Active Ingredient: Belantamab mafodotin
Belantamab mafodotin is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 2.5 milligrams belantamab mafodotin per kilogram of body weight, once every 3 weeks.
Patients should have an ophthalmic examination (including visual acuity and slit lamp examination) performed by an eye care professional at baseline, before the subsequent 3 treatment cycles, and as clinically indicated whilst on treatment.
Physicians should advise patients to administer preservative-free artificial tears at least 4 times a day beginning on the first day of infusion and continuing until completion of treatment as this may reduce corneal symptoms.
For patients with dry eye symptoms, additional therapies may be considered as recommended by their eye care professional.
The recommended dose is 2.5 mg/kg of belantamab mafodotin administered as an intravenous infusion once every 3 weeks.
It is recommended that treatment should be continued until disease progression or unacceptable toxicity.
Recommended dose modifications for corneal adverse reactions are provided in Table 1. Table 2 provides dose modifications recommended for other adverse reactions.
Corneal adverse reactions may include findings upon eye examination and/or changes in visual acuity. The treating physician should review the patient’s ophthalmic examination report before dosing and should determine the dose of belantamab mafodotin based on the highest category from the report in the most severely affected eye as both eyes may not be affected to the same degree (Table 1).
During the ophthalmic examination, the eye care professional should assess the following:
Table 1. Dose modifications for corneal adverse reactions:
| Categorya | Eye examination findings | Recommended dose modifications |
|---|---|---|
| Mild | Corneal examination finding(s) Mild superficial keratopathyb Change in BCVA Decline from baseline of 1 line on Snellen Visual Acuity | Continue treatment at current dose. |
| Moderate | Corneal examination finding(s) Moderate superficial keratopathyc Change in BCVA Decline from baseline of 2 or 3 lines (and Snellen Visual Acuity not worse than 20/200) | Withhold treatment until improvement in examination findings and BCVA to mild severity or better. Consider resuming treatment at a reduced dose of 1.9 mg/kg. |
| Severe | Corneal examination finding(s) Severe superficial keratopathyd Corneal epithelial defecte Change in BCVA Decline from baseline of more than 3 lines on Snellen Visual Acuity | Withhold until improvement in examination findings and BCVA to mild severity or better. For worsening symptoms that are unresponsive to appropriate management, consider discontinuation. |
a The severity category is defined by the most severely affected eye as both eyes may not be affected to the same degree.
b Mild superficial keratopathy (documented worsening from baseline), with or without symptoms.
c Moderate superficial keratopathy – with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity.
d Severe superficial keratopathy with or without diffuse microcyst-like deposits involving the central cornea, sub-epithelial haze (central), or a new central stromal opacity.
e A corneal defect may lead to corneal ulcers. These should be managed promptly and as clinically indicated by an eye care professional.
Table 2. Dose modifications for other adverse reactions:
| Adverse reaction | Severity | Recommended dose modifications |
|---|---|---|
| Thrombocytopenia | Grade 2-3: Platelet count 25,000 to less than 75,000/microlitres | Consider withholding belantamab mafodotin and/or reducing the dose of belantamab mafodotin to 1.9 mg/kg. |
| Grade 4: Platelet count less than 25,000/microlitres | Withhold belantamab mafodotin until platelet count improves to Grade 3 or better. Consider resuming at a reduced dose of 1.9 mg/kg. | |
| Infusion-related reactions | Grade 2 (moderate) | Interrupt infusion and provide supportive treatment. Once symptoms resolve, resume at lower infusion rate by at least 50%. |
| Grade 3 or 4 (severe) | Interrupt infusion and provide supportive treatment. Once symptoms resolve, resume at lower infusion rate reduced by at least 50%. If anaphylactic or life-threatening infusion reaction, permanently discontinue the infusion and institute appropriate emergency care. |
Adverse reactions were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
BLENREP has not been studied in patients with body weight <40 kg or >130 kg.
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