Active Ingredient: Nivolumab
Nivolumab in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A, in the case that patient weight is ≥ 80 kg :
Intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B, in the case that patient weight is < 80 kg :
Intravenous, 3 milligrams nivolumab per kilogram of body weight, once every 2 weeks.
Recommended doses and infusion times for intravenous administration of nivolumab in combination with AVD chemotherapy for previously untreated cHL:
| Combination phase for 6 dosing cycles* | ||
| Nivolumab | Adolescents (12 years of age and older weighing at least 80 kg) | 240 mg every 2 weeks over 30 minutes |
| Nivolumab | Adolescents (12 years of age and older weighing less than 80 kg) | 3 mg/kg every 2 weeks over 30 minutes |
| Doxorubicin, vinblastine and dacarbazine (AVD) | Every 2 weeks |
* One dosing cycle of nivolumab in combination with AVD is 28 days
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. It is recommended to continue treatment with nivolumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended for nivolumab. Dosing delay or discontinuation may be required based on individual safety and tolerability.
Nivolumab should be permanently discontinued for:
If dosing is resumed after a delay, monotherapy could be resumed based on the evaluation of the individual patient.
When nivolumab is administered in combination with chemotherapy, refer to the SmPC of the other combination therapy agents regarding dosing. If any agents are withheld, the other agents may be continued. If dosing is resumed after a delay, chemotherapy alone could be resumed based on the evaluation of the individual patient.
For:
Intravenous, 240 milligrams nivolumab, once every 2 weeks.
Recommended doses and infusion times for intravenous administration of nivolumab in combination with AVD chemotherapy for previously untreated cHL:
| Combination phase for 6 dosing cycles* | ||
| Nivolumab | Adults | 240 mg every 2 weeks over 30 minutes |
| Doxorubicin, vinblastine and dacarbazine (AVD) | Every 2 weeks |
* One dosing cycle of nivolumab in combination with AVD is 28 days
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. It is recommended to continue treatment with nivolumab for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Dose escalation or reduction is not recommended for nivolumab. Dosing delay or discontinuation may be required based on individual safety and tolerability.
Nivolumab should be permanently discontinued for:
If dosing is resumed after a delay, monotherapy could be resumed based on the evaluation of the individual patient.
When nivolumab is administered in combination with chemotherapy, refer to the SmPC of the other combination therapy agents regarding dosing. If any agents are withheld, the other agents may be continued. If dosing is resumed after a delay, chemotherapy alone could be resumed based on the evaluation of the individual patient.
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