), via openFDA; the full label on DailyMed
Is there a generic for onasemnogene abeparvovec (Itvisma)?
No generic onasemnogene abeparvovec is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the onasemnogene abeparvovec label say about other medicines?
The onasemnogene abeparvovec label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Prednisone | drug interactions | Certain vaccines, such as measles, mumps, and rubella (MMR) and varicella, are contraindicated for patients on a substantially immunosuppressive steroid dose (i.e., ≥ 2 weeks of daily receipt of 20 mg or 2 mg/kg body weight of prednisone or equivalent). |
Source: FDA drug label (Zolgensma), Novartis Innovative Technologies Inc., effective June 16, 2026 (SPL set 68cd4f06-70e1-40d8-bedb-609ec0afa471), via openFDA; the full label on DailyMed
What do FAERS reports show for onasemnogene abeparvovec?
The FDA Adverse Event Reporting System holds 2,272 reports that list onasemnogene abeparvovec among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 157 are coded as a death and 726 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Onasemnogene abeparvovec side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other