Active Ingredient: Belantamab mafodotin
Belantamab mafodotin is indicated in adults for the treatment of relapsed or refractory multiple myeloma in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 2.5 milligrams belantamab mafodotin per kilogram of body weight, one dose, over the duration of 4 weeks. Afterwards, intravenous, 1.9 milligrams belantamab mafodotin per kilogram of body weight, once every 4 weeks.
Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional before each of the first 4 doses of belantamab mafodotin treatment, and as clinically indicated thereafter.
Administration of belantamab mafodotin is to be continued according to the recommended schedule until disease progression or unacceptable toxicity. Belantamab mafodotin is administered in combination with other treatments (see Table 1). For other medicinal products that are administered with belantamab mafodotin, see section 5.1 and the respective current Summary of Product Characteristics.
Table 1. Recommended starting dose schedule for belantamab mafodotin in combination with other therapies:
| Combination regimen | Recommended starting dose schedule |
|---|---|
| With pomalidomide and dexamethasone (BPd) (Cycle length = 4 weeks) | Cycle 1: 2.5 mg/kg administered once Cycle 2 onwards: 1.9 mg/kg administered once every 4 weeks |
If a planned dose of belantamab mafodotin is missed due to reasons other than adverse reactions, it is recommended that belantamab mafodotin be resumed with the start of the next planned treatment cycle.
If a planned dose of belantamab mafodotin is missed due to adverse reactions, it is recommended that belantamab mafodotin be resumed with the start of the next planned treatment cycle after recovery of adverse reactions.
Dose modifications are required for nearly all patients to manage safety and tolerability. Dose reduction levels for belantamab mafodotin are provided in Table 2.
Table 2. Dose reduction schedule for belantamab mafodotin:
| Combination with pomalidomide and dexamethasone | |
|---|---|
| Recommended starting dose schedule | 2.5 mg/kg once on cycle 1 then 1.9 mg/kg every 4 weeks starting on cycle 2 |
| Reduced dose level 1 | 1.9 mg/kg every 8 weeks |
| Reduced dose level 2 | 1.4 mg/kg every 8 weeks |
Belantamab mafodotin is dosed based on baseline actual body weight and has been studied in patients with body weight 37 to 170 kg. For changes of body weight >10% during treatment, re-calculate dose based on the actual body weight at the time of dosing.
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