Active Ingredient: Glofitamab
Glofitamab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 2.5 milligrams glofitamab, one dose, over the duration of 7 days. Afterwards, intravenous, 10 milligrams glofitamab, one dose, over the duration of 7 days. Afterwards, intravenous, 30 milligrams glofitamab, one dose, over the duration of 21 days. Afterwards, intravenous, 30 milligrams glofitamab, one dose, over the duration of 21 days. This step is repeated 10 times.
All patients in study NP30179 received a single 1 000 mg dose of obinutuzumab as pre-treatment on Cycle 1 Day 1 (7 days prior to initiation of glofitamab treatment) to lower the circulating and lymphoid B cells (see Table 2, Delayed or Missed Doses).
Obinutuzumab was administered as an intravenous infusion at 50 mg/h. The rate of infusion was escalated in 50 mg/h increments every 30 minutes to a maximum of 400 mg/h.
Refer to the obinutuzumab prescribing information for complete information on premedication, preparation, administration and management of adverse reactions of obinutuzumab.
Glofitamab should be administered to well-hydrated patients. Recommended premedication for CRS is outlined in Table 1.
Table 1. Premedication before glofitamab infusion:
| Treatment cycle (Day) | Patients requiring premedication | Premedication | Administration |
|---|---|---|---|
| Cycle 1 (Day 8, Day 15); Cycle 2 (Day 1); Cycle 3 (Day 1) | All patients | Intravenous glucocorticoid1 | Completed at least 1 hour prior to glofitamab infusion |
| Oral analgesic / anti-pyretic2 | At least 30 minutes before glofitamab infusion | ||
| Anti-histamine3 | |||
| All subsequent infusions | All patients | Oral analgesic / anti-pyretic2 | At least 30 minutes before glofitamab infusion |
| Anti-histamine3 | |||
| Patients who experienced CRS with the previous dose | Intravenous glucocorticoid1,4 | Completed at least 1 hour prior to glofitamab infusion |
1 20 mg dexamethasone or 100 mg prednisone/prednisolone or 80 mg methylprednisolone.
2 For example, 1 000 mg paracetamol.
3 For example, 50 mg diphenhydramine.
4 To be administered in addition to the premedication required for all patients.
Glofitamab dosing begins with a step-up dosing schedule (which is designed to decrease the risk of CRS), leading to the recommended dose of 30 mg.
Glofitamab must be administered as an intravenous infusion according to the dose step-up schedule leading to the recommended dose of 30 mg (as shown in Table 2), after completion of pre-treatment with obinutuzumab on Cycle 1 Day 1. Each cycle is 21 days.
Table 2. glofitamab monotherapy dose step-up schedule for patients with relapsed or refractory DLBCL:
| Treatment cycle, Day | Dose of glofitamab | Duration of infusion | |
|---|---|---|---|
| Cycle 1 (Pre-treatment and step-up dose) | Day 1 | Pre-treatment with obinutuzumab1 | |
| Day 8 | 2.5 mg | 4 hours2 | |
| Day 15 | 10 mg | ||
| Cycle 2 | Day 1 | 30 mg | |
| Cycle 3 to 12 | Day 1 | 30 mg | 2 hours3 |
1 Refer to “Pre-treatment with obinutuzumab” described above.
2 For patients who experience CRS with their previous dose of glofitamab, the duration of infusion may be extended up to 8 hours.
3 At the discretion of the treating physician, if the previous infusion was well tolerated. If the patient experienced CRS with a previous dose, the duration of infusion should be maintained at 4 hours.
All patients must be counselled on the risk, signs and symptoms of CRS and advised to contact the healthcare provider immediately should they experience signs and symptoms of CRS.
Treatment with glofitamab is recommended for a maximum of 12 cycles or until disease progression or unmanageable toxicity. Each cycle is 21 days.
During step-up dosing (weekly dosing):
After Cycle 2 (30 mg dose):
No dose reductions of glofitamab are recommended.
It must be administered as an intravenous infusion through a dedicated infusion line.
Glofitamab must not be administered as an intravenous push or bolus.
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