Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Woman of childbearing potential/Contraception in the males and females Empliciti should not be used in women of childbearing potential, unless the clinical condition of the woman requires treatment with elotuzumab. Women of childbearing potential should use effective contraception during and for 120 days following treatment.
Male patients must use effective contraception measures during and for 180 days following treatment if their partner is pregnant or of childbearing potential and not using effective contraception.

Pregnancy
There is no human experience with elotuzumab during pregnancy. Elotuzumab will be given in combination with lenalidomide, which is contraindicated during pregnancy. No animal data are present regarding the effect on reproductive toxicity because of the lack of an adequate animal model.
Empliciti should not be used during pregnancy unless the clinical condition of the woman requires treatment with elotuzumab.

The prescribing information leaflets for all medicinal products used in combination with Empliciti must be consulted before starting therapy. When Empliciti is used with lenalidomide or pomalidomide there is a risk of foetal harm, including severe life-threatening human birth defects associated with these agents and the need to follow requirements regarding pregnancy avoidance, including testing and contraception. Lenalidomide and pomalidomide are present in the blood and sperm of patients receiving the medicine. Refer to the prescribing information leaflets for requirements regarding contraception due to presence and transmission in sperm and for additional detail. Patients receiving Empliciti in combination with lenalidomide or pomalidomide should adhere to the pregnancy prevention programme of lenalidomide or pomalidomide respectively.

Breast-feeding
Elotuzumab is not expected to be excreted into human milk. Elotuzumab will be given in combination with lenalidomide or pomalidomide and breast-feeding should be stopped because of the use of lenalidomide or pomalidomide.

Fertility
Studies to evaluate the effect of elotuzumab on fertility have not been performed. Thus, the effect of elotuzumab on male and female fertility is unknown.