Active Ingredient: Nivolumab
Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A :
Intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B :
Intravenous, 480 milligrams nivolumab, once every 4 weeks.
The recommended dose of nivolumab is 240 mg every 2 weeks or 480 mg every 4 weeks administered intravenously over 30 minutes in combination with fluoropyrimidine- and platinum-based chemotherapy. Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or 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 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 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:
Regimen A :
Subcutaneous, 600 milligrams nivolumab, once every 2 weeks.
Regimen B :
Subcutaneous, 1,200 milligrams nivolumab, once every 4 weeks.
Recommended doses for administration of nivolumab solution for injection in combination with fluoropyrimidine- and platinum-based chemotherapy for the treatment of OSCC*:
| Combination therapy | |
| Nivolumab | 600 mg every 2 weeks or 1200 mg of nivolumab every 4 weeks |
| Fluoropyrimidine- and platinum- based chemotherapy | Every 4 weeks |
* Treatment with nivolumab is recommended until disease progression, unacceptable toxicity, or 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 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 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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