Nivolumab (Specialist drug)

Treatment must be initiated and supervised by physicians experienced in the treatment of cancer. Indication-specific monotherapy schedules (SPC Table 1): advanced or adjuvant melanoma, renal cell carcinoma and adjuvant muscle-invasive urothelial carcinoma - 240 mg every 2 weeks over 30 minutes or 480 mg every 4 weeks over 60 minutes (or over 30 minutes for adjuvant melanoma); adjuvant oesophageal or gastro-oesophageal junction cancer - 240 mg every 2 weeks over 30 minutes, or 480 mg every 4 weeks over 30 minutes for the first 16 weeks then 480 mg every 4 weeks over 30 minutes; locally advanced or metastatic NSCLC, classical Hodgkin lymphoma, squamous cell cancer of head and neck, urothelial carcinoma and oesophageal squamous cell carcinoma - 240 mg every 2 weeks over 30 minutes. For adjuvant therapy the maximum treatment duration is 12 months. Switching schedules: the first 480 mg dose is given 2 weeks after the last 240 mg dose; the first 240 mg dose is given 4 weeks after the last 480 mg dose. COMBINATION REGIMENS (all IV over 30 minutes unless stated): with ipilimumab for melanoma - nivolumab 1 mg/kg every 3 weeks for 4 cycles with ipilimumab 3 mg/kg every 3 weeks, then nivolumab monotherapy; malignant pleural mesothelioma - nivolumab 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks for up to 24 months; RCC - nivolumab 3 mg/kg every 3 weeks for 4 cycles with ipilimumab 1 mg/kg every 3 weeks, then monotherapy; dMMR/MSI-H colorectal cancer first line - nivolumab 240 mg every 3 weeks with ipilimumab 1 mg/kg every 3 weeks for up to 4 cycles, then monotherapy (after prior fluoropyrimidine-based chemotherapy, nivolumab 3 mg/kg every 3 weeks); oesophageal squamous cell carcinoma - nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks; hepatocellular carcinoma - nivolumab 1 mg/kg every 3 weeks with ipilimumab 3 mg/kg every 3 weeks for up to 4 cycles, then monotherapy; with cabozantinib for RCC - nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks plus cabozantinib 40 mg once daily orally; NSCLC with ipilimumab and platinum chemotherapy - nivolumab 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks; neoadjuvant NSCLC with platinum chemotherapy - nivolumab 360 mg every 3 weeks for 3 cycles (or up to 4 cycles neoadjuvant followed by 480 mg every 4 weeks adjuvant for up to 13 cycles); OSCC with fluoropyrimidine- and platinum-based chemotherapy - 240 mg every 2 weeks or 480 mg every 4 weeks; gastric/GEJ/oesophageal adenocarcinoma with chemotherapy - 360 mg every 3 weeks or 240 mg every 2 weeks; urothelial carcinoma with cisplatin and gemcitabine - 360 mg every 3 weeks for up to 6 cycles, then monotherapy. Dose escalation or reduction is NOT recommended; dosing delay or discontinuation may be required based on safety and tolerability (SPC Table 15). Many combination regimens are capped at up to 24 months in patients without disease progression. NOTE: the fetched SPC posology section was truncated at the source-fetch limit part-way through the special-populations text - the clinician must confirm the complete posology, including any regimens beyond that point, against the current SPC.

Applies only to adolescents 12 years of age and older weighing LESS than 50 kg, for advanced or adjuvant melanoma, renal cell carcinoma and adjuvant muscle-invasive urothelial carcinoma. Adolescents 12 years and older weighing at least 50 kg receive the adult flat dose (240 mg every 2 weeks or 480 mg every 4 weeks). In the melanoma combination regimen, nivolumab 1 mg/kg every 3 weeks applies to adults and adolescents 12 years and older regardless of weight, with the monotherapy phase then weight-banded as above. Verify against a children's formulary and current SPC before prescribing.