About VARIZIG®
Reducing Varicella Severity with VARIZIG
VARIZIG [Varicella-Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella (chickenpox) in high-risk patient groups, including immunocompromised children and adults, newborns, and pregnant women.
VARIZIG is intended to reduce the severity of chickenpox infections in these patients.1
VARIZIG is a hyperimmune product that contains antibodies specific to the Varicella-Zoster Virus (VZV), the viral infection known as chickenpox.1
The Centers for Disease Control (CDC) recommends VARIZIG for post-exposure prophylaxis of varicella for persons at high-risk of severe disease who lack evidence of immunity to varicella.
VARIZIG is approved for administration as soon as possible after exposure to VZV, ideally within 96 hours (4 days), and can be given up to 10 days post-exposure.2
Click here for the CDC recommendation for the use of VARIZIG
Indication and Usage1
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, and pregnant women.
VARIZIG administration is intended to reduce the severity of varicella.1
Risk Groups3
Risk Groups for Severe Varicella Zoster Disease and Complications are:
- Immunocompromised children and adults without evidence of immunity to varicella
- Newborns whose mothers have varicella from 5 days before to 2 days after delivery
- Premature babies and infants < 1 year of age exposed to varicella or herpes zoster
- Pregnant women without evidence of immunity to varicella
Immunocompromised Patients without Immunity to Varicella4
Immunocompromised Patients without Immunity to Varicella4
Immunocompromised children and adults are at increased risk for severe disease following infection with varicella zoster virus (VZV). This includes a heightened risk of visceral dissemination (e.g., varicella-related pneumonia, encephalitis, hepatitis), secondary bacterial infections, and mortality. Even those who previously received two doses of the varicella vaccine face significant risks due to declining immunity caused by immunosuppressive therapy.
Advances in cancer treatments, new immunosuppressant medications, and higher rates and improved survival of organ transplant recipients undergoing prolonged immune suppression have contributed to the growing number of immunocompromised individuals. Varicella vaccination is contraindicated in immunocompromised patients, including those with malignant conditions and those receiving high-dose systemic immunosuppressive therapy.
Passive immunity with Varicella Zoster Immune Globulin has been shown to reduce the severity of varicella infection and is widely accepted as the standard prevention strategy for exposed immunocompromised individuals.
Infants without Immunity to Varicella
Infants born to pregnant women who develop varicella around the time of delivery (within 5 days before delivery or within 48 hours after delivery) and born to mothers without evidence of immunity are at risk for severe neonatal varicella because they lack protective transplacental VZV antibodies, have impaired cellular immune response, and could have been exposed to a high transplacental viral load in utero.5
Pre-term infants born to mothers without evidence of immunity or are < 28 weeks of gestation are at higher risk due to age-related impairment in cellular immune response and/or insufficient time to acquire maternal IgG antibodies. 5
VARIZIG is recommended for post-exposure prophylaxis to prevent or attenuate varicella in high-risk individuals, including 1 infants who are <28 weeks’ gestational age, 2 infants weighing <1000 g, hospitalized neonates ≥28 weeks’ gestational age whose mothers lack immunity to varicella, and infants whose mothers develop varicella within 5 days before delivery or within 48 hours after delivery.5
Pregnant Women without Immunity to Varicella
Pregnant women should be evaluated in the same manner as other adults; however, because such women are at higher risk for severe varicella and complications, VARIZIG should be strongly considered in high risk pregnant women who have been exposed to VZV.6
Administration of VARIZIG to susceptible, pregnant women has not been found to prevent viremia, fetal infection, congenital varicella syndrome, or neonatal varicella. The primary indication for VARIZIG in susceptible pregnant women is to prevent complications of varicella in the mother, rather than to protect the fetus.1
Dosing 1
VARIZIG dosing is based on body weight.
Administer a single dose of VARIZIG intramuscularly as recommended in the following table:
Please scroll right-left to see the whole table
Weight of Patient
Kilograms
≤ 2.0
2.1-10.0
10.1-20.0
20.1-30.0
30.1-40.0
≥ 40.1
Pounds
≤ 4.4
4.5-22.0
22.1-44.0
44.1-66.0
66.1-88.0
≥ 88.1
VARIZIG Dose
International Units
62.5
125
250
375
500
625
Number of Vials
0.5
1
2
3
4
5
Volume to administer* (milliliters)
0.6
1.2
2.4
3.6
4.8
6.0
* Extractable volumes are confirmed using 21 gauge needle as per USP General Chapters <1> INJECTIONS
- Minimum dose | 62.5 International Units for small infants ≤2 kilograms body weight
- Maximum dose | 625 International Units should be administered for all patients > 40 kilograms in body weight
Administration1
For intramuscular use only.
- Divide the intramuscular dose and administer in two or more injection sites, depending on patient size. Do not exceed 3 milliliters per injection site.
- Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant.
- To prevent the transmission of infectious agents from one person to another, use a new disposable sterile syringe and needle for each individual patient.
Storage
& Handling 1
Storage & Handling 1
Store VARIZIG at at 2 to 8°C (36 to 46°F) Do not freeze.
Do not use after expiration date.
References: [1] VARIZIG [package insert]. Kamada Inc September 2022. [2] CDC. Updated Recommendations for Use of VARIZIG – United States, 2013. [3] 3. CDC Clinical Overview of Chickenpox (Varicella). [4] Varicella-zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program. Gans, H., Chemaly, R.F. Varicella-zoster immune globulin (human) (VARIZIG) in immunocompromised patients: a subgroup analysis for safety and outcomes from a large, expanded-access program. BMC Infect Dis 21, 46 (2021).
[5] Safety and varicella outcomes in utero-exposed newborns and preterm infants treated with varicella-zoster immune globulin (VARIZIG): A subgroup analysis of an expanded-access program. Duchon JM, Levin MJ, Gershon AA. Safety and varicella outcomes in in utero-exposed newborns and preterm infants treated with varicella-zoster immune globulin (VARIZIG): a subgroup analysis of an expanded-access program. J Pediatric Infect Dis Soc. 2019.