Active Ingredient: Teclistamab
Teclistamab 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, in total 0.06 milligrams teclistamab per kilogram of body weight, one dose, over the duration of 2 days. Afterwards, subcutaneous, in total 0.3 milligrams teclistamab per kilogram of body weight, one dose, over the duration of 2 to 7 days. Afterwards, subcutaneous, in total 1.5 milligrams teclistamab per kilogram of body weight, one dose, over the duration of 1 week. Afterwards, subcutaneous, 1.5 milligrams teclistamab per kilogram of body weight, once weekly.
Pre-treatment medicinal products should be administered prior to each dose of teclistamab in the step-up dosing schedule (see below).
Teclistamab step-up dosing schedule should not be administered in patients with active infection.
The recommended dosing schedule for teclistamab is provided in Table 1. The recommended doses of teclistamab are 1.5 mg/kg by subcutaneous injection (SC) weekly, preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg.
Treatment with teclistamab should be initiated according to the step-up dosing schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome. Due to the risk of cytokine release syndrome, patients should be instructed to remain within proximity of a healthcare facility, and monitored for signs and symptoms daily for 48 hours after administration of all doses within the teclistamab step-up dosing schedule.
Failure to follow the recommended doses or dosing schedule for initiation of therapy, or re-initiation of therapy after dose delays, may result in increased frequency and severity of adverse reactions related to mechanism of action, particularly cytokine release syndrome.
Table 1. Teclistamab dosing schedule:
| Dosing schedule | Day | Dosea | |
|---|---|---|---|
| Step-up dosing schedulee | Day 1 | Step-up dose 1 | 0.06 mg/kg single dose |
| Day 3b | Step-up dose 2 | 0.3 mg/kg single dose | |
| Day 5c | First maintenance dose | 1.5 mg/kg single dose | |
| Weekly dosing schedulee | One week after first maintenance dose and weekly thereafterd | Subsequent maintenance doses | 1.5 mg/kg once weekly |
a Dose is based on actual body weight and should be administered subcutaneously.
b Step-up dose 2 may be given between 2 to 7 days after Step-up dose 1.
c First maintenance dose may be given between 2 to 7 days after Step-up dose 2. This is the first full treatment dose (1.5 mg/kg).
d Maintain a minimum of five days between weekly maintenance doses.
e See Table 2 for recommendations on restarting teclistamab after dose delays.
Patients should be treated with teclistamab until disease progression or unacceptable toxicity.
The following pre-treatment medicinal products must be administered 1 to 3 hours before each dose of the teclistamab step-up dosing schedule (see Table 1) to reduce the risk of cytokine release syndrome.
Administration of pre-treatment medicinal products may also be required prior to administration of subsequent doses of teclistamab for the following patients:
Prior to starting treatment with teclistamab, antiviral prophylaxis should be considered for the prevention of herpes zoster virus reactivation, per local institutional guidelines.
If a dose of teclistamab is delayed, therapy should be restarted based on the recommendations listed in Table 2 and teclistamab resumed according to the dosing schedule (see Table 1). Pre-treatment medicinal products should be administered as indicated in Table 2. Patients should be monitored accordingly.
Table 2. Recommendations for restarting therapy with teclistamab after dose delay:
| Last dose administered | Duration of delay from the last dose administered | Action |
|---|---|---|
| Step-up dose 1 | More than 7 days | Restart teclistamab step-up dosing schedule at Step-up dose 1 (0.06 mg/kg)a. |
| Step-up dose 2 | 8 days to 28 days | Repeat Step-up dose 2 (0.3 mg/kg)a and continue teclistamab step-up dosing schedule. |
| More than 28 days | Restart teclistamab step-up dosing schedule at Step-up dose 1 (0.06 mg/kg)a. | |
| Any maintenance doses | 8 days to 28 days | Continue teclistamab dosing schedule at maintenance dose (1.5 mg/kg)a. |
| more than 28 days | Restart teclistamab step-up dosing schedule at Step-up dose 1 (0.06 mg/kg)a. |
a Pre-treatment medicinal products should be administered prior to teclistamab dose and patients monitored accordingly.
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