Active Ingredient: Obinutuzumab
Obinutuzumab in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 100 milligrams obinutuzumab, one dose, over the duration of 1 day. Afterwards, intravenous, 900 milligrams obinutuzumab, one dose, over the duration of 6 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.
For patients with CLL the recommended dose of obinutuzumab in combination with chlorambucil is shown in the table below.
The recommended dose of obinutuzumab in combination with chlorambucil is 1 000 mg administered over Day 1 and Day 2, (or Day 1 continued), and on Day 8 and Day 15 of the first 28 day treatment cycle.
Two infusion bags should be prepared for the infusion on Days 1 and 2 (100 mg for Day 1 and 900 mg for Day 2). If the first bag is completed without modifications of the infusion rate or interruptions, the second bag may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions and medical supervision are available throughout the infusion. If there are any modifications of the infusion rate or interruptions during the first 100 mg the second bag must be administered the following day.
The recommended dose of obinutuzumab in combination with chlorambucil is 1 000 mg administered on Day 1 of each cycle.
Dose of obinutuzumab to be administered during 6 treatment cycles each of 28 days duration for patients with CLL:
| Cycle | Day of treatment | Dose of obinutuzumab |
|---|---|---|
| Cycle 1 | Day 1 | 100 mg |
| Day 2 (or Day 1 continued) | 900 mg | |
| Day 8 | 1 000 mg | |
| Day 15 | 1 000 mg | |
| Cycle 2–6 | Day 1 | 1 000 mg |
Six treatment cycles, each of 28 day duration.
If a planned dose of obinutuzumab is missed, it should be administered as soon as possible; do not wait until the next planned dose. The planned treatment interval for obinutuzumab should be maintained between 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.
Chronic lymphocytic leukaemia: 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 |
|---|---|---|
| TThe 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 (100 mg) | Administer at 25 mg/hr over 4 hours. Do not increase the infusion rate |
| Day 2 (or Day 1 continued) (900 mg) | If no IRR occurred during the previous infusion, administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. If the patient experienced an IRR during the previous infusion, start with administration at 25 mg/hr. The rate of infusion can be escalated in increments up to 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. | |
| Day 8 (1 000 mg) | If no IRR 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 during the previous infusion administer at 50 mg/hr. The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr. | |
| Day 15 (1 000 mg) | ||
| Cycles 2-6 | Day 1 (1 000 mg) | |
Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of obinutuzumab as outlined below.
Chronic lymphocytic leukaemia (CLL):
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