Navelbine Use In Pregnancy & Lactation

Pregnancy: There are inadequate data on the use of vinorelbine in pregnant women. In reproductive studies conducted in animals, vinorelbine was embryotoxic and teratogenic. Based on the results of these animal studies and the pharmacological action of the medicinal product there is a potential risk of embryonic and foetal abnormalities.
Vinorelbine must not be used during pregnancy unless the expected individual benefit manifestly exceeds the potential risks. If a patient becomes pregnant during treatment she must be informed of the risks to the unborn child and monitored carefully. The possibility of genetic counselling should also be considered.
Women of child-bearing potential: Women of child-bearing potential must be using an effective contraception during treatment and for three months after treatment is stopped.
Lactation: It is not known whether vinorelbine is excreted into human breast milk.
The excretion of vinorelbine into milk has not been studied in animals.
It is not possible to exclude a risk during breastfeeding.
As a result, breastfeeding must be stopped before beginning treatment with vinorelbine.
Fertility: Men treated with vinorelbine must be warned not to conceive a child during treatment and for at least 3 months after treatment.
Before treatment it is recommended that sperm storage be considered because of the risk of irreversible infertility following treatment with vinorelbine.