Cetuximab (Specialist drug)

NO UK SPC (eMC) WAS RETRIEVED IN THIS BUNDLE — the regimens above are taken from the US FDA prescribing information for ERBITUX (ImClone LLC; label date 2026-04-16; https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cd448bd-5230-450c-ad4c-359e6d54cd2b). VERBATIM (Highlights): 'In Combination With Radiation Therapy: Initial dose: 400 mg/m2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy. Subsequent doses: 250 mg/m2 administered as a 60-minute infusion every week for the duration of radiation therapy (6-7 weeks). Complete ERBITUX administration 1 hour prior to radiation therapy.' 'As Single-Agent or in Combination With Chemotherapy: Weekly: Administer initial dose of 400 mg/m2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m2 infused over 60 minutes once weekly. Biweekly: Administer 500 mg/m2 as a 120-minute intravenous infusion every two weeks. Complete ERBITUX administration 1 hour prior to chemotherapy. Continue treatment until disease progression or unacceptable toxicity.' BY INDICATION: SCCHN (§2.2) — with radiotherapy as above, or as a single agent or with platinum-based therapy and fluorouracil on the weekly or biweekly schedule; colorectal cancer (§2.3) — as a single agent or with irinotecan or FOLFIRI (irinotecan, fluorouracil, leucovorin) on the weekly or biweekly schedule; with encorafenib (BRAF V600E mCRC) — initial 400 mg/m2 over 120 minutes then 250 mg/m2 weekly over 60 minutes until disease progression or unacceptable toxicity (refer to the encorafenib prescribing information for its dose). PATIENT SELECTION (§2.1): select patients with metastatic CRC based on Ras wild-type, EGFR-expressing CRC, or BRAF V600E mutation-positive metastatic CRC. PREMEDICATION (§2.4): 'Premedicate with a histamine-1 (H1) receptor antagonist intravenously 30-60 minutes prior to the first dose or subsequent doses as deemed necessary.' DOSE MODIFICATIONS (§2.5, Table 1): infusion reactions Grade 1 or 2 — reduce the infusion rate by 50%; Grade 3 or 4 — immediately and permanently discontinue. Dermatologic toxicity and infectious sequelae Grade 3 or 4 — delay the infusion 1 to 2 weeks and, if the condition improves, continue at 250 mg/m2 (1st occurrence), 200 mg/m2 (2nd occurrence) or 150 mg/m2 (3rd occurrence); discontinue at the 4th occurrence or if there is no improvement. Pulmonary toxicity — delay 1 to 2 weeks; if it improves continue at the dose being given at the time of occurrence; discontinue if there is no improvement in 2 weeks or ILD is confirmed. PAEDIATRIC (§8.4): 'The safety and effectiveness of ERBITUX in pediatric patients have not been established.' Pharmacokinetics were evaluated in an open-label, single-arm, dose-finding study at doses UP TO 250 mg/m2 once weekly in 27 patients aged 1 to 12 years and 19 patients aged 13 to 18 years, with no new safety signals — THIS IS NOT AN APPROVED PAEDIATRIC REGIMEN and must not be used as a paediatric dose; paedDose is therefore null. Verify any under-18 use against a children's formulary. ELDERLY (§8.5): no overall differences in safety or efficacy were observed between patients 65 years or older and younger patients in colorectal cancer; head and neck studies did not include sufficient numbers of subjects aged 65 and over. NO §7 DRUG INTERACTIONS SECTION AND NO RENAL DOSING SECTION WERE RETRIEVED IN THIS BUNDLE. Several sections of the fetched US label were truncated at the source-fetch limit — clinician to confirm against the full label and the UK SPC before publication.