Belantamab mafodotin

Source: UK SPC (eMC) §4.2 for Blenrep 100 mg powder for concentrate for solution for infusion (https://www.medicines.org.uk/emc/product/100782/smpc). VERBATIM (BVd): 'Blenrep is administered once every 3 weeks with a starting dose of 2.5 mg/kg.' SECOND REGIMEN — IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE (BPd): 30-minute infusion once every 4 weeks (28-day cycles) — starting dose 2.5 mg/kg given once in Cycle 1, then 1.9 mg/kg from Cycle 2 onwards. INDICATION: multiple myeloma; treatment should be initiated and monitored by physicians experienced in treating multiple myeloma. Refer to §5.1 or the relevant SmPCs for dosing of the combination agents. DOSE REDUCTION LEVELS — BVd (3-week cycle): starting 2.5 mg/kg every 3 weeks; reduced dose level 1 = 1.9 mg/kg every 3 weeks; no level 2. BPd (4-week cycle): starting 2.5 mg/kg once then 1.9 mg/kg every 4 weeks from Cycle 2; reduced dose level 1 = 1.9 mg/kg every 8 weeks; reduced dose level 2 = 1.4 mg/kg every 8 weeks. OCULAR SUPPORTIVE CARE AND MONITORING: an ophthalmic examination (visual acuity and slit lamp) by an eye care professional is required before each of the first 4 doses and as clinically indicated thereafter; advise preservative-free artificial tears at least 4 times a day from the first day of infusion until treatment completion; patients should avoid contact lenses until the end of treatment. Dose modification for ocular reactions is based on corneal examination findings and/or best corrected visual acuity in the most severely affected eye — Grade 1 continue at current dose; Grade 2 or 3 withhold until both corneal findings and BCVA improve to Grade 1 or better then resume at reduced dose level 1; Grade 4 (corneal epithelial defect, or BCVA worse than 20/200) withhold until improvement to Grade 1 or better then resume at reduced level 1 for BVd or level 2 for BPd, and consider permanent discontinuation for worsening symptoms unresponsive to reduction or withholding. DO NOT re-escalate the dose after a reduction made for ocular adverse reactions. If toxicity is identified before dosing Cycle 2 on the BPd regimen, dose at 1.9 mg/kg every 4 weeks. OTHER TOXICITY MODIFICATIONS: for Grade 3/4 thrombocytopenia, infusion-related reactions and other Grade 3/4 adverse reactions, the general pattern is to withhold and, for patients previously on 2.5 mg/kg, resume at 1.9 mg/kg (patients already on 1.9 mg/kg or lower resume at the same dose) — see §4.2 Table 4 in full. BODY WEIGHT: dosed on actual body weight; studied in patients weighing 37–170 kg. HEPATIC IMPAIRMENT: no adjustment in mild impairment; limited data in moderate impairment so dosing should be carefully considered; no data in severe impairment. ELDERLY: no dose adjustment for patients aged 65 years or over. PAEDIATRIC: safety and efficacy in children and adolescents under 18 years have not been established; no data are available. The eMC §4.4 and §4.8 text was truncated at the source-fetch limit; §4.5 interactions were not included in the fetched bundle.