Active Ingredient: Elranatamab
Elranatamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 12 milligrams elranatamab, one dose, over the duration of 3 days. Afterwards, subcutaneous, 32 milligrams elranatamab, one dose, over the duration of 3 days. Afterwards, subcutaneous, 76 milligrams elranatamab, once weekly, over the duration of 23 weeks. Afterwards, subcutaneous, 76 milligrams elranatamab, once every 2 weeks.
The recommended doses are step-up doses of 12 mg on day 1 and 32 mg on day 4, followed by a full treatment dose of 76 mg weekly from week 2 to week 24 (see Table 1).
For patients who have received at least 24 weeks of treatment and have achieved a response, the dosing interval should transition to an every two-week schedule.
Elranatamab should be administered according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of CRS and ICANS. Due to the risk of CRS and ICANS, patients should be monitored for signs and symptoms for 48 hours after administration of each of the 2 step-up doses and instructed to remain within proximity of a healthcare facility.
Table 1. Elranatamab dosing schedule:
| Dosing schedule | Week/day | Dose | |
|---|---|---|---|
| Step-up dosinga,b | Week 1: day 1 | Step-up dose 1 | 12 mg |
| Week 1: day 4 | Step-up dose 2 | 32 mg | |
| Weekly dosinga,c,d | Week 2-24: day 1 | Full treatment dose | 76 mg once weekly |
| Every 2 weeks dosingd,e | Week 25 onward: day 1 | Full treatment dose | 76 mg once every two weeks |
a Pre-treatment medicinal products should be administered prior to the first three doses of elranatamab.
b A minimum of 2 days should be maintained between step-up dose 1 (12 mg) and step-up dose 2 (32 mg).
c A minimum of 3 days should be maintained between step-up dose 2 (32 mg) and the first full treatment (76 mg) dose.
d A minimum of 6 days should be maintained between doses.
e For patients who have achieved a response.
Note: See Table 2 for recommendations on restarting elranatamab after dose delays.
The following pre-treatment medicinal products should be administered approximately 1 hour prior to the first three doses of elranatamab, which includes step-up dose 1, step-up dose 2, and the first full treatment dose as described in Table 1 to reduce the risk of CRS:
Prophylactic antimicrobials and anti-virals should be considered according to local institutional guidelines.
If a dose is delayed, therapy should be restarted based on the recommendations listed in Table 5, and therapy should be resumed according to the dosing schedule (see Table 1). Pre-treatment medicinal products should be administered as indicated in Table 2.
Table 2. Recommendations for restarting therapy with Elranatamab after dose delay:
| Last administered dose | Duration of delay from the last administered dose | Action |
|---|---|---|
| Step-up dose 1 (12 mg) | 2 weeks or less (≤14 days) | Restart at step-up dose 2 (32 mg).a If tolerated, increase to 76 mg 4 days later. |
| Greater than 2 weeks (>14 days) | Restart step-up dosing schedule at step-up dose 1 (12 mg).a | |
| Step-up dose 2 (32 mg) | 2 weeks or less (≤14 days) | Restart at 76 mg.a |
| Greater than 2 weeks to less than or equal to 4 weeks (15 days and ≤28 days) | Restart at step-up dose 2 (32 mg).a If tolerated, increase to 76 mg 1 week later. | |
| Greater than 4 weeks (>28 days) | Restart step-up dosing schedule at step-up dose 1 (12 mg).a | |
| Any full treatment dose (76 mg) | 6 weeks or less (≤42 days) | Restart at 76 mg. |
| Greater than 6 weeks to less or equal to 12 weeks (43 days to ≤84 days) | Restart at step-up dose 2 (32 mg).a If tolerated, increase to 76 mg 1 week later. | |
| Greater than 12 weeks (>84 days) | Restart step-up dosing schedule at step-up dose 1 (12 mg).a |
a Administer pre-treatment medicinal products prior to the elranatamab dose.
Treatment should be continued until disease progression or unacceptable toxicity.
If a dose is missed, the dose should be administered as soon as possible, and the dosing schedule should be adjusted to maintain the dosing interval as needed (see Table 1).
The required dose should be injected into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, it may be injected into the subcutaneous tissue of the thigh.
Elranatamab should not be injected into areas where the skin is red, bruised, tender, hard, or areas where there are scars.
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