Active Ingredient: Loncastuximab tesirine
Loncastuximab tesirine as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 0.15 milligrams loncastuximab tesirine per kilogram of body weight, once every 21 days. This step is repeated 2 times. Afterwards, intravenous, 0.075 milligrams loncastuximab tesirine per kilogram of body weight, once every 21 days.
The recommended dose of loncastuximab tesirine is 0.15 mg/kg every 21 days for 2 cycles, followed by 0.075 mg/kg every 21 days for subsequent cycles until disease progression or unacceptable toxicity.
Unless contraindicated, dexamethasone 4 mg is to be administered orally or intravenously twice daily for 3 days, beginning the day before administering loncastuximab tesirine to mitigate pyrrolobenzodiazepine (PBD)-related toxicities. If dexamethasone administration does not begin the day before loncastuximab tesirine, oral or intravenous dexamethasone should begin at least 2 hours prior to administration of loncastuximab tesirine.
If a planned dose of loncastuximab tesirine is missed, it should be administered as soon as possible, and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
For dose modification for haematologic and nonhaematologic adverse reactions, see Table 1 below.
Table 1. Loncastuximab tesirine dose modification for haematologic and nonhaematologic adverse reactions:
| Adverse reactions | Severity | Dose modification |
|---|---|---|
| Haematologic adverse reactions | ||
| Neutropenia | Absolute neutrophil count less than 1 × 109/L | Withhold loncastuximab tesirine until neutrophil count returns to 1 × 109/L or higher |
| Thrombocytopenia | Platelet count less than 50,000/mcL | Withhold loncastuximab tesirine until platelet count returns to 50,000/mcL or higher |
| Nonhaematologic adverse reactions | ||
| Oedema or effusion | Grade 2 or higher | Withhold loncastuximab tesirine until the toxicity resolves to Grade 1 or less |
| Other adverse reactions | Grade 3 or higher | Withhold loncastuximab tesirine until the toxicity resolves to Grade 1 or less |
If dosing is delayed by more than 3 weeks due to toxicity related to loncastuximab tesirine, subsequent doses should be reduced by 50%. If toxicity requires dose reduction following the second dose of 0.15 mg/kg (Cycle 2), the patient should receive the dose of 0.075 mg/kg for Cycle 3.
If toxicity reoccurs after two dose reductions following an adverse reaction, permanent discontinuation of loncastuximab tesirine should be considered.
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