Active Ingredient: Nivolumab
Nivolumab in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high colorectal cancer in the setting of first-line treatment of unresectable or metastatic colorectal cancer.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 12 weeks. Afterwards, intravenous, 240 milligrams nivolumab, once every 2 weeks.
Regimen B
Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 12 weeks. Afterwards, intravenous, 480 milligrams nivolumab, once every 4 weeks.
The recommended dose for first-line treatment of dMMR or MSI-H CRC is 240 mg of nivolumab in combination with 1 mg/kg ipilimumab administered intravenously every 3 weeks for a maximum of 4 doses, followed by nivolumab monotherapy administered intravenously at either 240 mg every 2 weeks or at 480 mg every 4 weeks. For the monotherapy phase, the first dose of nivolumab should be administered 3 weeks after the last dose of the combination of nivolumab and ipilimumab. 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. Dosing delay or discontinuation may be required based on individual safety and tolerability.
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.
For:
Regimen A
Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 15 weeks. Afterwards, subcutaneous, 600 milligrams nivolumab, once every 2 weeks.
Regimen B
Intravenous, 240 milligrams nivolumab, once every 3 weeks, 4 doses in total, over the duration of 15 weeks. Afterwards, subcutaneous, 1,200 milligrams nivolumab, once every 4 weeks.
Recommended doses and infusion times for nivolumab solution for infusion in combination with ipilimumab followed by nivolumab solution for injection monotherapy for dMMR or MSI-H CRC:
| Combination phase, nivolumab solution for infusion, intravenously (IV), and ipilimumab for 4 dosing cycles | Monotherapy phase nivolumab solution for injection, subcutaneously (SC) | ||
| Nivolumab | First-line treatment | 240 mg every 3 weeks over 30 minutes | 600 mg every 2 weeks or 1200 mg every 4 weeks The first dose should be administered 3 weeks after the last dose of the combination of IV nivolumab and ipilimumab. Treatment is recommended until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. |
| Ipilimumab | 1 mg/kg every 3 weeks over 30 minutes | - | |
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. Dosing delay or discontinuation may be required based on individual safety and tolerability.
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.
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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