Introduction

Late-Term Varicella Infection in Pregnancy

Important information

VARIZIG highlights of prescribing information, available at https://varizig.com/wp-content/uploads/2024/09/VARIZIG_Pl.pdf

Indication and Usage

VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for post-exposure prophylaxis in high-risk individuals. High-risk groups include: immunocompromised children and adults, newborns of mothers with varicella shortly before or after delivery, premature infants, neonates and infants less than one year of age, adults without evidence of immunity, pregnant women.

VARIZIG administration is intended to reduce the severity of varicella.

Important Safety Information

VARIZIG contains trace amounts of IgA. Individuals known to have anaphylactic or severe systemic (hypersensitivity) reactions to human immune globulin preparations should not receive VARIZIG. IgA-deficient patients with antibodies against IgA and a history of hypersensitivity may have an anaphylactoid reaction. Thrombotic events may occur during or following treatment with immune globulin products. Administer VARIZIG intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, only administer VARIZIG if the expected benefits outweigh the potential risks. Severe hypersensitivity reactions may occur following VARIZIG administration. In case of hypersensitivity, discontinue administration of VARIZIG immediately and provide appropriate treatment. Because VARIZIG is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease agent, and, theoretically, the Creutzfeldt-Jakob disease agent.

The most serious adverse drug reactions observed in clinical trials for all subjects and patients include pyrexia, nausea, and vomiting. The most common adverse drug reactions observed in clinical trials for all subjects and patients were injection site pain, headache, chills, fatigue, rash, and nausea.

Please see full Prescribing Information for complete prescribing details.

To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

VARIZIG is a registered trademark of Kamada Ltd. Kamada Inc., 221 River St, Hoboken, NJ 07030. Tel. 1-833-779-2614 ©2024 Kamada Inc.

History of Present Illness

Welcome. Your patient today is Meredith H.

PRO-VAR-1202-v1. Meredith is a 32-year-old woman (gestational age: 35 weeks) with an uncomplicated pregnancy who is scheduled for a cesarean section at 39 weeks (she had a prior c-section and requested a repeat). Two weeks before the planned cesarean section her husband is diagnosed with active varicella. She contacts her obstetrician since she is concerned about her risk of infection and potential effects on the baby. She also presents with signs of preeclampsia without severe features, including proteinuria.

In her first trimester, you inquired about her history regarding varicella exposure. She confirmed that she had neither received the varicella vaccine nor contracted chickenpox in the past. Given this information, you ordered a blood test to assess her immunity. The results indicated that she was negative for varicella immunity.

Given the timing of the infection in late pregnancy, there is concern for potential neonatal varicella, which can be severe.

Family and Social History

The patient lives at home with her husband and 2 young children. Her husband was recently diagnosed with active varicella, prompting her current concern.

Physical Examination Notes

Vitals

Blood pressure: 140/92 mmHg

Respiratory rate (RR): 18

Heart rate (HR): 88 bpm

Temperature: 37.0 °C (98.6 °F)

Assessment: the findings are consistent with preeclampsia without severe features in a patient with recent varicella exposure.

Consultation

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Full transcript below

Transcript · How are you Meredith?

Meredith: I’m really worried. My husband was diagnosed with varicella just a few days ago.

Doctor: Thank you for letting me know. That’s important information. In your first trimester, I asked about your history regarding varicella exposure. You confirmed that you had neither received the varicella vaccine nor contracted chickenpox in the past. Given this information, we ordered a blood test to assess your immunity. The results indicated that you were negative for varicella immunity. Since you may not have immunity, your exposure to varicella could pose a risk to you and your baby, especially this late in pregnancy. We’ll take steps to reduce that risk by giving you post-exposure prophylaxis. This should help protect you from developing severe varicella.

Meredith: How do I actually get the post-exposure prophylaxis?

Doctor: In the past, it may have been challenging to get VARIZIG, but that’s no longer an issue. Your local pharmacy should have it in stock, or if not, they can usually get it within 24 hours, if not please let me know right away. So I’ll write you a prescription, and once you pick it up, you’ll bring it back here, and I’ll administer it for you.

Tests

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Physical examination

Proceed without antibody testing

Varicella-zoster antibody test

Diagnoses

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Existing Diagnoses

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Decisions

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Medication Selection

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Non-Medication Orders

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Communication with the neonatal team

Next steps

Follow-up

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Case Review

The patient is a 32-year-old woman at 35 weeks of gestation with a history of preeclampsia without severe features, characterized by proteinuria (1+ on dipstick). She has no history of chickenpox or varicella vaccination, and blood testing confirmed her lack of immunity, placing her at increased risk for severe complications from varicella infection. Two weeks before her scheduled cesarean section, her husband was diagnosed with active varicella, resulting in significant exposure to VZV.

Given her late-stage pregnancy and lack of VZV immunity, the patient is at increased risk for severe maternal infection and potential neonatal varicella. She remains asymptomatic, with no fever, rash, or malaise—however, her immunologic vulnerability due to pregnancy warrants prompt intervention.

The patient was prescribed post-exposure prophylaxis with VARIZIG and is being closely monitored for signs of VZV infection. Coordination with the neonatal care team has also been initiated to prepare for possible complications in the newborn.

Expert Consensus

  • Development of varicella during pregnancy, can result in serious adverse outcomes such as congenital varicella syndrome, maternal VZV pneumonia, and neonatal varicella infection, all of which can lead to feto-maternal morbidity and mortality .
  • Close household contact with individuals actively infected with VZV, such as a spouse with chickenpox, represents a significant transmission risk. These exposures require urgent evaluation and prophylactic intervention to minimize maternal and neonatal morbidity .
  • The absence of prior varicella vaccination or history of chickenpox leaves pregnant individuals without immunity, further increasing susceptibility .
  • Post-exposure prophylaxis with VARIZIG is the standard of care for pregnant women exposed to VZV who lack immunity . Administering VARIZIG as soon as possible, ideally within 96 hours of exposure (but can be administered up to 10 days following exposure), significantly reduces the severity of maternal infection and lowers the risk of neonatal varicella .
  • Neonatal varicella management includes isolation and postexposure prophylaxis with VARIZIG within 10 days of exposure, especially for neonates exposed around delivery, preterm infants with significant exposure, or those <28 weeks or <1,000 g at birth. Healthy term neonates exposed postnatally generally do not require prophylaxis. If VARIZIG is unavailable, IVIG or acyclovir may be used .
  • Due to both maternal and fetal risks from preeclampsia, the delivery plan should not be altered due to her exposure to varicella. Delivery should be based on the recommendations for pregnancies complicated by preeclampsia without severe features. So, in this case, her delivery, by repeat cesarean as she requested, would be at 37 weeks. Her exposure to varicella should not influence this decision.
You will continue to the evaluation

Late-Term Varicella Infection in Pregnancy · Meredith H.

Faculty — Glenn R. Markenson, MD

Supporter — Kamada, Inc / PRO-VAR-1202-v1.

IntroductionConsultationTestsDiagnosesDecisionsCase Review