About Panzyga

What is IVIG?

IVIG (short for intravenous immunoglobulin) is a type of intravenous (IV) therapy that helps support the immune system. IVIG contains immunoglobulins (a type of immunecell) from the blood of healthy donors. IVIG is often used for conditions like primary and secondary immune deficiency, Guillain-Barre syndrome, Lupus, and others.

An IVIG therapy called Panzyga is now being researched in children presenting with symptoms of pediatric acute-onset neuropsychiatric syndrome (PANS/PANDAS).

What is Panzyga?

Panzyga is an investigational IVIG treatment for PANS/PANDAS aimed to help reduce the severity of symptoms associated with PANS/PANDAS disorder. It is made using a highly technical filtration process to prevent the spread of any bloodborne illnesses. Panzyga is approved by the FDA for other conditions, but it is not currently approved for addressing PANS symptoms in children.

Panzyga is being researched in comparison with placebo (no active ingredients) in the ProPANS IVIG clinical trial.

Adverse Events experienced previously with Panzyga

Some adverse events reported with IVIG drug administration are:

• Headaches (Common)
• Nausea (Common)
• Thromboembolic events (TEEs) (Rare)
• Hemolytic transfusion reactions (HTRs) (Rare)

For a full list of possible side effects, please refer to the package insert

Will I receive the study medication?

All participants will receive the study drug and placebo (no active ingredients). Participants will be randomly assigned to receive the study drug in either the first or second half of the study.

This drug has been FDA approved to address other conditions, but it is not FDA approved for the use of addressing PANS/PANDAS symptoms in children.

What is an "investigational medicine"?

Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical trials like ProPANS IVIG clinical trial.