Active Ingredient: Odronextamab
Odronextamab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 0.2 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 0.5 milligrams odronextamab, one dose, over the duration of 6 days. Afterwards, intravenous, 2 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 2 milligrams odronextamab, one dose, over the duration of 6 days. Afterwards, intravenous, 10 milligrams odronextamab, one dose, over the duration of 1 day. Afterwards, intravenous, 10 milligrams odronextamab, one dose, over the duration of 5 days. Afterwards, intravenous, 80 milligrams odronextamab, once every 7 days, over the duration of 21 days. This step is repeated 2 times. Afterwards, intravenous, 80 milligrams odronextamab, once every 7 days, 3 doses in total, over the duration of 28 days. Afterwards, intravenous, 160 milligrams odronextamab, once every 2 weeks, over the duration of 9 months. Afterwards, intravenous, 160 milligrams odronextamab, once every 4 weeks.
Odronextamab should be administered to well-hydrated patients.
Premedications must be administered for each dose in Cycle 1 and Cycle 2, Days 1 and 8 and post-medications for Cycle 1, Days 3, 10, and 17 and Cycle 2, Day 2 as described in Table 1 to reduce the risk of cytokine release syndrome (CRS) or infusion-related reactions (IRR). Premedications may be continued beyond Cycle 2, Day 8 until the dose is tolerated without experiencing CRS or IRR. In addition, prophylaxis is recommended to reduce the risk of infection, tumour lysis syndrome (TLS), and corticosteroid-induced gastrointestinal (GI) adverse reactions.
Table 1. Premedications and post-medications for patients with r/r FL:
| Treatment cycle and day | Medication | Dose | Administration relative to odronextamab infusion |
|---|---|---|---|
| Cycle 1: Days 1, 2, 8, 9, 15, and 16 | Corticosteroid | Dexamethasone 10 mg oral or equivalent Omit on days 2, 9, and 16 if infusions are given on consecutive days. | 12 to 24 hours prior to infusion |
| Corticosteroid | Dexamethasone 20 mg intravenous | 1 to 3 hours prior to infusion | |
| Antihistamine | Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine | 30 to 60 minutes prior to infusion | |
| Antipyretic | Paracetamol 650 mg to 1 000 mg oral | 30 to 60 minutes prior to infusion | |
| Cycle 1: Days 3, 10, and 17 | Corticosteroid | Dexamethasone 10 mg oral or equivalent | 24 hours after infusion |
| Cycle 2: Day 1 | Corticosteroid | Dexamethasone 10 mg oral or equivalent | 12 to 24 hours prior to infusion |
| Corticosteroid | Dexamethasone 20 mg intravenous | 1 to 3 hours prior to infusion | |
| Antihistamine | Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine | 30 to 60 minutes prior to infusion | |
| Antipyretic | Paracetamol 650 mg to 1 000 mg oral | 30 to 60 minutes prior to infusion | |
| Cycle 2: Day 2 | Corticosteroid | Dexamethasone 10 mg oral or equivalent | 24 hours after infusion |
| Cycle 2: Day 8 | Corticosteroid | Dexamethasone 10 mg* intravenous | 1 to 3 hours prior to infusion |
| Antihistamine | Diphenhydramine hydrochloride 25 mg oral or intravenous or equivalent antihistamine | 30 to 60 minutes prior to infusion | |
| Antipyretic | Paracetamol 650 mg to 1 000 mg oral | 30 to 60 minutes prior to infusion |
* If CRS or IRR occurs with the Cycle 2 Day 1 dose, administer dexamethasone 20 mg intravenously for the next dose until the dose is tolerated without experiencing CRS or IRR.
The recommended dose for odronextamab is presented in Table 2. For Cycles 1 to 4, a treatment cycle is 21 days. Each dose should only be administered if the previous dose is tolerated.
Odronextamab should be administered until disease progression or unacceptable toxicity.
Table 2. Recommended dose:
| r/r FL | |||
|---|---|---|---|
| Day of treatment | Dose of odronextamab | Duration of infusion | |
| Cycle 1a (Step-up dosing) | Day 1 | 0.2 mg | Administer odronextamab as a 4-hour infusion. |
| Day 2 | 0.5 mg | ||
| Day 8 | 2 mg | ||
| Day 9 | 2 mg | ||
| Day 15 | 10 mg | ||
| Day 16 | 10 mg | ||
| Cycles 2 to 4a | Day 1 | 80 mg | Administer odronextamab as a 4-hour infusion on Cycle 2, Day 1. If tolerated, for all subsequent doses starting on Cycle 2, Day 8, infusion time can be reduced to 1 hour. |
| Day 8 | 80 mg | ||
| Day 15 | 80 mg | ||
| Maintenance (Every 2 weeks) | Begin 1 week after the end of Cycle 4 | 160 mg | Administer odronextamab as a 1-hour infusion every two weeks until disease progression or unacceptable toxicity. |
| Maintenance (Every 4 weeks) | If a patient is in complete response (CR) for 9 months, administer the odronextamab maintenance dose every 4 weeks. | 160 mg | Administer odronextamab as a 1-hour infusion every 4 weeks until disease progression or unacceptable toxicity. |
r/r FL=relapsed or refractory follicular lymphoma
B-cell lymphoma
a For Cycles 1 to 4, a treatment cycle is 21 days.
Table 3 provides recommendations for restarting therapy after a dose delay.
Table 3. Recommendations for restarting therapy with odronextamab after a dose delay:
| Cycle | Day | Last dose administered | Time since the last dose administered | Action for next dose |
|---|---|---|---|---|
| 1 | 1 | 0.2 mg | Greater than 3 days | Restart from 0.2 mg (Cycle 1, Day 1) |
| 2 | 0.5 mg | Less than 2 weeks | Administer next scheduled dosea | |
| 2 weeks or longer | Restart from 0.2 mg (Cycle 1, Day 1) | |||
| 8 and 9 | 2 mg | Less than 3 weeks | Administer next scheduled dosea | |
| 3 to 4 weeks | Administer 2 mg (Cycle 1, Day 9), then resume the planned treatment schedule. | |||
| Greater than 4 weeks | Restart from 0.2 mg (Cycle 1, Day 1) | |||
| 15 and 16 | 10 mg | Less than 3 weeks | Administer next scheduled dosea | |
| 3 to 5 weeks | Administer 10 mg (Cycle 1, Day 16), and then resume the planned treatment schedule. | |||
| Greater than 5 weeks | Restart from 0.2 mg (Cycle 1, Day 1) | |||
| 2 to 4 | 1, 8, 15 | • r/r FL: 80 mg | Less than 7 weeks | Administer next scheduled dosea |
| 7 to 10 weeks | Administer 10 mg (Cycle 1, Day 16), then resume the planned treatment schedule. | |||
| Greater than 10 weeks | Restart from 0.2 mg (Cycle 1, Day 1) | |||
| Maintenance | Every 2 weeks OR Every 4 weeks after CR maintained for 9 months | • r/r FL: 160 mg | Less than 7 weeks | Administer next scheduled dosea |
| 7 to 10 weeks | Administer 10 mg (Cycle 1, Day 16), then resume the planned treatment schedule. | |||
| Greater than 10 weeks | Restart from 0.2 mg (Cycle 1, Day 1) |
NOTE: Administer premedications and post-medications as per Table 1.
r/r FL=relapsed or refractory follicular lymphoma
B-cell lymphoma
a As per Table 2, resume the treatment schedule without skipping doses.
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