Mvasi Use In Pregnancy & Lactation

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