Agrylin

Agrylin Use In Pregnancy & Lactation

anagrelide

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Use In Pregnancy & Lactation
Use in pregnancy: Teratology studies have been performed in pregnant rats at oral doses up to 900 mg/kg/day (5400 mg/m2/day, 730 times the recommended maximum human dose based on body surface area) and in pregnant rabbits at oral doses up to 20 mg/kg/day (240 mg/m2/day, 32 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to anagrelide HCl.
Nonteratogenic Effects: A fertility and reproductive performance study performed in female rats revealed that anagrelide HCl at oral doses of 60 mg/kg/day (360 mg/m2/day, 49 times the recommended maximum human dose based on body surface area) or higher disrupted implantation and exerted adverse effect on embryo/fetal survival.
A perinatal and postnatal study performed in female rats revealed that anagrelide HCl at oral doses of 60 mg/kg/day (360 mg/m2/day, 49 times the recommended maximum human dose based on body surface area) or higher produced delay or blockage of parturition, deaths of nondelivering pregnant dams and their fully developed fetuses and increased mortality in the pups born. Five women became pregnant while on anagrelide treatment at doses of 1-4 mg/day. Treatment was stopped as soon as it was realized that they were pregnant. All delivered normal, healthy babies. There are no adequate and well-controlled studies in pregnant women. Anagrelide HCl should be used during pregnancy only it the potential benefit justifies the potential risk to the fetus. Anagrelide is not recommended in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be instructed that they must not be pregnant and that they should use contraception while taking anagrelide. Anagrelide may cause fetal harm when administered to a pregnant woman.
Use in lactation: It is not known whether Agrylin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from anagrelide HCl, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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