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Varicella-zoster immune globulin (human): Pediatric drug information

Varicella-zoster immune globulin (human): Pediatric drug information
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Brand Names: US
  • Varizig
Brand Names: Canada
  • VariZIG
Therapeutic Category
  • Immune Globulin
Dosing: Neonatal
Postexposure prophylaxis, varicella

Postexposure prophylaxis, varicella: Note: Administration should begin as soon as possible (ideally within 96 hours) and within 10 days after exposure (CDC 2013). High-risk, susceptible patients who are reexposed >3 weeks after a prior dose of VZIG should receive another full dose. The minimum dose is 62.5 units.

≤2 kg: IM: 62.5 units

2.1 to 10 kg: IM: 125 units

Dosing: Pediatric

Note: Administration should begin as soon as possible (ideally within 96 hours) and within 10 days after exposure (CDC 2013). In hematopoietic cell transplant (HCT) recipients who are exposed to varicella or zoster or a varicella zoster vaccine vaccinee who develops a varicella-like rash, administration should occur within 96 hours, ideally within 48 hours (Tomblyn, 2009). High-risk, susceptible patients who are reexposed >3 weeks after a prior dose of VZIG may receive another full dose. The minimum dose is 62.5 units and the maximum dose is 625 units. Route of administration may vary based on product availability (eg, shortages), consult product specific labeling in these cases. Dosing based on US product labeling.

Postexposure prophylaxis, varicella

Postexposure prophylaxis, varicella: Infants, Children, and Adolescents: IM:

≤2 kg: 62.5 units

2.1 to 10 kg: 125 units

10.1 to 20 kg: 250 units

20.1 to 30 kg: 375 units

30.1 to 40 kg: 500 units

>40 kg: 625 units

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Varicella-zoster immune globulin (human): Drug information")

Varicella postexposure prophylaxis

Varicella postexposure prophylaxis: IM: ≥40.1 kg: 625 units as a single dose. Dose may be repeated for high-risk patients with additional exposure >3 weeks after initial administration.

Note: Administration should begin as soon as possible (ideally within 96 hours) and within 10 days after exposure (CDC 2013). Administration should begin within 96 hours (ideally 48 hours) in hematopoietic cell transplant recipients who are exposed to varicella, zoster, or a varicella zoster vaccinee who develops a varicella-like rash (ASBMT/IDSA [Tomblyn 2009]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Skin rash (1%, including erythematous rash, pruritus, urticaria, vesicular eruption)

Gastrointestinal: Nausea (1%)

Local: Pain at injection site (3%)

Nervous system: Chills (1%), fatigue (1%), headache (2%)

<1%: Hypersensitivity: Serum sickness

Frequency not defined:

Gastrointestinal: Vomiting

Miscellaneous: Fever

Contraindications

US labeling: History of anaphylaxis or severe systemic (hypersensitivity) reactions to human immune globulins; IgA deficiency with antibodies against IgA and a history of hypersensitivity.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to any component of the formulation; patients with evidence of immunity to varicella zoster virus (ie, with previous varicella infection or vaccination)

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions may occur; discontinue immediately and provide appropriate treatment. Patients with known antibodies to IgA have a greater risk of severe hypersensitivity and anaphylactic reactions.

• Thrombotic events: Thrombotic events have been reported with use of immune globulin products; use with caution in patients with multiple cardiovascular risk factors, history of atherosclerosis, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known hyperviscosity disorders. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with severe thrombocytopenia or any coagulation disorder; IM administration may be contraindicated.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intramuscular [preservative free]:

Varizig: 125 units/1.2 mL (1.2 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (Varizig Intramuscular)

125UNIT/1.2ML (per mL): $2,182.57

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

VariZIG: 125 units/1.2 mL (1.2 mL) [contains polysorbate 80]

Administration: Pediatric

For IM administration only. Bring to room temperature prior to use. Administer into deltoid muscle or anterolateral aspect of upper thigh; avoid gluteal region; divide into 2 or more injections depending on patient size. Do not exceed 3 mL per injection site.

Administration: Adult

IM: For IM administration only. Bring to room temperature prior to administration. Administer into deltoid muscle or anterolateral aspect of upper thigh in ≥2 injections depending on patient size. Avoid gluteal region as a routine injection site (due to risk of sciatic nerve injury); only use the upper, outer quadrant if used. Do not use >3 mL per injection site.

Storage/Stability

Solution for injection: Store at 2°C to 8°C (36°F to 46°F); do not freeze. Discard any unused portion.

Use

Postexposure prophylaxis of varicella in high-risk individuals including: Immunocompromised children and adults; newborns of mothers with varicella shortly before or after delivery; premature infants, neonates, and infants <1 year of age; adults without evidence of immunity; pregnant women (FDA approved in all ages)

The Advisory Committee on Immunization Practices (ACIP) recommends varicella-zoster immune globulin (VZIG) for patients who are at high risk for severe varicella infection and complications, patients who were exposed to varicella or herpes zoster, and patients for whom varicella vaccine is contraindicated. The decision to use VZIG should take into consideration if the patient lacks evidence of immunity, if exposure is likely to result in an infection, and if the patient is at greater risk for varicella complications than the general population. The following are patient groups for whom VZIG is recommended (CDC 2013):

• Immunocompromised patients without evidence of immunity, including those with neoplastic disease (eg, leukemia or lymphoma), primary or acquired immunodeficiency, and immunosuppressive therapy (including steroid therapy equivalent to prednisone ≥2 mg/kg or 20 mg/day)

• Newborn of mother who had onset of chickenpox within 5 days before delivery or within 48 hours after delivery

• Hospitalized premature infants (≥28 weeks gestation) who were exposed during the neonatal period and whose mother has no history of chickenpox

• Hospitalized premature infants (<28 weeks gestation or ≤1,000 g) regardless of maternal history and who were exposed during the neonatal period

• Pregnant women without evidence of immunity who have been exposed

Medication Safety Issues
Sound-alike/look-alike issues:

Varicella virus vaccine has been given in error (instead of the indicated varicella immune globulin) to pregnant women exposed to varicella.

VZIG may be confused with Varivax

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Dinutuximab Beta: Immune Globulins may diminish the therapeutic effect of Dinutuximab Beta. Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification

Pregnancy Considerations

Varicella zoster immune globulin (VZIG) is made of purified human IgG. Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).

Women who do not have evidence of immunity to varicella may be at increased risk of complications if infected during pregnancy. Varicella infection in the mother can also lead to intrauterine infection in the fetus. VZIG is primarily used to prevent maternal complications, not fetal infection (CDC 2007). The safety of varicella immune globulin during pregnancy has been evaluated (Swamy 2019). VZIG is indicated for postexposure prophylaxis of varicella in high-risk patients, including patients who are pregnant (CDC 2013).

Monitoring Parameters

Observe for adverse effects following administration; baseline assessment of blood viscosity in patients at risk for hyperviscosity; signs and symptoms of varicella infection for 28 days after VZIG administration (CDC 2013).

Mechanism of Action

Antibodies obtained from pooled human plasma of individuals with high titers of varicella-zoster provide passive immunity.

Pharmacokinetics (Adult Data Unless Noted)

Duration: ≥6 weeks

Metabolism: Metabolized in the reticuloendothelial system

Bioavailability: 100%

Half-life elimination: IV: 18 to 24 days; IM: 26.2 ± 4.6 days

Time to peak, plasma: IV: <3 hours; IM: 4.5 ± 2.8 days

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Varitect;
  • (AT) Austria: Varitect;
  • (CO) Colombia: Varitect | Varitect cp;
  • (CZ) Czech Republic: Varitect;
  • (DE) Germany: Varicellon | Varitect;
  • (EE) Estonia: Varizig;
  • (GR) Greece: Varitect cp;
  • (HK) Hong Kong: Varitect;
  • (IT) Italy: Varitect;
  • (KR) Korea, Republic of: Gcc human varicella immunoglobulin;
  • (KW) Kuwait: Varizig;
  • (LT) Lithuania: Varitect;
  • (LV) Latvia: Varitect cp;
  • (MY) Malaysia: Varitect;
  • (NL) Netherlands: Variquin;
  • (NO) Norway: Varicellon | Varitect cp | Varizig;
  • (NZ) New Zealand: Zoster Immunoglobulin VF;
  • (PL) Poland: Varitect | Varitect cp;
  • (PR) Puerto Rico: Varicella zoster immunoglobulin;
  • (RU) Russian Federation: Immunoglobulin Herpes;
  • (SA) Saudi Arabia: Varitect | Varitect cp | Varizig;
  • (TH) Thailand: Varitect;
  • (UY) Uruguay: Varitect;
  • (ZA) South Africa: Vazigam
  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Agarwal S, Karmaus W, Davis S, et al, "Immune Markers in Breast Milk and Fetal and Maternal Body Fluids: A Systematic Review of Perinatal Concentrations," J Hum Lact, 2011, 27(2):171-86. [PubMed 21678611]
  3. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.
  4. Centers for Disease Control and Prevention (CDC), "FDA Approval of an Extended Period for Administering VariZIG for Postexposure Prophylaxis of Varicella," MMWR Morb Mortal Wkly Rep, 2012, 61:212. [PubMed 22456121]
  5. Centers for Disease Control, “Prevention of Varicella, Recommendations of the Advisory Committee on Immunization Practices (ACIP),” MMWR Recomm Rep, 2007, 56(RR4);1-40. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm [PubMed 17585291]
  6. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of VariZIG -- United States, 2013. MMWR Morb Mortal Wkly Rep. 2013;62(28):574-576. [PubMed 23863705]
  7. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  8. Cohen A, Moschopoulos P, Stiehm RE, et al, "Congenital Varicella Syndrome: The Evidence for Secondary Prevention With Varicella-Zoster Immune Globulin," CMAJ, 2011, 183(2):204-8. [PubMed 21262937]
  9. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  10. Lamont RF, Sobel JD, Carrington D, et al, "Varicella-Zoster Virus (Chickenpox) Infection in Pregnancy," BJOG, 2011, 118(10):1155-62. [PubMed 21585641]
  11. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  12. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi: 10.1155/2012/985646. [PubMed 22235228]
  13. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi: 10.1002/bdrb.20201. [PubMed 19626656]
  14. Sendelbach DM and Sanchez PJ, "Varicella, Influenza: Not Necessary to Separate Mother and Infant," Pediatrics, 2012, 130(2):e464. 22855925. [PubMed 22855925]
  15. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. [PubMed 7746084]
  16. Swamy GK, Dotters-Katz SK. Safety and varicella outcomes after varicella zoster immune globulin administration in pregnancy. Am J Obstet Gynecol. 2019;221(6):655-656. doi: 10.1016/j.ajog.2019.07.003. [PubMed 31279845]
  17. Tomblyn M, Chiller T, Einsele H et al. Guidelines for preventing infectious complications among hematopoietic cell transplant recipients: a global perspective. Biol Blood Marrow Transplant. 2009;15(10):1143-238. [PubMed 19747629] 10.1016/j.bbmt.2009.06.019
  18. Varizig (varicella zoster immune globulin [human]) solution for injection [prescribing information]. Hoboken, NJ; September 2022.
  19. Varizig (varicella zoster immune globulin [human]) solution for injection [product monograph]. Winnipeg, Manitoba, Canada: Emergent BioSolutions Inc; December 2017.
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