Active Ingredient: Talquetamab
Talquetamab is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least 3 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:
Regimen A: Subcutaneous, 0.01 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 to 4 days. Afterwards, subcutaneous, 0.06 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 to 4 days. Afterwards, subcutaneous, 0.4 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 1 week. Afterwards, subcutaneous, 0.4 milligrams talquetamab per kilogram of body weight, once weekly.
Regimen B: Subcutaneous, 0.01 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 to 4 days. Afterwards, subcutaneous, 0.06 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 to 4 days. Afterwards, subcutaneous, 0.4 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 to 4 days. Afterwards, subcutaneous, 0.8 milligrams talquetamab per kilogram of body weight, one dose, over the duration of 2 weeks. Afterwards, subcutaneous, 0.8 milligrams talquetamab per kilogram of body weight, once every 2 weeks.
Pre-treatment medicinal products should be administered prior to each dose of talquetamab during the step-up phase (see below).
Talquetamab should be administered subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 1. Patients who receive talquetamab according to the 0.4 mg/kg weekly dosing schedule and have attained an adequate clinical response that is confirmed in at least two consecutive disease assessments can be considered for switch to the 0.8 mg/kg biweekly dosing schedule.
Table 1. Recommended talquetamab dose:
| Dosing schedule | Phase | Day | Talquetamab dosea |
|---|---|---|---|
| Weekly dosing schedule | Step-up phase | Day 1 | 0.01 mg/kg |
| Day 3b | 0.06 mg/kg | ||
| Day 5b | 0.4 mg/kg | ||
| Treatment phase | Once a week thereafterc | 0.4 mg/kg | |
| Biweekly (every 2 weeks) dosing schedule | Step-up phase | Day 1 | 0.01 mg/kg |
| Day 3b | 0.06 mg/kg | ||
| Day 5b | 0.4 mg/kg | ||
| Day 7b | 0.8 mg/kg | ||
| Treatment phase | Once every 2 weeks thereafterc | 0.8 mg/kg |
a Based on actual body weight and administered subcutaneously.
b Dose may be administered between 2 to 4 days after the previous dose and may be given up to 7 days after the previous dose to allow for resolution of adverse reactions.
c Maintain a minimum of 6 days between weekly doses and a minimum of 12 days between biweekly (every 2 weeks) doses.
Patients should be instructed to remain within proximity of a healthcare facility and monitored for 48 hours after administration of all doses within the talquetamab step-up phase for signs and symptoms of CRS and ICANS.
Patients should be treated with talquetamab until disease progression or unacceptable toxicity.
The following pre-treatment medicinal products must be administered 1 to 3 hours before each dose of talquetamab during the step-up phase to reduce the risk of CRS.
Pre-treatment medicinal products should be administered prior to subsequent doses for patients who repeat doses within the talquetamab step-up phase due to dose delays (see Table 2) or for patients who experienced CRS.
Prior to starting treatment with talquetamab, prophylaxis should be considered for the prevention of infections, per local institutional guidelines.
If a dose of talquetamab is delayed, therapy should be restarted based on recommendations in Table 2, and weekly or biweekly dosing should be resumed accordingly (see Posology above). Pre-treatment medicinal products should be administered prior to restarting talquetamab, and patients should be monitored accordingly.
Table 2. Recommendations for restarting talquetamab after dose delay:
| Dosing schedule | Last dose administered | Time from last dose administered | Talquetamab recommendation* |
|---|---|---|---|
| Weekly dosing schedule | 0.01 mg/kg | More than 7 days | Restart at 0.01 mg/kg |
| 0.06 mg/kg | 8 to 28 days | Repeat 0.06 mg/kg | |
| More than 28 days | Restart at 0.01 mg/kg | ||
| 0.4 mg/kg | 8 to 35 days | Repeat 0.4 mg/kg | |
| 36 to 56 days | Restart at 0.06 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| Biweekly (every 2 weeks) dosing schedule | 0.01 mg/kg | More than 7 days | Restart at 0.01 mg/kg |
| 0.06 mg/kg | 8 to 28 days | Repeat 0.06 mg/kg | |
| More than 28 days | Restart at 0.01 mg/kg | ||
| 0.4 mg/kg | 8 to 35 days | Repeat 0.4 mg/kg | |
| 36 to 56 days | Restart at 0.06 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg | ||
| 0.8 mg/kg | 14 to 35 days | Repeat 0.8 mg/kg | |
| 36 to 56 days | Restart at 0.4 mg/kg | ||
| More than 56 days | Restart at 0.01 mg/kg |
* Administer pretreatment medicinal products prior to restarting talquetamab. After restarting talquetamab, resume weekly or biweekly (every 2 weeks) dosing accordingly.
The required volume of talquetamab should be injected into the subcutaneous tissue of the abdomen (preferred injection site). Alternatively, talquetamab may be injected into the subcutaneous tissue at other sites (e.g., thigh). If multiple injections are required, talquetamab injections should be at least 2 cm apart.
Talquetamab must not be injected into tattoos or scars or areas where the skin is red, bruised, tender, hard or not intact.
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