Ipilimumab (Specialist drug)

SCOPE: the dose field carries the page's PRIMARY indication — unresectable or metastatic melanoma, treated with single-agent ipilimumab, intravenously — which is also the first indication in this label. Every other regimen in the fetched label is listed verbatim below; none of them has been used to fill the dose field. The page itself is flagged 'Specialist initiation only' and that remains true: ipilimumab is given inside an oncology protocol, not from a dose lookup. || WHY maxDose IS EMPTY: the only 'maximum' cue in this label is a maximum NUMBER OF DOSES ('for a maximum of 4 doses'), which is a course limit, not a dose ceiling; and every dose figure in the label is a per-kilogram value, which cannot go in this field. Both are carried in the dose and frequency fields instead. || ALL REGIMENS, VERBATIM (§2 Dosage and Administration). Unresectable or Metastatic Melanoma: 'YERVOY 3 mg/kg every 3 weeks for a maximum of 4 doses' and 'YERVOY 3 mg/kg immediately following nivolumab 1 mg/kg on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer nivolumab as a single agent as recommended in the Full Prescribing Information for nivolumab.' Adjuvant Treatment of Melanoma: 'YERVOY 3 mg/kg every 3 weeks for 4 doses, followed by 3 mg/kg every 12 weeks for up to 4 additional doses.' Advanced Renal Cell Carcinoma: 'YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day, every 3 weeks for 4 doses. After completing 4 doses of the combination, administer nivolumab as a single agent...' MSI-H or dMMR colorectal cancer, in combination with nivolumab: 'Adult and pediatric patients weighing 40 kg or greater: YERVOY 1 mg/kg immediately following nivolumab 240 mg on the same day every 3 weeks for a maximum of 4 doses... Pediatric patients weighing less than 40 kg: YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day every 3 weeks for a maximum of 4 doses.' Hepatocellular Carcinoma: 'YERVOY 3 mg/kg intravenously over 30 minutes immediately following nivolumab 1 mg/kg intravenously over 30 minutes on the same day, every 3 weeks for up to 4 doses.' Metastatic non-small cell lung cancer: 'YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks' or 'YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks and 2 cycles of platinum-doublet chemotherapy.' Malignant pleural mesothelioma: 'YERVOY 1 mg/kg every 6 weeks with nivolumab 360 mg every 3 weeks.' Esophageal squamous cell carcinoma: 'YERVOY 1 mg/kg every 6 weeks with nivolumab 3 mg/kg every 2 weeks or 360 mg every 3 weeks.' || PATIENT SELECTION (§2.1): for metastatic NSCLC, 'Select patients... for treatment with YERVOY in combination with nivolumab based on PD-L1 expression'; FDA-authorised tests are used for patient selection. || DOSAGE MODIFICATIONS: the label repeatedly cross-refers to §2.3 for modifications for adverse reactions; that section was NOT retrieved in this bundle. The principle stated in §5.1 is: 'In general, withhold YERVOY for severe (grade 3) and permanently discontinue for life-threatening (grade 4) immune-mediated adverse reactions.' For infusion-related reactions (§5.2): 'Discontinue for severe and life-threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion-related reactions.' || STRENGTHS (§3, verbatim): 'Injection: 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) as a clear to slightly opalescent, colorless to pale-yellow solution in a single-dose vial.'

WHY dosePerKg IS NULL: there is no single per-kg per-dose figure valid across the paediatric range. Paediatric use is established only from 12 years of age, and the per-kg figure differs by indication (3 mg/kg for melanoma, 1 mg/kg in the nivolumab combinations). Nothing here should feed a weight calculator; this is a specialist protocol drug. || AGE LIMITS, verbatim (§8.4 Pediatric Use): 'The safety and effectiveness of YERVOY have been established in pediatric patients aged 12 years and older for the following indications: as a single agent and in combination with nivolumab for unresectable or metastatic melanoma, in combination with nivolumab for the treatment of MSI-H or dMMR unresectable and metastatic CRC, and in combination with nivolumab for MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Use of YERVOY for these indications is supported by evidence from adequate and well-controlled studies in adults with melanoma or MSI-H or dMMR mCRC and additional pharmacokinetic data in pediatric patients. Ipilimumab exposures in pediatric patients 12 years and older are comparable to that of adults... The safety and effectiveness of YERVOY have not been established in pediatric patients younger than 12 years old with unresectable or metastatic melanoma or MSI-H or dMMR mCRC. The safety and effectiveness of YERVOY have not been established in pediatric patients for the adjuvant treatment of melanoma or for the treatment of' — the section is TRUNCATED AT THE SOURCE-FETCH LIMIT at this point, so the full list of indications not established in children was not retrieved. || THE ONLY EXPLICITLY WEIGHT-BANDED PAEDIATRIC RULE IN THE LABEL (MSI-H or dMMR colorectal cancer with nivolumab, §2.2, verbatim): 'Adult and pediatric patients weighing 40 kg or greater: YERVOY 1 mg/kg immediately following nivolumab 240 mg on the same day every 3 weeks for a maximum of 4 doses. After completing the combination, administer nivolumab as a single agent... Pediatric patients weighing less than 40 kg: YERVOY 1 mg/kg immediately following nivolumab 3 mg/kg on the same day every 3 weeks for a maximum of 4 doses.' Note that the ipilimumab dose is the same in both bands (1 mg/kg); it is the nivolumab component that is weight-banded. || The melanoma regimens are not age-restricted in §2.2, so the adult single-agent regimen (3 mg/kg every 3 weeks for a maximum of 4 doses) is the one that applies from 12 years for that indication — but this is an oncology protocol drug and the dose must come from the treating protocol, not from this page. Verify any under-18 use against a children's formulary and the treating centre's protocol. || CONCENTRATION: 5 mg/mL, pinned by §3 ('50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL)'); this is the vial strength before the dilution required by §2.