Is Bharglob (Immunoglobulin) safe to use during pregnancy?

Use of Immunoglobulin (IVIG) in Pregnancy

Intravenous immunoglobulin (IVIG) is safe to use during pregnancy when clinically indicated, with no evidence of increased teratogenicity or adverse fetal outcomes. 1, 2

Safety Profile and Evidence Base

IVIG does not increase the risk of congenital malformations or adverse pregnancy outcomes compared to the general population. The largest cohort study of 370 pregnant women with reproductive failure who received IVIG demonstrated a major fetal anomaly rate of only 1.99%, which is comparable to the general population baseline 2. Most patients in this study started IVIG before 12 weeks of gestation, with 229 continuing treatment beyond the first trimester without safety concerns 2.

Obstetric Complications

Standard obstetric complications occurred at expected rates in IVIG-treated pregnancies 2:

• Preterm birth: 12.0%
• Gestational diabetes: 7.0%
• Preeclampsia: 4.0%
• Placenta previa: 4.3%
• Placental abruption: 1.3%
• Placenta accreta: 1.7%

These rates do not exceed background population frequencies and suggest IVIG does not contribute additional obstetric risk 2.

Established Clinical Indications During Pregnancy

IVIG is recommended as first-line or adjunctive therapy for specific conditions during pregnancy 1:

Strong Indications (Evidence-Based)

• Neonatal alloimmune thrombocytopenia (in utero diagnosis) 1
• Gestational alloimmune liver disease 1
• Hemolytic disease of the fetus and newborn (early-onset severe intrauterine disease) 1
• Immune thrombocytopenia when standard treatment fails or rapid platelet increase is needed 1

Conditional Use in Antiphospholipid Syndrome

IVIG should be conditionally recommended against for routine APS treatment, but may be considered for refractory cases. 3 The American College of Rheumatology strongly recommends against adding IVIG to standard prophylactic heparin and aspirin therapy for obstetric APS, as there are no controlled studies demonstrating benefit 3. However, IVIG may be considered for 1:

• Refractory APS not responding to standard treatment
• Cases where standard treatment is contraindicated
• Catastrophic antiphospholipid syndrome

Conditions Where IVIG Cannot Be Recommended

IVIG therapy cannot be recommended for recurrent pregnancy loss alone 1. Further investigation is needed before IVIG can be endorsed for this indication 1.

Non-Obstetrical Conditions

For non-obstetrical immunologic conditions requiring IVIG (such as primary immunodeficiency, autoimmune diseases, or vasculitis), continue IVIG during pregnancy using the same indications as for non-pregnant patients 1. Historical case reports demonstrate successful pregnancy outcomes in women with common variable hypogammaglobulinemia treated with high-dose IVIG (200 mg/kg weekly during third trimester) 4.

Dosing and Administration

Typical dosing regimens used safely in pregnancy studies 2:

• Mean total dosage: 125.3 grams over the course of pregnancy
• Most patients initiated before 12 weeks gestation
• Treatment commonly continued beyond first trimester when clinically indicated

For specific immunodeficiency states, higher doses may be required (e.g., 200 mg/kg weekly) 4.

Maternal Safety Considerations

Serious maternal side effects from IVIG during pregnancy are rare 1. No cases of viral contamination were reported in the large Korean cohort study 2. The pharmacokinetics of IVIG are well-characterized outside pregnancy, though the precise mechanisms of action and long-term immunologic effects on the fetus remain incompletely understood 1.

Breastfeeding Compatibility

While specific data on IVIG excretion into breast milk are limited, immunoglobulins are large molecules with minimal expected transfer 1. Given the established safety profile during pregnancy and the biological properties of immunoglobulins, breastfeeding is not contraindicated in women receiving IVIG 1.

Common Pitfalls to Avoid

• Do not withhold IVIG for established indications due to pregnancy concerns—the evidence supports safety and efficacy 1, 2
• Do not use IVIG empirically for recurrent pregnancy loss—this indication lacks supporting evidence 1
• Do not add IVIG routinely to standard APS treatment—reserve for refractory cases only 3, 1
• Do not assume IVIG is contraindicated in early pregnancy—most safety data includes first-trimester exposure 2