Patient management post administration
Corticosteroid regimen
The table below includes the recommended corticosteroid regimen prior to and following ITVISMA injection.1
If at any time patients do not respond adequately to the equivalent of 1 mg/kg/day oral prednisolone, based on the patient’s clinical course, obtain prompt consultation with a gastroenterologist or hepatologist and consider adjustment to the recommended corticosteroid regimen, including increased dose, longer duration, or prolongation of corticosteroid taper.1
If oral corticosteroid therapy is not tolerated or not effective, consider intravenous corticosteroids, as clinically indicated.1
Recommended corticosteroid regimen prior and post ITVISMA injection1 | ||
| Pre-injection | 24 hours prior to ITVISMA injection | Oral prednisolone 1 mg/kg/day (or equivalent) |
| Post-injection | 30 days (including the day of ITVISMA administration) | Oral prednisolone 1 mg/kg/day (or equivalent) |
Followed by 28 days: For patients with unremarkable findings (normal clinical exam, total bilirubin, and ALT and AST levels below 2 × ULN) For patients with liver function abnormalities at the end of the 30-day period: continue until the AST and ALT values are both below 2 × ULN and all other assessments return to normal range, and then taper the corticosteroid dose over the next 28 days or longer if needed | Systemic corticosteroids should be tapered gradually
Systemic corticosteroids (equivalent to oral prednisolone 1 mg/kg/day) | |
Liver function
Monitor liver function (ALT, AST, total bilirubin) for at least 3 months following ITVISMA injection, and at other times as clinically indicated. Promptly assess and closely monitor patients with worsening liver function test results and/or signs or symptoms of acute illness.1
Interested in integrating ITVISMA into your center?
A wide range of resources are available to help get you started.
Novartis provides training and logistical support to help institutions prepare to administer ITVISMA. For more information, connect with a Regional Accounts Associate Director, or RAAD.
Learn the steps involved to get your patients treated with ITVISMA
Revisit pretreatment steps and administration guidance to support ongoing patient management after treatment. Click the sections below for more information.