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Interferon beta-1b Pregnancy and Breastfeeding Warnings

Interferon beta-1b is also known as: Betaseron, Extavia

Overview

Do not use Interferon Beta-1b Solution 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 Interferon Beta-1b Solution is found in breast milk. If you are or will be breast-feeding while you use Interferon Beta-1b Solution, check with your doctor. Discuss any possible risks to your baby.

Interferon beta-1b Pregnancy Warnings

A recently published consensus conference states that interferon beta-1b is contraindicated in pregnant or nursing women or those who are actively attempting to become pregnant. Therapy should be stopped in patients who become pregnant while taking interferon beta-1b. It may be most prudent to start (or restart) therapy as soon as possible after delivery or weaning to help decrease the increased risk of exacerbations during the postpartum period. Findings of right incomplete double renal pelvis and ureter in a 1-year-old child is believed to be associated to the interferon therapy used by the mother up to 2.5 months before her pregnancy. A Betaseron (R) Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnant women exposed to interferon beta-1b. Physicians are encouraged to obtain information at www.BetaseronPregnancyRegistry.com and register patients by calling 1-800-478-7049 (USA).

Interferon beta-1b has been assigned to pregnancy category C by the FDA. Animal studies of interferon beta-1b have failed to reveal a teratogenic effect, but abortifacient activity has been demonstrated at higher than recommended doses. Spontaneous abortion was reported in 4 women during a trial for the treatment of multiple sclerosis. There are no controlled data in human pregnancy. Interferon beta-1b is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. The manufacturer recommends discontinuing therapy if the patient becomes or plans to become pregnant while taking interferon beta-1b.

Interferon beta-1b Breastfeeding Warnings

There are no data on the excretion of interferon beta-1b into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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