VARIZIG

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VARIZIG

Classes

Varicella Zoster Antitoxins and Immunoglobulins

Administration
Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if the solution is cloudy or contains particulates.[52697]

Intramuscular Administration

Preparation:
Calculate the number of vials needed for the dose.
Bring vial(s) to room temperature prior to use.
Each vial is for single use only and contains a minimum potency of 125 International Units in 1.2 mL.[52697]
 
Intramuscular injection:
Divide the calculated dose and administer in 2 or more injection sites, depending on patient size. DO NOT exceed 3 mL per injection site.
Inject into the deltoid muscle or the anterolateral aspects of the upper thigh. Do not use the gluteal region as a routine injection site. If the gluteal region is used, only use the upper, outer quadrant because of the risk of sciatic nerve injury.[52697]

Adverse Reactions
Severe

serum sickness / Delayed / 0-1.0
coagulopathy / Delayed / 0-1.0
intracranial bleeding / Delayed / 0-1.0
disseminated intravascular coagulation (DIC) / Delayed / 0-1.0
thrombosis / Delayed / 0-1.0
intraventricular hemorrhage / Delayed / 0-1.0
anaphylactic shock / Rapid / Incidence not known

Mild

injection site reaction / Rapid / 3.0-3.0
headache / Early / 2.0-2.0
pruritus / Rapid / 0-1.0
fatigue / Early / 1.0-1.0
vesicular rash / Delayed / 0-1.0
urticaria / Rapid / 0-1.0
chills / Rapid / 1.0-1.0
rash / Early / 1.0-1.0
nausea / Early / 1.0-1.0
infection / Delayed / Incidence not known

Common Brand Names

VARIZIG, VARIZIG Powder

Dea Class

Rx

Description

Purified human immune globulin G (IgG) containing antibodies to varicella-zoster virus (anti-VZV)
For post-exposure prophylaxis of varicella in high risk individuals
Product may be obtained by contacting FFF Enterprises at 1-800-843-7477 or ASD Healthcare at 1-800-746-6273

Dosage And Indications
For post-exposure varicella (chickenpox) infection prophylaxis.
NOTE: Varicella-zoster immune globulin has an orphan drug status for the passive immunization of exposed, susceptible individuals who are at risk of complications from varicella.
Intramuscular dosage Adults

625 International Units/dose (5 vials) IM for adults weighing more than 40 kg. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.[52697] [55354]

Children and Adolescent weighing 40.1 kg and more

625 International Units/dose (5 vials) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Children and Adolescents weighing 30.1 to 40 kg

500 International Units/dose (4 vials) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Children and Adolescents weighing 20.1 to 30 kg

375 International Units/dose (3 vials) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Infants and Children weighing 10.1 to 20 kg

250 International Units/dose (2 vials) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Neonates, Infants, and Children weighing 2.1 to 10 kg

125 International Units/dose (1 vial) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Neonates and Infants weighing 2 kg and less

62.5 International Units/dose (one-half vial) IM. Administer as soon as possible (preferably within 96 hours), but up to 10 days after exposure. Consider a second dose if additional varicella exposures occur more than 3 weeks after initial administration.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Efficacy of live attenuated virus vaccines such as measles/mumps/rubella Vaccines, MMR; rotavirus vaccine; and varicella virus vaccine live may be impaired by varicella-zoster immune globulin administration; revaccination may be necessary. As the passive transfer of antibodies may impair the efficacy of live attenuated virus vaccines, defer vaccination with live virus vaccines until approximately 3 months after varicella-zoster immune globulin administration. Inform the immunizing physician of recent therapy with varicella-zoster immune globulin, so that appropriate measures can be taken.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Efficacy of live attenuated virus vaccines such as measles/mumps/rubella Vaccines, MMR; rotavirus vaccine; and varicella virus vaccine live may be impaired by varicella-zoster immune globulin administration; revaccination may be necessary. As the passive transfer of antibodies may impair the efficacy of live attenuated virus vaccines, defer vaccination with live virus vaccines until approximately 3 months after varicella-zoster immune globulin administration. Inform the immunizing physician of recent therapy with varicella-zoster immune globulin, so that appropriate measures can be taken.
Rotavirus Vaccine: (Major) Defer vaccination with live virus vaccines until approximately 3 months after Varicella Zoster immune globulin administration. Inform the immunizing physician of recent therapy with varicella-zoster immune globulin, so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines such as Rotavirus Vaccine may be impaired by Varicella Zoster immune globulin administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines.

How Supplied

Varicella Zoster Immune Globulin (Human)/VARIZIG Intramuscular Inj Sol: 125IU
VARIZIG Powder Intramuscular Inj Pwd F/Sol: 125IU

Maximum Dosage
Adults

625 International units/dose IM.

Geriatric

625 International units/dose IM.

Adolescents

40.1 kg and more: 625 International units/dose IM.
30.1 to 40 kg: 500 International units/dose IM.
20.1 to 30 kg: 375 International units/dose IM.

Children

40.1 kg and more: 625 International units/dose IM.
30.1 to 40 kg: 500 International units/dose IM.
20.1 to 30 kg: 375 International units/dose IM.
10.1 to 20 kg: 250 International units/dose IM.
2.1 to 10 kg: 125 International units/dose IM.

Infants

10.1 to 20 kg: 250 International units/dose IM.
2.1 to 10 kg: 125 International units/dose IM.

Neonates

2.1 to 10 kg: 125 International units/dose IM.
2 kg and less: 62.5 International units/dose IM.

Mechanism Of Action

Varicella-zoster immune globulin is a preparation of purified human immune globulin G (IgG) containing antibodies to varicella-zoster virus (anti-VZV) and, thus, provides passive immunization for non-immune individuals exposed to the varicella-zoster virus. The product may reduce the severity of varicella infections. No convincing evidence exists that the product reduces the incidence of chickenpox infection after exposure to the virus or that established varicella infections can be modified with the product. Of note, varicella-zoster immune globulin might extend the incubation period of the virus from 10 to 21 days to 28 days or more.

Pharmacokinetics

Varicella-zoster immune globulin is administered via intramuscular (IM) injection. Antibody protection against the varicella zoster virus generally lasts for 3 weeks after product administration in both children and adults. The exact fate of human immunoglobulin products is not well defined, but the mean serum half-life is 26.2 +/- 4.6 days after receipt of 12.5 International units/kg IM.[52697]

Intramuscular Route

The mean peak of varicella antibodies occurred 4.5 +/- 2.8 days after receipt of 12.5 International units/kg IM. Administer varicella-zoster immune globulin as soon as possible after varicella zoster virus exposure.

Pregnancy And Lactation
Pregnancy

Varicella-zoster immune globulin is indicated for post-exposure prophylaxis in high-risk patients such as pregnant women. The manufacturer recommends use during pregnancy only when clearly needed; FDA pregnancy category C drug. According to the recommendations of the Advisory Committee on Immunization Practices, strongly consider varicella zoster immune globulin for pregnant women without evidence of immunity who have been exposed because pregnant women might be at higher risk for severe varicella and complications. Administration of varicella-zoster immune globulin to these women has not been found to prevent viremia, fetal infection, congenital varicella syndrome, or neonatal varicella. Thus, the primary indication for varicella-zoster immune globulin in pregnant women is to prevent complications of varicella in the mother rather than to protect the fetus.

No data are available from the manufacturer regarding the use of varicella-zoster immune globulin during breast-feeding; excretion into breast milk is unknown.[52697] Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[48199]