Romiplostim Pregnancy and Breastfeeding Warnings

Romiplostim is also known as: Nplate

Romiplostim Pregnancy Warnings

Romiplostim has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of thrombocytosis, postimplantation loss, and an increase in mortality. There are no controlled data in human pregnancy. Romiplostim should only be given during pregnancy when benefits outweigh risks.

A pregnancy registry has been established to collect information about the effects of romiplostim use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the romiplostim pregnancy registry by calling 1-877-romiplostim1 (1-877-675-2831).

Romiplostim Breastfeeding Warnings

There are no data on the excretion of romiplostim into human milk. However, human IgG is excreted into human milk. Published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from romiplostim, a decision should be made whether to discontinue nursing or to discontinue romiplostim, taking into account the importance of romiplostim to the mother and the known benefits of nursing.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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 material 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 combination thereof in no way should be construed to indicate that the drug or 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 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.