Durvalumab

NO UK SPC WAS AVAILABLE IN THIS SOURCE BUNDLE - the whole entry is from the US IMFINZI prescribing information and must be verified against the UK SPC before publication. Indication-specific regimens for body weight 30 kg or more, exactly as stated in the US label: (1) Resectable NSCLC - neoadjuvant 1,500 mg with chemotherapy every 3 weeks for up to 4 cycles before surgery, adjuvant 1,500 mg single agent every 4 weeks for up to 12 cycles after surgery. (2) Unresectable Stage III NSCLC after concurrent platinum-based chemoradiation - 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks. (3) Metastatic NSCLC - 1,500 mg every 3 weeks with tremelimumab 75 mg and platinum-based chemotherapy for 4 cycles, then 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance every 4 weeks, plus a fifth dose of tremelimumab 75 mg with IMFINZI dose 6 at week 16. (4) Limited-stage SCLC after concurrent chemoradiation - 1,500 mg every 4 weeks. (5) Extensive-stage SCLC - 1,500 mg every 3 weeks with etoposide and carboplatin or cisplatin, then 1,500 mg every 4 weeks as a single agent. (6) Biliary tract cancer - 1,500 mg every 3 weeks with chemotherapy, then 1,500 mg every 4 weeks single agent. (7) Unresectable HCC - 1,500 mg with tremelimumab 300 mg as a single dose at Cycle 1 Day 1, then single agent every 4 weeks. (8) dMMR endometrial cancer - 1,120 mg with carboplatin and paclitaxel every 3 weeks for 6 cycles, then 1,500 mg every 4 weeks single agent. (9) NMIBC - 1,500 mg every 4 weeks for 13 cycles with BCG induction and maintenance. (10) MIBC - neoadjuvant 1,500 mg with gemcitabine and cisplatin every 3 weeks for 4 cycles before surgery, adjuvant 1,500 mg every 4 weeks for up to 8 cycles after surgery. (11) Resectable gastric/GOJ cancer - neoadjuvant 1,500 mg with FLOT every 4 weeks for up to 2 cycles before surgery, adjuvant 1,500 mg with FLOT every 4 weeks for up to 2 cycles then 1,500 mg single agent every 4 weeks for up to 10 cycles (total up to 12 cycles after surgery). For body weight under 30 kg the label substitutes weight-based dosing, most commonly 20 mg/kg on the same schedule (10 mg/kg every 2 weeks for unresectable Stage III NSCLC and for single-agent maintenance in extensive-stage SCLC; 15 mg/kg with carboplatin and paclitaxel in dMMR endometrial cancer, then 20 mg/kg every 4 weeks). This under-30 kg banding is a body-weight band in the adult label, not a paediatric indication - safety and effectiveness have not been established in paediatric patients. Dose modifications for adverse reactions are by withholding or permanent discontinuation (see full prescribing information); immune-mediated adverse reactions can occur in any organ system, and liver enzymes, creatinine and thyroid function should be evaluated at baseline and periodically. Infusion-related reactions: interrupt, slow the rate, or permanently discontinue based on severity. The detailed dosage table in the source was truncated at the fetch limit, so the durations and combination details above are the summary-level statements only.