Mogamulizumab (Specialist drug)

SOURCE: US FDA prescribing information only (POTELIGEO, Kyowa Kirin Inc., label date 2026-03-02, https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2002b8eb-c6a6-4f3f-8a58-963fe6c015c4). NO UK SPC was fetched in this bundle — the eMC provider is null — so this is US labelling and must be verified against a UK SPC before use. Verbatim: 'The recommended dose of POTELIGEO is 1 mg/kg administered as an intravenous infusion over at least 60 minutes. Administer on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.' TIMING: administer within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume the dosing schedule. PREMEDICATION: administer premedication with diphenhydramine and an antipyretic (the US label names acetaminophen, i.e. paracetamol) for the FIRST infusion. If an infusion reaction occurs, administer premedication for subsequent infusions. DOSE MODIFICATION — DERMATOLOGIC TOXICITY: permanently discontinue for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN); if SJS or TEN is suspected, stop and do not resume unless SJS/TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less; for moderate or severe (Grade 2 or 3) rash, interrupt and give at least 2 weeks of topical corticosteroids, resuming if the rash improves to Grade 1 or less; for mild (Grade 1) rash consider topical corticosteroids. DOSE MODIFICATION — INFUSION REACTIONS: permanently discontinue for a life-threatening (Grade 4) infusion reaction; temporarily interrupt the infusion for Grade 1 to 3 infusion reactions and treat symptoms, then reduce the infusion rate by at least 50% when restarting after symptoms resolve; if the reaction recurs and is unmanageable, discontinue the infusion. PREPARATION: calculate the dose (mg/kg) and number of vials based on patient weight; discard any unused portion left in the vial; after preparation infuse immediately or store at 2 to 8 degrees C for no more than 24 hours from the time of preparation; do not freeze, do not shake. PRODUCT STRENGTH: 20 mg/5 mL (4 mg/mL) single-dose vial. PAEDIATRIC: 'The safety and effectiveness of POTELIGEO in pediatric patients have not been established' — no paediatric dose is stated, so paedDose is null; verify any under-18 use against a children's formulary. NO RENAL OR HEPATIC dose adjustment guidance appears in the fetched sections. The pregnancy, warnings and adverse-reactions sections were truncated at the source-fetch limit.