Active Ingredient: Nivolumab
Nivolumab in combination with brentuximab vedotin is indicated for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that patient age in years is ≥ 5 and patient age in years is ≤ 30 :
Intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 3 weeks.
Recommended doses and infusion times for intravenous administration of nivolumab in combination with brentuximab vedotin for relapsed or refractory cHL:
| Combination therapy* | |
| Nivolumab | 3 mg/kg every 3 weeks over 30 minutes For Cycle 1 only, nivolumab should be administered on Day 8 of the cycle. For Cycles 2-6, nivolumab should be administered 30 minutes after completion of brentuximab vedotin administration, on the same day. |
| Brentuximab Vedotin | 1.8 mg/kg up to a maximum of 180 mg, every 3 weeks over 30 minutes For Cycles 1-6, brentuximab vedotin should be administered on Day 1 of the Cycle. |
* Treatment is risk-based, response-adapted.
Patients should have tumour assessment after every 2 cycles and discontinue treatment in case of progressive disease at any point of assessment:
In case of sub-optimal response to 4 cycles of the combination treatment, patients should receive intensification therapy prior to proceeding to consolidation therapy once complete response is achieved.
Treatment with nivolumab 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.
Dose escalation or reduction is not recommended for nivolumab in combination with other therapeutic agents. Dosing delay or discontinuation may be required based on individual safety and tolerability.
Nivolumab in combination with other therapeutic agents should be permanently discontinued for:
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