Avegra

Avegra Use In Pregnancy & Lactation

bevacizumab

Manufacturer:

JSC BIOCAD

Distributor:

Biogenetech

Marketer:

Biogenetech
Full Prescribing Info
Use In Pregnancy & Lactation
Women of childbearing potential: Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
Pregnancy: There are no clinical trial data on the use of bevacizumab in pregnant women. Studies in animals have shown reproductive toxicity including malformations. IgGs are known to cross the placenta, and bevacizumab is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy. 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 Adverse Reactions). Avegra is contraindicated in pregnancy (see Contraindications).
Breast-feeding: 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 must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of Avegra.
Fertility: Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility. In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with 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 the majority of patients. Long term effects of the treatment with bevacizumab on fertility are unknown.
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