Onasemnogene abeparvovec Zolgensma

Generic name: Onasemnogene Abeparvovec (Zolgensma)
Dosage form: intravenous kit (xioi 20 trillion vg/mL)
Drug class: Miscellaneous uncategorized agents

Usage of Onasemnogene abeparvovec Zolgensma

Onasemnogene abeparvovec is used to treat spinal muscular atrophy in children younger than 2 years old who have a specific gene mutation that affects nerve signals to the muscles.

onasemnogene abeparvovec may not be effective in a child who is completely paralyzed or is Dependent on a ventilator for breathing.

Onasemnogene abeparvovec may also be used for purposes not listed in this medication guide.

Onasemnogene abeparvovec Zolgensma side effects

Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has:

jaundice (yellowing of the skin or eyes); or

easy bruising, unusual bleeding, purple or red spots under your skin.

Common side effects of onasemnogene abeparvovec may include:

vomiting; or

abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Onasemnogene abeparvovec Zolgensma

This medicine can cause serious liver damage. Tell your doctor if your child has ever had liver problems.

It may not be safe to breastfeed your child while he or she is receiving this medicine. Ask your doctor about any risk.

Relate drugs

How to use Onasemnogene abeparvovec Zolgensma

Usual Pediatric Dose for Spinal Muscular Atrophy:

Prior to infusion: -Assess liver function by clinical examination and laboratory testing (ALT, AST, total bilirubin, and prothrombin time)-Obtain creatinine, complete blood count (including hemoglobin and platelet counts), and troponin-I-Assess for the presence of anti-AAV9 antibodiesCorticosteroid -Initiate systemic corticosteroids 1 day prior to IV infusion and continue for a total of 30 days (equivalent to oral prednisolone 1 mg/kg/day) Single-dose: 1.1 x 10(14) vector genomes/kg IV through a venous catheter over 60 minutes Comments:-See Other comments/Administration advice for guidance on administration; the manufacturer's product labeling provides a dose table which includes dose volume (mL) based on weight. -The use in patients with advance spinal muscular atrophy (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated. -The safety and effectiveness of repeat administration have not been evaluated. Use: For the treatment of patients less than 2 years with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene; because concomitant treatment with corticosteroids may adversely affect neurological development, infusion should be delayed until corresponding full-term gestational age is reached.

Warnings

onasemnogene abeparvovec can cause serious liver damage, especially in children who already have liver problems. Your doctor will perform blood tests to make sure your child does not have conditions that would make it unsafe to receive onasemnogene abeparvovec.

What other drugs will affect Onasemnogene abeparvovec Zolgensma

Other drugs may affect onasemnogene abeparvovec, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your child's current medicines and any medicine the child starts or stops using.

Disclaimer

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