Reteplase has been assigned to pregnancy category C by the FDA. Animal data have revealed an abortifacient effect at dosages three times the human dose (per kg basis). Other animal data at doses fifteen times the recommended human dosage (per kg basis) failed to reveal evidence of fetotoxicity, however, maternal genitourinary hemorrhage lead to abortions in mid-gestation. There are no controlled data in human pregnancy. Reteplase should only be used during pregnancy when benefit outweighs risk.

A thorough understanding of the contraindications, relative contraindications, and warnings is recommended before use of this drug or any thrombolytic agent during pregnancy. The most common complication of thrombolytic therapy is bleeding and certain conditions, including pregnancy, can increase this risk.

See references

There are no data on the excretion of reteplase into human milk. Because many drugs are excreted in human milk, the manufacturer recommends caution when reteplase is administered to nursing women.

See references