Varicella-Zoster Immune Globulin (Human)

Dosage Forms & Strengths

intramuscular injection

• 125 IU/vial (lyophilized powder)
• 100 IU/mL (after reconstitution)

Varicella, Postexposure Prophylaxis

Indicated for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals after exposure

625 units IM within 10 days after exposure (ideally within 4 days [96 hr])

Consider a second full dose for high risk patients who have additional exposures to varicella >3 weeks after initial administration

Dosing Considerations

High risk groups include

• Immunocompromised patients without evidence of immunity
• Pregnant women without evidence of immunity

Reduces severity only

• There is no convincing evidence that varicella zoster immune globulin (VZIG) reduces the incidence of chickenpox infection after exposure to VZV
• There is no convincing evidence that established infections with VZV can be modified by VZIG administration
• There is no indication for the prophylactic use of VZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation

Administration

Inject IM 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 gluteal region is used, only use the upper, outer quadrant

Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site

Dosage Forms & Strengths

intramuscular injection

• 125 IU/vial (lyophilized powder)
• 100 IU/mL (after reconstitution)

Varicella, Postexposure Prophylaxis

Indicated for reducing the severity of chicken pox (varicella zoster virus) infections in high risk individuals after exposure

125 IU/10kg IM; not to exceed 625 IU/dose

Administer within 10 days after exposure (ideally within 4 days [96 hr])

<2 kg: 62.5 IU IM

2.1-10 kg: 125 IU IM

10.1-20 kg: 250 IU IM

20.1-30 kg: 375 IU IM

30.1-40 kg: 500 IU IM

>40 kg: 625 IU IM

Consider a second full dose for high risk patients who have additional exposures to varicella >3 weeks after initial administration

Dosing Considerations

High risk groups include

• Immunocompromised patients without evidence of immunity
• Newborn infants whose mothers have signs and symptoms of varicella around the time of delivery (ie, 5 days before to 2 days after)
• Hospitalized premature infants born at 28 weeks of gestation or greater whose mothers do not have evidence of immunity to varicella
• Hospitalized premature infants born at <28 weeks of gestation or who weigh 1 kg or less at birth, regardless of their mothers' evidence of immunity to varicella

Reduces severity

• There is no convincing evidence that varicella zoster immune globulin (VZIG) reduces the incidence of chickenpox infection after exposure to VZV
• There is no convincing evidence that established infections with VZV can be modified by VZIG administration
• There is no indication for the prophylactic use of VZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone marrow transplantation

Administration

For IM use only

Depending on patient size, divide the IM dose and administer in 2 or more injection sites; not to exceed 3 mL/injection site

Inject IM 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 gluteal region is used, only use the upper, outer quadrant

Infants/small children: Administer IM in anterolateral aspect of thigh

1-10%

Injection site pain (2%)

Headache (2%)

Frequency Not Defined

Chills

Fatigue

Rash

Nausea

Thrombosis

Mechanism of Action

Solvent/detergent-treated sterile lyophilized preparation of purified human immune globulin G (IgG) containing antibodies to varicella zoster virus

Provides passive immunization for nonimmune individuals exposed to varicella zoster virus, thereby reducing the severity of varicella infections

Absorption

Peak plasma time: 4.5 days

Peak plasma concentration: 136 mIU/mL

AUC: 2472-4087 mIU•day/mL (24-84 days)

Elimination

Half-life: 26.2 days

Total body clearance: 0.204 mL/day

Use varicella-zoster immune globulin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.