Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT
 Arzerra 1,000 mg concentrate for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
 One ml of concentrate contains 20 mg of ofatumumab.
Each vial contains 1,000 mg of ofatumumab in 50 ml.
Ofatumumab is a human monoclonal antibody produced in a recombinant murine cell line (NS0).
Excipients:
This medicinal product contains 34.8 mg sodium per 300 mg dose and 232 mg sodium per 2,000 mg dose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
 Concentrate for solution for infusion (sterile concentrate).
Clear to slightly opalescent, colourless liquid. Visible particles may be present.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
 Arzerra is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.
4.2 Posology and method of administration

 Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Pre-medication
Patients should be pre-medicated 30 minutes to 2 hours prior to Arzerra infusion according to the following dosing schedule:
Infusion number (dose)
 Intravenous corticosteroid dose
 Analgesic dose
 Antihistamine dose
1 (300 mg)
 Equivalent to 100 mg prednisolone
 Equivalent to 1,000 mg paracetamol
 Equivalent to 10 mg cetirizine
2 (2,000 mg)
 Equivalent to 100 mg prednisolone
 Equivalent to 1,000 mg paracetamol
 Equivalent to 10 mg cetirizine
3-8 (2,000 mg)
 Equivalent to 0-100 mg prednisolone a)
 Equivalent to 1,000 mg paracetamol
 Equivalent to 10 mg cetirizine
9 (2,000 mg)
 Equivalent to 100 mg prednisolone
 Equivalent to 1,000 mg paracetamol
 Equivalent to 10 mg cetirizine
10-12 (2,000 mg)
 Equivalent to 50-100 mg prednisolone b)
 Equivalent to 1,000 mg paracetamol
 Equivalent to 10 mg cetirizine
a) If the second infusion is completed without a severe adverse drug reaction, the dose may be reduced at the discretion of the physician.

b) If the