Adjuvant treatment of muscle invasive urothelial carcinoma

Active Ingredient: Nivolumab

Indication for Nivolumab

Population group: only adults (18 years old or older)
Therapeutic intent: Adjuvant - intent

Nivolumab as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC.

For this indication, competent medicine agencies globally authorize below treatments:

240 mg every 2 weeks or 480 mg every 4 weeks

For:

Dosage regimens

Regimen A: Intravenous, 240 milligrams nivolumab, once every 2 weeks.

Regimen B: Intravenous, 480 milligrams nivolumab, once every 4 weeks.

Detailed description

240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes.

If patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 240 mg dose. Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.

Dosage considerations

Nivolumab must not be administered as an intravenous push or bolus injection.

Active ingredient

Nivolumab

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2. Nivolumab potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands. In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.

Read more about Nivolumab

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