Dasatinib Pregnancy and Breast Feeding Warnings

Dasatinib is also known as: Sprycel

Overview

Do not use Dasatinib if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Dasatinib is found in breast milk. Do not breast-feed while taking Dasatinib .

Dasatinib Pregnancy Warnings

Dasatinib has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryo-fetal toxicities including skeletal malformations at multiple sites (scapula, humerus, femur, radius, ribs, clavicle), reduced ossification (sternum; thoracic, lumbar, and sacral vertebrae; forepaw phalanges; pelvis; and hyoid body), edema, microhepatia and fetal death. There are no controlled data in human pregnancy. Dasatinib is not recommended for use in women who are pregnant or contemplating pregnancy.

Sexually active male or female patients taking dasatinib should use adequate contraception. The effects of dasatinib on human male and female fertility have not been studied. However, results of repeat-dose toxicity studies in multiple species indicate the potential for dasatinib to impair reproductive function and fertility. Effects evident in male animals included immature prostate, seminal vesicle, and testis as well as reduced size and secretion of seminal vesicles. Animal tests have also reported that the administration of dasatinib resulted in uterine inflammation and mineralization, cystic ovaries, and ovarian hypertrophy.

Dasatinib Lactation Warnings

There are no data on the excretion of dasatinib into human milk. The manufacturer recommends that women who are taking dasatinib do not breast-feed.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.