Abatacept Pregnancy and Breastfeeding Warnings
Abatacept is also known as: Orencia
Abatacept Pregnancy Warnings
Abatacept has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Abatacept crosses the placenta. There are no controlled data in human pregnancy. Abatacept is only recommended for use during pregnancy when benefit outweighs risk.
Rats treated with abatacept every three days during early gestation throughout the lactation period showed no adverse effects in the offspring at doses up to 45 mg/kg (3-fold a human 10 mg/kg dose based on AUC). At a dose of 200 mg/kg (11-fold a human 10 mg/kg dose based on AUC) alterations of immune function consisted of a 9-fold increase in the T-cell dependent antibody response in female pups and inflammation of the thyroid in one female pup out of 10 males and 10 females evaluated. It has not been determined if these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept. A pregnancy registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to abatacept. Healthcare professionals are encouraged to register patients and patients may also enroll themselves by calling 1-877-311-8972.
Abatacept Breastfeeding Warnings
There are no data on the excretion of abatacept into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, including possible effects on the developing immune system, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
- Abatacept use while Breastfeeding (in more detail)
- abatacept Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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 or 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.