Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There is very limited amount of data from the use of vincristine in pregnant patients. Studies in animals have shown teratogenicity and other reproductive toxicity (see section 5.3). Based on results from animal studies and the pharmacodynamics of the substance, vincristine should not be used during pregnancy, particularly during the first trimester. If pregnancy occurs during treatment with vincristine the patient must be informed about the possible dangers to the fetus.

Contraceptive measures should be taken by both the male and the female patients during the treatment and for 6 months after discontinuation of the treatment (also see section 4.4).
If pregnancy occurs during treatment, the patient should be informed about the risks for the unborn child and should be monitored carefully.

Vincristine can have genotoxic effects. Therefore, the possibility of genetic counselling should be considered if pregnancy occurs during therapy with vincristine and is also recommended for patients wishing to have children after therapy.

Breast-feeding It is unknown whether vincristine is excreted in human breast milk. Breast-feeding must be discontinued during treatment with vincristine sulfate.

Fertility
Treatment with vincristine may cause irreversible infertility. The reversibility of these antifertility effects depends on the age of the patient and the dose administered. Commonly, azoospermia has been observed in men who were treated with a chemotherapy combination consisting of vincristine and prednisone with cyclophosphamide or mechlorethamine and procarbazine. Less commonly, amenorrhea has been observed in women who were treated with vincristine- containing chemotherapy.
Patients should be consulted about future fertility prospects. Male patients have to be consulted about sperm preservation.