Onasemnogene abeparvovec-xioi (Intravenous)
Medically reviewed by Drugs.com. Last updated on Apr 26, 2022.
Acute Serious Liver Injury and Acute Liver Failure: Acute serious liver injury, acute liver failure, and elevated aminotransferases can occur with onasemnogene abeparvovec-xioi. Patients with preexisting liver impairment may be at higher risk. Prior to infusion, assess liver function of all patients by clinical examination and laboratory testing (eg, hepatic aminotransferases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], total bilirubin, and prothrombin time). Administer systemic corticosteroid to all patients before and after onasemnogene abeparvovec-xioi infusion. Continue to monitor liver function for at least 3 months after infusion .
Commonly used brand name(s)
In the U.S.
- Zolgensma
Available Dosage Forms:
- Suspension
Therapeutic Class: Musculoskeletal Agent
Uses for onasemnogene abeparvovec-xioi
Onasemnogene abeparvovec-xioi injection is used to treat spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Spinal muscular atrophy is a rare neuromuscular disorder that is characterized by loss of lower motor neurons and progressive muscle wasting, often leading to early death. Onasemnogene abeparvovec-xioi is an adeno-associated virus vector-based gene treatment that works by copying the gene needed for the human SMN protein.
Onasemnogene abeparvovec-xioi is to be given only by or under the direct supervision of your doctor.
Before using onasemnogene abeparvovec-xioi
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For onasemnogene abeparvovec-xioi, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to onasemnogene abeparvovec-xioi or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onasemnogene abeparvovec-xioi injection in newborns to children younger than 2 years of age. However, use is not recommended in premature infants. Safety and efficacy have been established.
Geriatric
No information is available on the relationship of age to the effects of onasemnogene abeparvovec-xioi injection in geriatric patients.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (o..
