Arzerra and Pregnancy
If you are a woman undergoing treatment with Arzerra (ofatumumab), it is important to know the potential risks this drug may pose to an unborn child. Arzerra is a pregnancy Category C medicine because it appeared to cause problems when given to pregnant animals. This medicine should only be taken if the benefits to the mother outweigh the risks to her unborn child.
Can Pregnant Women Receive Arzerra?Arzerra® (ofatumumab) is a prescription medication that belongs to a group of medicines known as monoclonal antibodies. It is approved to treat a certain type of leukemia. Based on the results of animal studies, this drug may not be safe for use during pregnancy, although the full risks are currently unknown.
What Is Pregnancy Category C?Arzerra 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.
Arzerra has not been adequately studied in pregnant women. In animal studies, the drug did not cause birth defects when given to pregnant monkeys. However, it did decrease the weight of the spleen and the number of B lymphocytes (a type of white blood cell commonly called B cells) in the monkey fetuses.
It is not entirely known how the reduced B cell count from Arzerra would affect the monkey offspring, or how long it would take for the B cell count to improve. However, because B cells help fight viruses and bacteria, a reduction in B cells could temporarily increase the risk for infections. This could potentially be dangerous, especially since pregnancy by itself suppresses the immune system and increases the risk for infections.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child. Because leukemia is a serious illness, your healthcare provider may recommend the medication even if you are pregnant.
Arzerra is associated with potentially dangerous side effects, including the risk for infections and infusion reactions (see Arzerra Warnings and Precautions). If a pregnant woman experiences these side effects, it could be harmful to her unborn child.