Stelara and Pregnancy
Stelara appears to be safe for women who are expecting. The medication is considered a pregnancy Category B medication, which means that animal studies suggest the drug is safe for pregnant women and their fetuses. However, since Stelara hasn't been studied adequately in pregnant women, talk to your healthcare provider about the risks and benefits in your particular situation.
Is It Safe to Take Stelara When Pregnant?Stelara® (ustekinumab) is a prescription medication approved to treat plaque psoriasis and psoriatic arthritis. Based on the results of animal studies, Stelara appears to be safe for use during pregnancy, although the full risks are currently unknown.
What Is Pregnancy Category B?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 B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies.
Studies have shown that giving even very large doses of Stelara (up to 45 times the recommended equivalent dosage in humans) to pregnant monkeys did not cause any problems for the offspring.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.