Skip to Content
New To Chronic Myeloid Leukemia? Get Information Today >>

Romiplostim Pregnancy and Breastfeeding Warnings

Romiplostim is also known as: Nplate

Romiplostim Pregnancy Warnings

FDA Pregnancy Category : C Use is not recommended unless the benefit outweighs the risk to the developing fetus.

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 use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-800-77-AMGEN (1-800-772-6436). FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Romiplostim Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

The excretion of romiplostim into human milk is unknown. However, romiplostim is comprised of human immunoglobulin and 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.

See references

References for pregnancy information

  1. "Product Information. Nplate (romiplostim)." Amgen USA, Thousand Oaks, CA.

References for breastfeeding information

  1. "Product Information. Nplate (romiplostim)." Amgen USA, Thousand Oaks, CA.

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.