ZOLGENSMA is a one-time-only intravenous infusion1

Treat patients with systemic corticosteroids (equivalent to oral prednisolone at 1 mg/kg/day) 24 hours before ZOLGENSMA infusion. Continued corticosteroid treatment is required following infusion.

Clinical signs or symptoms of infection should not be evident at the time of ZOLGENSMA administration.

ZOLGENSMA is provided as a kit customized to meet the weight-based dosing requirements of each patient.

ZOLGENSMA is a suspension administered as a single intravenous infusion over 60 minutes. Insertion of a backup catheter prior to administration is recommended.

ZOLGENSMA packaging and vials

For single-dose intravenous infusion only1

Postpone infusion in patients with concurrent infections until the infection has resolved. Clinical signs or symptoms of infection should not be evident at the time of ZOLGENSMA administration. 

ZOLGENSMA is a suspension administered as an intravenous infusion over 60 minutes. A programmable syringe pump should be used to infuse the full volume of ZOLGENSMA. 

How ZOLGENSMA is supplied 

ZOLGENSMA Dosing And Kit Sizes

Patient Weight Range (kg)Dose Volumea (mL)Total Vials Per KitbNDC Numbers
2.6 – 3.016.5271894-120-02
3.1-3.519.3371894-121-03
3.6-4.022.0371894-122-03
4.1-4.524.8371894-123-03
4.6-5.027.5471894-124-04
5.1-5.530.3471894-125-04
5.6-6.033.0471894-126-04
6.1-6.535.8571894-127-05
6.6-7.038.5571894-128-05
7.1-7.541.3571894-129-05
7.6-8.044.0671894-130-06
8.1-8.546.8671894-131-06
8.6-9.049.5671894-132-06
9.1-9.552.3771894-133-07
9.6-10.055.0771894-134-07
10.1-10.557.8771894-135-07
10.6-11.060.5871894-136-08
11.1-11.563.3871894-137-08
11.6-12.066.0871894-138-08
12.1-12.568.8971894-139-09
12.6-13.071.5971894-140-09
13.1-13.5c74.3971894-141-09
NDC = National Drug Code. 
aDose volume is calculated using the upper limit of the patient weight range for pediatric patients less than 2 years of age between 2.6 kg and 13.5 kg. 
bAll vials have a nominal concentration of 2.0 × 1013 vector genomes (vg) per mL. Each vial of ZOLGENSMA contains an extractable volume of not less than either 5.5 mL or 8.3 mL. 
cDose volume for pediatric patients less than 2 years of age weighing equal to or greater than 13.6 kg will require a combination of ZOLGENSMA kits. 

Download the ZOLGENSMA Treatment Guide

Take an in-depth look at the steps to treatment and learn how to store, handle, and infuse ZOLGENSMA.

The recommended dose of ZOLGENSMA is 1.1 × 1014 vector genomes per kilogram (vg/kg) of body weight. Review the ZOLGENSMA Treatment Guide and the Full Prescribing Information for further dosing details.1

ZOLGENSMA Treatment Guide

The recommended dose of ZOLGENSMA is 1.1 × 1014 vector genomes per kilogram (vg/kg) of body weight.
Review the ZOLGENSMA Treatment Guide and the Full Prescribing Information for further dosing details.1

See the preparation, dosing, and infusion process for ZOLGENSMA

Systemic corticosteroid regimen1

To help manage a possible increase in liver aminotransferases following infusion with ZOLGENSMA, all patients should receive systemic corticosteroids prior to and following ZOLGENSMA infusion, as recommended:

The recommended treatment regimen is detailed in the Prescribing Information and in the accompanying chart.

If oral corticosteroid therapy is not tolerated, consider intravenous corticosteroids as clinically indicated.

Day 1: 24 hours before infusion

Initiate 30-day, systemic corticosteroid regimen equivalent to oral prednisolone at 1 mg/kg/day

Day 2: Infusion Day

Infuse ZOLGENSMA and continue the corticosteroid regimen

Day 30 & Beyond

Do not stop systemic corticosteroids abruptly

If liver function findings are unremarkable (including AST & ALT <2 x ULN)*:

 

  • Taper the corticosteroid dose gradually over the next 28 days

If liver function abnormalities persist*:

 

  • Continue systemic corticosteroids until AST & ALT values are both below 2 x ULN and all other assessments return to normal range, and then taper the dose gradually over the next 28 days or longer if needed
  • Consult a pediatric gastroenterologist or hepatologist

*Monitor liver function for at least 3 months following ZOLGENSMA infusion and until results are unremarkablea

ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.

aLiver function assessment includes a clinical exam and laboratory testing of hepatic aminotransferases (AST and ALT, total bilirubin, and prothrombin time). 

Before Treatment

Identifying eligible patients

Before Treatment

After Treatment

Essential post-infusion monitoring and management

After Treatment

Reference: 1. ZOLGENSMA [prescribing information]. Bannockburn, IL: Novartis Gene Therapies, Inc; 2022.