Active Ingredient: Nivolumab
Nivolumab, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by nivolumab as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 360 milligrams nivolumab, once every 3 weeks. This step is repeated 4 times. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks. This step is repeated 1 to 13 times.
The recommended dose is 360 mg nivolumab administered intravenously over 30 minutes in combination with platinum-based chemotherapy every 3 weeks for 4 cycles in the neoadjuvant phase, followed by adjuvant treatment with nivolumab 480 mg as monotherapy every 4 weeks. Treatment is recommended until disease progression or recurrence, unacceptable toxicity, or up to 13 cycles.
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).
For adjuvant therapy, the maximum treatment duration with nivolumab is 12 months.
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 for nivolumab as monotherapy or in combination with other therapeutic agents. Dosing delay or discontinuation may be required based on individual safety and tolerability. When nivolumab is administered in combination with other therapeutic agents, refer to the SmPC of these other combination therapeutic agents regarding dosing.
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 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, either the combination treatment, nivolumab monotherapy or chemotherapy alone could be resumed based on the evaluation of the individual patient.
When administered in combination with chemotherapy, nivolumab should be given first followed by chemotherapy on the same day. Use separate infusion bags and filters for each infusion.
For:
Intravenous, 360 milligrams nivolumab, once every 3 weeks. This step is repeated 4 times. Afterwards, subcutaneous, 1,200 milligrams nivolumab, once every 4 weeks. This step is repeated 1 to 13 times.
Recommended doses and infusion times for nivolumab solution for infusion in combination with platinum-based chemotherapy for neoadjuvant treatment followed by nivolumab solution for injection monotherapy for adjuvant treatment of NSCLC:
| Combination phase Neoadjuvant treatment nivolumab solution for infusion, intravenously (IV) with chemotherapy for 4 cycles | Monotherapy phase* Adjuvant treatment nivolumab solution for injection, subcutaneously (SC) | |
| Nivolumab | 360 mg every 3 weeks over 30 minutes | 1200 mg every 4 weeks |
| Platinum-based chemotherapy | Every 3 weeks | - |
* Treatment is recommended until disease progression or recurrence, unacceptable toxicity, or up to 13 cycles.
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).
For adjuvant therapy, the maximum treatment duration with nivolumab is 12 months.
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 for nivolumab as monotherapy or in combination with other therapeutic agents. Dosing delay or discontinuation may be required based on individual safety and tolerability. When nivolumab is administered in combination with other therapeutic agents, refer to the SmPC of these other combination therapeutic agents regarding dosing.
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 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, either the combination treatment, nivolumab monotherapy or chemotherapy alone could be resumed based on the evaluation of the individual patient.
Administer the full contents of the syringe of nivolumab solution for injection into the subcutaneous tissue of the abdomen or thigh over a period of 3 to 5 minutes. The dose should not be split between two syringes or between two sites of administration. Alternate injection sites for successive injections. Do not inject into areas where the skin is tender, red, or bruised, or areas where there are scars or moles. If the administration of nivolumab solution for injection is interrupted, it can be resumed at the same site, or at an alternate site.
During the treatment course with nivolumab solution for injection, other medicinal products for subcutaneous administration should preferably be injected at different sites.
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