Invega Sustenna and Pregnancy

Due to potential risks to an unborn child, Invega Sustenna (paliperidone palmitate) is classified as a pregnancy Category C medicine. This means that a healthcare provider should only prescribe it if the benefits to the mother outweigh the risks to the unborn child. The use of antipsychotic drugs like Invega Sustenna during the third trimester has been associated with tremors and other problems in newborns.

Can Pregnant Women Receive Invega Sustenna?

Invega® Sustenna® (paliperidone palmitate) is an injectable prescription medication approved to treat schizophrenia. It is in a class of medications known as antipsychotics. This medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Invega Sustenna 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.
Invega Sustenna did not appear to cause problems when given via intramuscular injection (an injection into the muscle) to pregnant rats in doses up to 10 times the maximum recommended human dose. An oral version of this medication known as paliperidone (Invega®) also did not appear to cause problems when given to pregnant rats at up to 8 times the maximum recommended human dose.
Paliperidone is a metabolite of risperidone (Risperdal®), which means the body changes risperidone into paliperidone. When given to pregnant rats in doses that were less than the maximum recommended human dose, risperidone appeared to increase the risk for miscarriage.
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Invega Sustenna has not been studied in pregnant women. However, when used in the third trimester (the last three months of pregnancy), antipsychotic medicines, such as Invega Sustenna, may increase the risk for withdrawal symptoms and movement-related symptoms (called extrapyramidal symptoms) in newborns. This is based on reports of symptoms in newborns whose mothers took antipsychotics. Some of these reported symptoms have included:
  • Agitation
  • Increased or decreased muscle tone
  • Tremors
  • Sedation
  • Serious breathing problems
  • Feeding difficulty.
In some cases, the symptoms resolved on their own. However, in other cases, the newborns required treatment, including prolonged hospitalization or care in an intensive care unit.
Your healthcare provider may still recommend treatment with Invega Sustenna despite these potential risks. This is because untreated schizophrenia may also be harmful to a pregnant woman and her unborn baby. Therefore, it is important that you not stop treatment without first talking to your healthcare provider. Stopping treatment may cause your symptoms to return.
Pregnancy and Pain

Invega Sustenna Medication Information

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