Urothelial carcinoma

Active Ingredient: Nivolumab

Indication for Nivolumab

Population group: only adults (18 years old or older)

Therapeutic intent: Adjunct intent

Nivolumab in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

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

360 mg in combination with cisplatin and gemcitabine every 3 weeks for up to 6 cycles followed by nivolumab monotherapy at either 240 mg every 2 weeks or 480 mg every 4 weeks

For:

Dosage regimens

Regimen A: Intravenous, 360 milligrams nivolumab, once every 3 weeks. This step is repeated 6 times. Afterwards, intravenous, 240 milligrams nivolumab, once every 2 weeks.

Regimen B: Intravenous, 360 milligrams nivolumab, once every 3 weeks. This step is repeated 6 times. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.

Detailed description

The recommended dose is 360 mg nivolumab administered intravenously over 30 minutes in combination with cisplatin and gemcitabine every 3 weeks for up to 6 cycles followed by nivolumab monotherapy administered intravenously at either 240 mg every 2 weeks over 30 minutes or at 480 mg every 4 weeks over 30 minutes. Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or up to 24 months from first dose, whichever comes first.

Dosage considerations

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

Intravenous infusion over a period of 30 minutes.

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

Related medicines

Summary of Product Characteristics (SPC) 2024: OPDIVO Concentrate for solution for infusion

Develop a tailored medication plan for your case, considering factors such as age, gender, and health history

Ask the Reasoner

Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.