Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer

The recommended dose of nivolumab is either 240 mg every 2 weeks or 480 mg every 4 weeks.

If patients need to be switched from the 240 mg every 2 weeks schedule to the 480 mg every 4 weeks schedule, the first 480 mg dose should be administered two weeks after the last 240 mg dose. Conversely, if patients need to be switched from the 480 mg every 4 weeks schedule to the 240 mg every 2 weeks schedule, the first 240 mg dose should be administered four weeks after the last 480 mg dose.

Duration of treatment

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:

• Grade 4 or recurrent Grade 3 adverse reactions;
• Persistent Grade 2 or 3 adverse reactions despite management.

If dosing is resumed after a delay, monotherapy could be resumed based on the evaluation of the individual patient.

The recommended dose of nivolumab solution for injection is either nivolumab 600 mg every 2 weeks or 1200 mg every 4 weeks.

If patients need to be switched from the 600 mg every 2 weeks schedule to the 1200 mg every 4 weeks schedule, the first 1200 mg dose should be administered two weeks after the last 600 mg dose. Conversely, if patients need to be switched from the 1200 mg every 4 weeks schedule to the 600 mg every 2 weeks schedule, the first 600 mg dose should be administered four weeks after the last 1200 mg dose.

Duration of treatment

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:

• Grade 4 or recurrent Grade 3 adverse reactions;
• Persistent Grade 2 or 3 adverse reactions despite management.

If dosing is resumed after a delay, monotherapy 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.