Women of child-bearing potential/Contraception in males and females: Women: The pregnancy status of child-bearing women should be verified prior to initiating therapy with BLENREP.
Women of child-bearing potential should use effective contraception during treatment with BLENREP and for 4 months after the last dose.
Men: Men with female partners of child-bearing potential should use effective contraception during treatment with BLENREP and for 6 months after the last dose.
Pregnancy: There are no data from the use of BLENREP in pregnant women.
Based on the mechanism of action of the cytotoxic component monomethyl auristatin F (MMAF), belantamab mafodotin can cause embryo-foetal harm when administered to a pregnant woman (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human immunoglobulin G (IgG) is known to cross the placenta; therefore, belantamab mafodotin has the potential to be transmitted from the mother to the developing foetus (see Pharmacology: Toxicology: Preclinical safety data under Actions).
BLENREP should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus. If a pregnant woman needs to be treated she should be clearly advised on the potential risk to the foetus.
Breast-feeding: It is not known whether belantamab mafodotin is excreted into human milk. Immunoglobulin G (IgG) is present in human milk in small amounts. Since belantamab mafodotin is a humanised IgG monoclonal antibody, and based on the mechanism of action, it may cause serious adverse reactions in breast-fed children. Women should be advised to discontinue breast-feeding prior to initiating treatment with BLENREP and for 3 months after the last dose.
Fertility: Based on findings in animals and the mechanism of action, belantamab mafodotin may impair fertility in females and males of reproductive potential (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Therefore, women of childbearing potential who may desire children in the future should be counselled prior to therapy regarding the option of having eggs frozen before treatment. Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.