Orthoclone OKT3 and Pregnancy

No research has been done on using Orthoclone OKT3 (muromonab-CD3) during pregnancy, so it is unknown if this drug crosses the placenta or if it would harm an unborn child. Because this medicine is associated with potentially dangerous and even fatal complications, the manufacturer of the drug recommends that pregnant women not receive Orthoclone OKT3 unless it is clearly needed.

Can Pregnant Women Receive Orthoclone OKT3?

Orthoclone OKT®3 (muromonab-CD3) is a prescription medication approved to treat kidney, liver, and heart transplant rejection, which occurs when the immune system recognizes a transplanted organ as foreign and tries to get rid of it. At this time, it is unknown whether this medication is safe for use during pregnancy.

What Is Pregnancy Category C?

Orthoclone OKT3 is classified as a pregnancy Category C drug. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
This medication has not been studied in pregnant women or in pregnant animals. Therefore, there is little information available about the possible effects of Orthoclone OKT3 on a developing fetus.
What is known is that Orthoclone OKT3 is a synthetic (laboratory-made) form of immunoglobulin G (IgG) antibody, a protein made by the immune system. IgG antibodies normally cross the placenta to an unborn child. Therefore, it is reasonable to expect that a developing fetus would be exposed to at least some amount of Orthoclone OKT3. Whether the medicine would be harmful to the fetus is unknown.
Orthoclone OKT is associated with potentially serious side effects, including an increased risk for infections. In addition, many people develop a reaction to the medicine after the first few doses. This reaction usually causes high fever and other "flu-like" symptoms, but can also lead to life-threatening symptoms in rare cases. These side effects could be harmful to a developing fetus.
The manufacturer of the medicine recommends it only be used in pregnant women if clearly needed. Because transplant rejection is a serious medical problem, a healthcare provider may recommend that a pregnant woman use this drug if no other treatments are an option.
Pregnancy and Pain

Orthoclone OKT3 Drug Information

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