Campath and Pregnancy
As a pregnancy Category C drug, Campath (alemtuzumab) may be used under certain circumstances during pregnancy. However, the full risks are unclear, and animal studies suggest that the drug may cause problems. For women of childbearing potential, the manufacturer of Campath recommends using adequate birth control not only during treatment, but for four months after treatment ends.
Campath® (alemtuzumab) is a prescription medication approved to be used alone for the treatment of B-cell chronic lymphocytic leukemia. Campath may not be safe for use during pregnancy, although the full risks are not known.
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 studied in pregnant humans but do appear to cause harm to the fetus 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.
Campath has not been adequately studied in pregnant women or in animals. Therefore, it is unknown whether the medicine may harm an unborn child if used by a pregnant woman.
Campath is a synthetic, or manufactured, form of immunoglobulin G (IgG) antibody, a protein made by the immune system. IgG antibodies are known to cross the placenta to an unborn child. Therefore, it is likely that the developing fetus would be exposed to Campath.
Furthermore, this medication is associated with potentially dangerous side effects, including risk for serious infections. If a pregnant woman develops a serious infection, it could be harmful to her unborn child.
The manufacturer recommends that Campath only be used in pregnant women if clearly needed. The drug may be given to pregnant women if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. Because leukemia is a serious illness, your healthcare provider may recommend this medication even if you are pregnant.
Women and men of childbearing potential should use an effective form of birth control during treatment and for at least six months after receiving the last Campath dosage. Talk to your healthcare provider about possible effective birth control options for you.