Introduction

A Pregnant Woman With Confirmed Varicella Exposure: Managing Risks at 24 Weeks' Gestation

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 Julia W.

PRO-VAR-1205-v1. Julia, a 29-year-old pregnant woman at 24 weeks gestation, initially presented to your office 2 days ago for her first prenatal visit after relocating from another city. During that visit, she reported no known recent exposure to infectious diseases. A review of her immunization history revealed she was unvaccinated against varicella-zoster virus (VZV), and subsequent serologic testing confirmed she lacked immunity to VZV.

Earlier in the morning your office received a call from the mother of a 4-year-old child who had been in the waiting room at the same time as Julia and other patients. The mother reported that her child developed chickenpox (varicella) the day after their visit. The child was unvaccinated against varicella and had displayed no noticeable symptoms at the time of the office visit.

A review of clinic records identified multiple pregnant women, including Julia, who were present in the waiting room during the time of potential exposure. The office promptly notified these women of the exposure and evaluated their varicella immunity status.

Julia now returns to your office, expressing significant concern about the exposure and the potential risks to her pregnancy. She is seeking further guidance on the implications of this exposure and any necessary follow-up care.

Obstetric history: 1 prior vaginal delivery (uneventful).

Medical history: healthy; no chronic conditions.

Allergies: none reported.

Current medications: prenatal vitamins, and occasional acetaminophen for headaches.

Vaccination history: unvaccinated against VZV; up to date with other routine vaccines.

Family and Social History

Julia lives with her husband and five-year-old son.

Physical Examination Notes

Julia is asymptomatic and appears well. No rash, fever, or other systemic symptoms are reported.

Case Description

Julia W. is a 29-year-old pregnant woman, currently at 24 weeks’ gestation, who presents with concerns following confirmed varicella exposure in the waiting room at your office. She remains asymptomatic, with no fever, rash, or other signs of varicella infection. She is seeking further guidance regarding the risks of the exposure and any necessary interventions to protect herself and her unborn baby.

Consultation

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Full transcript below

Transcript · Have you noticed any symptoms?

Doctor: Can you tell me if you’ve noticed any symptoms, such as a rash, fever, or feeling unusually tired, since your last visit?”

Julia: No, I haven’t noticed anything unusual. I feel completely fine.

Doctor: Ok, thank you. That’s helpful to know. Let’s talk about the next steps to keep you protected.

Transcript · Do you have any questions?

Julia: What are the risks if I do end up getting chickenpox?

Doctor: For you, varicella during pregnancy can cause complications like pneumonia, which can be serious. For your baby, exposure to the virus could lead to congenital varicella syndrome if the infection occurs during the first half of pregnancy. Since you’re now at 24 weeks, the risk of congenital varicella syndrome is much lower, but there’s still a possibility of complications, like low birth weight or preterm delivery, if you develop a severe infection.

Julia: Can I still be protected even though I've already been exposed to someone with chickenpox?

Doctor: Yes. Post-exposure prophylaxis is specifically designed for situations like this. It can significantly reduce the risk of developing a severe infection even after exposure, as long as it’s given soon after contact. Since we’re only 2 days out, this is the perfect time to act.

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

Doctor: VARIZIG is approved for Varicella-zoster virus post-exposure prophylaxis. 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, if not, they can usually get it within 24 hours. 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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Complete blood count (CBC)

Prophylaxis without further testing

VZV IgG levels

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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Monitoring for symptoms

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Patient education

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Case Review

The case illustrates a typical scenario involving a pregnant patient at high risk of complications from VZV exposure. Julia, a 29-year-old woman at 24 weeks’ gestation, presents with confirmed susceptibility to VZV (negative IgG serology) and documented close exposure to a child with active chickenpox. She remains asymptomatic at this time.

Julia’s case highlights the importance of prompt recognition and management of VZV exposure during pregnancy. Untreated maternal VZV infection during pregnancy can result in serious complications, including varicella pneumonia in the mother and fetal risks such as congenital varicella syndrome (CVS), low birth weight, and preterm delivery .

In alignment with the latest recommendations from CDC and the ACOG , administration of VARIZIG is strongly recommended within 10 days of exposure. VARIZIG is a safe and effective intervention for reducing the risk and severity of maternal infection. Julia was counselled on the importance of this prophylaxis, and her concerns about fetal health were addressed with reassurance and clear explanations.

While Julia remains asymptomatic, close monitoring for signs of varicella, such as fever, malaise, or rash, is essential over the next 28 days. If symptoms develop, initiation of antiviral therapy with oral acyclovir (800 mg orally, 5 times daily) should be considered to mitigate further complications.

This case reinforces the importance of timely prophylaxis, clear patient education, and vigilant follow-up. Such comprehensive care can effectively reduce the risks for both mother and baby, ensuring optimal outcomes.

Clinical Pearls

Importance of Screening for VZV Immunity

It is important to screen all pregnant women for VZV immunity and a history of chickenpox during their first prenatal visit . This screening can be performed through an immunization history assessment or by ordering a blood test to check for VZV IgG antibodies. Identifying susceptible individuals early allows for appropriate counselling, preventive measures, and management in case of exposure .

Antivirals for Asymptomatic Pregnant Patients Exposed to Varicella

The use of antiviral medications, such as acyclovir, in asymptomatic pregnant patients exposed to VZV is not supported by the current evidence. Antiviral therapy is typically reserved for symptomatic patients to manage active varicella infections. Asymptomatic patients should instead receive post-exposure prophylaxis with VARIZIG to reduce the risk of severe complications .

Congenital Varicella Syndrome and Fetal Risks

CVS is a severe complication of maternal varicella infection, associated with a high mortality rate of approximately 30% within the first few months of life. Survivors face a 15% risk of developing herpes zoster (shingles) between the 2nd and 41st month of life. The risk of CVS is greatest during the first 20 weeks of gestation, emphasizing the need for timely prophylaxis and close monitoring of exposed patients .

Risks of Lack of Vaccination Pre-Pregnancy

Obstetrics-gynecology patients who are not vaccinated against VZV prior to pregnancy are at risk for significant adverse outcomes, including severe maternal varicella pneumonia and fetal complications such as CVS or preterm delivery . Pre-pregnancy vaccination is a critical preventive strategy and should be discussed with all patients of childbearing age. For those already pregnant, post-exposure prophylaxis and counseling are essential to mitigate risks associated with VZV exposure.

You will continue to the evaluation

A Pregnant Woman With Confirmed Varicella Exposure: Managing Risks at 24 Weeks' Gestation · Julia W.

Faculty — Glenn R. Markenson, MD

Supporter — Kamada, Inc / PRO-VAR-1205-v1.

IntroductionConsultationTestsDiagnosesDecisionsCase Review