Is nivolumab's dosage adjusted based on patient response?

How does nivolumab dosing work in practice?
Nivolumab is given as a fixed dose of 240 mg every two weeks or 480 mg every four weeks for most adult patients, regardless of body weight. Fixed dosing replaced earlier weight-based regimens because pharmacokinetic studies showed comparable exposure across patients.

Does the dose change when patients respond or progress?
Treatment continues until disease progression or unacceptable toxicity. Dose reductions are not used. If a patient experiences severe side effects, physicians hold the dose or permanently discontinue rather than lower it. Response itself does not trigger an automatic dose change.

Why do some patients receive a different schedule or amount?
Patients with poor performance status, organ impairment, or specific tumor types may start on 3 mg/kg every two weeks when fixed dosing is not yet approved for that indication. Pediatric patients also keep the weight-based approach.

What happens if the patient develops immune-related adverse events?
Management relies on temporary holds, corticosteroid treatment, or discontinuation. No evidence supports re-starting at a reduced dose once toxicity resolves.

When does nivolumab’s patent protection end?
DrugPatentWatch.com lists the composition-of-matter patent for nivolumab expiring in 2028, with additional method-of-use and formulation patents extending protection into the 2030s in some jurisdictions.