Chronic lymphocytic leukaemia (CLL)

Previously untreated CLL

For previously untreated CLL, the recommended dosage and schedule is:

• Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8.
• Subsequent cycles (until best response or a maximum of 12 cycles): 1000 mg on day 1 every 28 days.

Each cycle lasts 28 days and is counted from day 1 of the cycle.

Best response is a clinical response that did not improve with 3 additional cycles of treatment.

Relapsed CLL

For relapsed CLL, the recommended dosage and schedule is:

• Cycle 1: 300 mg on day 1 followed 1 week later by 1000 mg on day 8.
• Subsequent cycles (up to a maximum of 6 cycles in total): 1000 mg on day 1 every 28 days.

Each cycle lasts 28 days and is counted from day 1 of the cycle.

Previously untreated CLL and relapsed CLL

First infusion

The initial rate of the first infusion of ofatumumab should be 12 ml/h. During infusion, the rate should be increased every 30 minutes to a maximum of 400 ml/h.

Subsequent infusions

If the preceding infusion(s) has (have) been completed without severe infusion related ADRs, the subsequent infusions can start at a rate of 25 ml/h and should be increased every 30 minutes up to a maximum of 400 ml/h.

Dose modification and reinitiation of therapy after infusion-related ADRs

In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption once the patient’s condition is stable. If the infusion rate had not been increased from the starting rate of 12 ml/hour prior to interrupting due to an ADR, the infusion should be restarted at 12 ml/hour, the standard starting infusion rate. The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes).

In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour when the patient’s condition is stable. The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed increasing the rate every 30 minutes).

Ofatumumab should be permanently discontinued in patients who develop an anaphylactic reaction to the medicinal product.

Refractory CLL

The recommended dose and schedule is 12 doses administered as follows:

• 300 mg on day 1 followed 1 week later by
• 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
• 2000 mg every 28 days for 4 doses (infusions 9 to 12)

First and second infusions

The initial rate of the first and second infusion of ofatumumab should be 12 ml/hour. During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour.

Subsequent infusions

If the preceding infusion(s) has (have) been completed without severe infusion-related ADRs, the subsequent infusions can start at a rate of 25 ml/hour and should be increased every 30 minutes up to a maximum of 400 ml/hour.

Dose modification and reinitiation of therapy after infusion-related ADRs

In the event of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption, once the patient’s condition is stable. If the infusion rate had not been increased from the starting rate of 12 ml/hour prior to interrupting due to an ADR, the infusion should be restarted at 12 ml/hour, the standard starting infusion rate. The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed doubling the rate every 30 minutes).

In the event of a severe ADR, the infusion should be interrupted and restarted at 12 ml/hour, once the patient’s condition is stable. The infusion rate can continue to be increased according to standard procedures, to physician discretion and to patient tolerance (not to exceed increasing the rate every 30 minutes).

The initial rate of the first and second infusion of ofatumumab should be 12 ml/hour. During infusion, the rate should be increased every 30 minutes to a maximum of 200 ml/hour.