Versavo Use In Pregnancy & Lactation

Female and Male of Reproductive Potential: Fertility: Bevacizumab may impair female fertility. Women of child-bearing potential should be advised of fertility preservation strategies prior to starting treatment with bevacizumab (see Precautions and Clinical Studies under Adverse Reactions).
Repeat dose safety studies in animals have shown that Bevacizumab may have an adverse effect on female fertility (see Pharmacology: Toxicology: Non-clinical Safety: Impairment of fertility under Actions). A sub study with 295 premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group. After discontinuation of bevacizumab treatment, ovarian function recovered in majority of patients. Long term effects of the treatment with bevacizumab on fertility are unknown.
Contraception: In women with child-bearing potential, appropriate contraceptive measures should be use during treatment with Bevacizumab. Based on pharmacokinetic considerations, contraceptive measures should be used for at least 6 months following the last dose of bevacizumab.
Pregnancy: Angiogenesis has been shown to be critically important to fetal development. The inhibition of angiogenesis following administration of Versavo could result in an adverse outcome of pregnancy.
There are no adequate and well-controlled studies in pregnant women (see Pharmacology: Toxicology: Non-clinical Safety: Reproductive Toxicity under Actions). IgGs are known to cross the placental barrier and Bevacizumab may inhibit angiogenesis in the fetus. In post marketing setting, cases of fetus abnormalities in women treated with Bevacizumab alone or combination with known embryotoxic chemotherapeutics have been observed (see Post marketing experience under Adverse Reactions). Therefore, Bevacizumab should not be administered during pregnancy. It is not known whether Bevacizumab is excreted in human milk. As maternal IgGs is excreted in milk and bevacizumab could harm infant growth and development, woman should be advised to discontinue nursing during treatment with bevacizumab and not to breast feed for at least 6 months after the last dose of bevacizumab.
Labour and Delivery: Not applicable.
Lactation It is not known whether Bevacizumab is excreted in human milk. As maternal IgGs is excreted in milk and bevacizumab could harm infant growth and development, woman should be advised to discontinue nursing during treatment with bevacizumab and not to breast feed for at least 6 months after the last dose of bevacizumab.