Active Ingredient: Nivolumab
Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 360 milligrams nivolumab, once every 3 weeks.
The recommended dose is 360 mg nivolumab every 3 weeks in combination with 1 mg/kg ipilimumab every 6 weeks. Treatment is continued for up to 24 months in patients without disease progression.
Treatment with nivolumab, either as a monotherapy or in combination with other therapeutic agents, should be continued as long as clinical benefit is observed or until treatment is no longer tolerated by the patient (and up to maximum duration of therapy if specified for an indication).
Atypical responses (i.e., an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. It is recommended to continue treatment with nivolumab or nivolumab in combination with ipilimumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability.
Nivolumab as monotherapy or in combination with other therapeutic agents should be permanently discontinued for:
When nivolumab is administered intravenously in combination with ipilimumab, if either agent is withheld, the other agent should also be withheld. If dosing is resumed after a delay, either the intravenous combination treatment or nivolumab monotherapy administered intravenously or subcutaneously could be resumed based on the evaluation of the individual patient.
When administered in combination with ipilimumab, nivolumab should be given first followed by ipilimumab (if applicable) and then by chemotherapy on the same day. Use separate infusion bags and filters for each infusion.
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