Intravenous immunoglobulin (IVIG) therapy is a noninvasive procedure in which a purified blood product containing antibodies manufactured from the pooled healthy blood plasma of thousands of donors is injected.
It can be administered to pregnant women or newborns with hemolytic disease of the fetus and newborn (HDFN). In both contexts, IVIG may help prevent your baby’s red blood cells from breaking down and slow the increasing level of bilirubin in your baby’s blood. In best cases, it may delay the need for a blood transfusion.
What is bilirubin?
Bilirubin is a molecular byproduct of the breakdown of hemoglobin, the protein responsible for holding the oxygen transported in red blood cells. It is normally transported to the liver, where it undergoes a transformation called conjugation, and is then excreted from the body through the intestines. Jaundice is caused by the accumulation of bilirubin in the blood, which is known as hyperbilirubinemia.
IVIG therapy in fetuses
When HDFN is diagnosed early in pregnancy, the use of intrauterine blood transfusion (IUT) is considered to hold greater risk of complications, including miscarriage. IVIG may therefore be advised in the interim, to postpone IUT until after 20-22 weeks’ gestation, when it is safer for the fetus.
IVIG can be initiated during or after the end of the first trimester and is administered by an intravenous drip to the pregnant woman.
In some rare cases, IVIG therapy has led to IUT being successfully avoided during pregnancy.
Overall, few side effects have been reported and the procedure is considered safe during pregnancy.
IVIG therapy in newborns
Newborns with anemia, jaundice, and other symptoms of HDFN will commence phototherapy to reduce the amount of bilirubin in their blood. If this isn’t effective, other treatments may need to be considered, such as blood transfusions. Exchange transfusions are highly invasive and are reserved for the most severe cases of anemia.
In recent years, IVIG has gained in popularity as a treatment to delay or avoid exchange transfusions in newborns with HDFN. It is administered through a peripherally inserted central catheter (PICC) in the belly button following, or in tandem with, phototherapy. However, no guarantee can be given that it will have an impact on the need for blood transfusions.
Side effects of IVIG in newborns
While IVIG therapy is generally well-tolerated in newborns, some side effects have been reported. They include:
- Fever
- Headache
- Meningismis (stiff neck, reaction to light)
- Nausea
- Vomiting
- Rash
- Low back pain
- Transient hypotension
- Mild hemolytic anemia
- Tachycardia (increased heart rate)
Rare cases of necrotizing enterocolitis have also been reported. Also, as IVIG is a blood product, there is a very low potential risk for the transmission of viral infectious agents such as HIV and hepatitis B.
Opinions on using IVIG in newborns are mixed
It is worth noting that the use of IVIG for the treatment of HDFN is not currently approved by the Food and Drug Administration (FDA). However, research exists to inform its off-label use.
Medical opinions on the effectiveness of IVIG are mixed, expressed in conflicting studies and publications. In 2022, an international panel of hematologists, neonatologists, and transfusion specialists from the International Collaboration for Transfusion Medicine Guidelines (ICTMG) released new guidelines on the use of IVIG for the treatment of hemolytic disease in newborns. The guidelines do not recommend the use of IVIG in newborns with hemolytic disease, due to a lack of sufficient evidence.
Research into the role of IVIG in the treatment of hemolytic disease in newborns is ongoing.
