Active Ingredient: Obinutuzumab
Obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 7 days. Afterwards, intravenous, 1,000 milligrams obinutuzumab, one dose, over the duration of 14 days. Afterwards, intravenous, 1,000 milligrams obinutuzumab, once every 28 days. This step is repeated 5 times. Afterwards, intravenous, 1,000 milligrams obinutuzumab, once every 2 months, over the duration of 2 years.
For patients with FL, the recommended dose of obinutuzumab in combination with chemotherapy is shown in table below.
<υ>Induction (in combination with bendamustine):Obinutuzumab should be administered in six 28-day cycles in combination with bendamustine.
<υ>Maintenance:Patients who achieved a complete or partial response to induction treatment (i.e. the initial 6 treatment cycles) with obinutuzumab in combination with bendamustine or have stable disease should continue to receive obinutuzumab 1,000 mg as single agent maintenance therapy once every 2 months for 2 years or until disease progression (whichever occurs first).
Follicular lymphoma: Dose of obinutuzumab to be administered during induction treatment, followed by maintenance treatment:
| Cycle | Day of treatment | Dose of Gazyvaro |
|---|---|---|
| Cycle 1 | Day 1 | 1,000 mg |
| Day 8 | 1,000 mg | |
| Day 15 | 1,000 mg | |
| Cycles 2–6 | Day 1 | 1,000 mg |
| Maintenance | Every 2 months for 2 years or until disease progression (whichever occurs first) | 1,000 mg |
Induction treatment of approximately six months (six treatment cycles of obinutuzumab, each of 28 day duration when combined with bendamustine, or eight treatment cycles of obinutuzumab, each of 21 day duration when combined with CHOP or CVP) followed by maintenance once every 2 months for 2 years or until disease progression (whichever occurs first).
If a planned dose of obinutuzumab is missed, it should be administered as soon as possible; do not omit it or wait until the next planned dose. If toxicity occurs before Cycle 1 Day 8 or Cycle 1 Day 15, requiring delay of treatment, these doses should be given after resolution of toxicity. In such instances, all subsequent visits and the start of Cycle 2 will be shifted to accommodate for the delay in Cycle 1.
During maintenance, maintain the original dosing schedule for subsequent doses.
No dose reductions of obinutuzumab are recommended.
Obinutuzumab is for intravenous use. It should be given as an intravenous infusion through a dedicated line after dilution. Obinutuzumab infusions should not be administered as an intravenous push or bolus.
Instructions on the rate of infusion are shown in the following table.
Follicular lymphoma: Standard infusion rate in the absence of IRRs/hypersensitivity and recommendations in case an IRR occurred with previous infusion:
| Cycle | Day of treatment | Rate of infusion |
|---|---|---|
| The infusion rate may be escalated provided that the patient can tolerate it. For management of IRRs that occur during the infusion, refer to "Management of IRRs". | ||
| Cycle 1 | Day 1 (1,000 mg) | Administer at 50 mg/hr. The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. |
| Day 8 (1,000 mg) | If no IRR or if an IRR Grade 1 occurred during the previous infusion when the final infusion rate was 100 mg/hr or faster, infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. If the patient experienced an IRR of Grade 2 or higher during the previous infusion administer at 50 mg/hr. The rate of infusion can be escalated in 50 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. | |
| Day 15 (1,000 mg) | ||
| Cycles 2-6 or 2–8 | Day 1 (1,000 mg) | |
| Maintenance | Every 2 months for 2 years or until disease progression (whichever occurs first) | |
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of obinutuzumab as outlined below.
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of obinutuzumab as outlined below.
Follicular lymphoma (FL):
IRRs occurring during SDI:
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