L-Asgen 10,000 IU Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Women of childbearing potential have to use effective contraception and avoid becoming pregnant while being treated with asparaginase containing chemotherapy and for 7 months following completion of treatment. Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation. A method other than oral contraceptives should be used in women of childbearing potential (see Precautions). Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase and for 4 months following completion of treatment.
Pregnancy: There are no data on the use of asparaginase in pregnant women. No reproduction studies in animals with asparaginase were performed but studies with asparaginase preparations in mice, rats, chicken and rabbits have shown embryotoxic and teratogenic effects (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on results from animal studies and its mechanism of action, L-Asgen 10,000 IU should not be used during pregnancy unless the clinical condition of the woman requires treatment with asparaginase.
Breast-feeding: It is unknown whether asparaginase is excreted into human breast milk. Because potential serious adverse reactions may occur in breast-feeding infants, L-Asgen 10,000 IU should be discontinued during breast-feeding.
Fertility: No human data on the effect of asparaginase on fertility are available.