Sodium content

This medicinal product contains 34.8 mg sodium per 300 mg dose and 232 mg sodium per 2,000 mg dose. This should be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction with other medicinal products and other forms of interaction

 Although no formal interaction studies have been performed with ofatumumab, there are no known clinically significant interactions with other medicinal products.

Live attenuated or inactivated vaccine efficacy may be impaired with ofatumumab. Therefore, the concomitant use of these agents with ofatumumab should be avoided. If the coadministration is judged unavoidable, the risks and benefits of vaccinating patients during therapy with ofatumumab should be considered (see section 4.4).

4.6 Pregnancy and lactation

 Pregnancy

There are no data from the use of ofatumumab in pregnant women. The effect on human pregnancy is unknown. Besides an expected pharmacological effect, i.e., depletion of B-cells, animal studies do not indicate direct or indirect harmful effects with respect to maternal toxicity, pregnancy or embryonal/foetal development (see section 5.3). Ofatumumab should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.

Women of childbearing potential should use effective contraception during and for 12 months after the last ofatumumab treatment.

Lactation

The safe use of ofatumumab in humans during lactation has not been established. The excretion of ofatumumab in milk has not been studied in animals. It is not known whether ofatumumab is secreted in human milk; however, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation. Breastfeeding should be discontinued for the duration of treatment with ofatumumab and for 12 months following treatment.

Fertility

There are no data on the effects of ofatumumab on human fertility. Effects on male and female fertility have not been eva luated in animal studies.

4.7 Effects on ability to drive and use machines

 No studies on the effects of Arzerra on the ability to drive and use machines have been performed.

No detrimental effects on such activities are predicted from the pharmacology of ofatumumab. The clinical status of the subject and the ADR profile of ofatumumab should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).

4.8 Undesirable effects

 The safety of ofatumumab in patients with relapsed or refractory CLL has been eva luated in two open-label studies. In study Hx-CD20-406, 154 patients were enrolled to receive an initial dose of 300 mg followed by 7 consecutive weekly infusions of 2,000 mg, followed five weeks later with 4 consecutive monthly infusions of 2,000 mg. The second study (Hx-CD20-402) was a dose-finding study and patients in three cohorts (3 patients, 3 patients, 27 patients) received a starting dose of 100 mg, 300 mg or 500 mg, followed a week later with 3 consecutive