Gemtuzumab Ozogamicin

SOURCE: no UK SPC was fetched in this bundle (providers.emc is null) — this draft is distilled from the US Mylotarg prescribing information and must be verified against the UK SPC. OTHER REGIMENS: (1) NEWLY-DIAGNOSED CD33-POSITIVE AML, SINGLE AGENT (adults) — induction 6 mg/m2 (not limited to one 4.5 mg vial) on Day 1 and 3 mg/m2 (not limited to one 4.5 mg vial) on Day 8; for patients without evidence of disease progression after induction, up to 8 continuation courses of 2 mg/m2 (not limited to one 4.5 mg vial) on Day 1 every 4 weeks. (2) RELAPSED OR REFRACTORY CD33-POSITIVE AML, SINGLE AGENT (adults and paediatric patients 2 years and older) — 3 mg/m2 (up to one 4.5 mg vial) on Days 1, 4 and 7, as a single course. PREMEDICATION (adults): paracetamol (acetaminophen) 650 mg orally and diphenhydramine 50 mg orally or intravenously 1 hour before dosing, plus methylprednisolone 1 mg/kg or an equivalent dose of an alternative corticosteroid within 30 minutes before the infusion; repeat the same corticosteroid dose for any sign of an infusion reaction such as fever, chills, hypotension or dyspnoea during the infusion or within 4 hours afterwards. SPECIAL CONSIDERATIONS: use appropriate measures to prevent tumour lysis syndrome; for hyperleukocytosis (leukocyte count 30 Gi/L or greater) cytoreduction is recommended before administration. TOXICITY: monitor blood counts frequently through resolution of cytopenias, and blood counts and chemistries at least three times per week through recovery from treatment-related toxicities; some adverse reactions require dose interruption or permanent discontinuation — for patients on combination therapy with persistent thrombocytopenia, if the adult platelet count does not recover to 100 Gi/L or greater within 14 days following the planned start date of the consolidation cycle (14 days after haematologic recovery from the previous cycle), discontinue. The fetched dose-modification table is truncated — consult the full label.

0.1 mg/kg applies ONLY to patients with a body surface area of less than 0.6 m2. Paediatric patients 1 month and older with a BSA of 0.6 m2 or greater receive 3 mg/m2 instead (not a per-kg dose). Safety and effectiveness have not been established in children under 1 month of age, or for single-agent use in newly-diagnosed paediatric AML. Paediatric premedication per the US label: paracetamol (acetaminophen) 15 mg/kg (maximum 650 mg) and diphenhydramine 1 mg/kg (maximum 50 mg) 1 hour before dosing, plus methylprednisolone 1 mg/kg orally or intravenously within 30 minutes before the infusion, with additional doses of paracetamol and diphenhydramine every 4 hours after the initial pretreatment dose if needed. US labelling only — verify against the UK SPC, a children's formulary and the local paediatric oncology protocol before use.