The recommended dose is 300 mg ofatumumab for the first infusion and 2,000 mg ofatumumab for all subsequent infusions. The infusion schedule is 8 consecutive weekly infusions, followed 4-5 weeks later by 4 consecutive monthly (i.e. every 4 weeks) infusions.
First and second infusions

The initial rate of the first and second infusion of Arzerra should be 12 ml/hour. During infusion, the rate should be doubled every 30 minutes to a maximum of 200 ml/hour (see section 6.6).

Subsequent infusions

If the second infusion has been completed without severe infusion related adverse drug reactions (ADRs), the remaining infusions can start at a rate of 25 ml/hour and should be doubled every 30 minutes up to a maximum of 400 ml/hour (see section 6.6).
Dose modification and reinitiation of therapy

Infusion related ADRs may lead to slower infusion rates.

• In case of a mild or moderate ADR, the infusion should be interrupted and restarted at half of the infusion rate at the time of interruption, when 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, according to physician discretion and patient tolerance (not to exceed doubling the rate every 30 minutes).
• In case 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, according to physician discretion and patient tolerance (not to exceed doubling the rate every 30 minutes).
Paediatric population

Arzerra is not recommended for use in children below 18 years due to insufficient data on safety and/or efficacy.

Elderly

No substantial differences were seen in safety and efficacy related to age. Based on available safety and efficacy data in the elderly, no dose adjustment is required (see section 5.2).

Renal impairment

No formal studies of Arzerra in patients with renal impairment have been performed. No dose adjustment is recommended for mild to moderate renal impairment (creatinine clearance >30 ml/min) (see section 5.2).

Hepatic impairment

No formal studies of Arzerra in patients with hepatic impairment have been performed. However, patients with hepatic impairment are unlikely to require dose modification (see section 5.2).

Method of administration

Arzerra is for intravenous infusion and must be diluted prior to administration(see section 6.6).
4.3 Contraindications

 Hypersensitivity to ofatumumab or to any of the excipients (see section 6.1).

4.4 Special warnings and precautions for use

 Infusion reactions

Ofatumumab has been associated with infusion reactions leading to temporary interruption of treatment or withdrawal of treatment. Pre-medications attenuate infusion reactions but these may still occur, predominantly during the first infusion. Infusion reactions may include anaphylactoid events, cardiac events, chills/rigors, cough, cytokine release syndrome, diarrhoea, dyspnoea, fatigue, flushing, hypertension, hypotension,