Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated Chronic Lymphocytic Leukemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

EMA

Class:

CD20 MAb

Newly Diagnosed

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002799/WC500171594.pdf

1. Approved Labelling

Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated Chronic Lymphocytic Leukemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine-based therapy.

2. Treatment Regimen

For patients with CLL the recommended dose of Gazyvaro in combination with chlorambucil is shown in Table 1.

Table 1: Dose of Gazyvaro to be administered during 6 treatment cycles each of 28 days duration for patients with CLL

Cycle Day of treatment Dose of Gazyvaro
Cycle 1 Day 1  100 mg
Day 2 (or Day 1 continued) 900 mg
Day 8 1,000 mg
Day 15 1,000 mg
Cycles 2-6  Day 1 1,000 mg
Cycle 1

The recommended dose of Gazyvaro 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.

Cycle 2-6

The recommended dose of Gazyvaro in combination with chlorambucil is 1,000 mg administered on Day 1 of each cycle.Duration of treatment Six treatment cycles, each of

Duration of treatment Six treatment cycles, each of 28-day duration. Delayed or missed doses if a planned dose of Gazyvaro is missed, it should be administered as soon as possible; do not wait until the next planned dose. The planned treatment interval for Gazyvaro should be maintained between doses.

3. AE/Warnings

Please see section 4.4 of the SmPC

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