Indications : התוויות

4.1 Therapeutic indications
Fertility
Previously untreated chronic lymphocytic leukemia (CLL):                                                   There are no data on the effects of ofatumumab on human fertility. Effects on male and female Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of                 fertility have not been evaluated in animal studies.
patients with CLL who have not received prior therapy and who are not eligible for fludarabine- based therapy.                                                                                             4.7 Effects on ability to drive and use machines See section 5.1 for further information.                                                                   No studies on the effects of Arzerra on the ability to drive and use machines have been performed.
Refractory CLL:                                                                                            No detrimental effects on such activities are predicted from the pharmacology of ofatumumab.
Arzerra is indicated for the treatment of CLL in patients who are refractory to fludarabine and            The clinical status of the patient and the ADR profile of ofatumumab should be borne in mind alemtuzumab.                                                                                               when considering the patient’s ability to perform tasks that require judgement, motor or cognitive See section 5.1 for further information.                                                                   skills (see section 4.8).