Varivax SC Injection

This is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.

Varicella Virus Vaccine induces both cell-mediated and humoral immune responses to varicella-zoster virus. The relative contributions of humoral immunity and cell-mediated immunity to protection from varicella are unknown.

Each 0.5 mL dose of Varicella Virus Vaccine is administered subcutaneously. Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

Children (12 months to 12 years of age): The first dose is administered at 12 to 15 months of age but may be given anytime through 12 years of age. The second dose is administered at 4 to 6 years of age. At least 3 months should elapse between a dose of varicella-containing vaccine. At least 1 month should elapse between a dose of measles-containing vaccine and a dose of Varicella Virus Vaccine if the vaccines are not given concurrently.

Adolescents (≥13 years of age) and Adults: Two doses of Varicella Virus Vaccine are administered at a minimum interval of 4 weeks.

Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. Administration of immune globulins and other blood products concurrently with Varivax vaccine may interfere with the expected immune response. Varivax vaccination may result in a temporary depression of purified protein derivative (PPD) tuberculin skin sensitivity.

Severe Allergic Reaction: Do not administer Varicella Virus Vaccine to individuals with a history of anaphylactic or severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of a varicella-containing vaccine.

Immunosuppression: Do not administer Varicella Virus Vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Disseminated varicella disease and extensive vaccine associated rash have been reported in individuals who are immunosuppressed or immunodeficient who were inadvertently vaccinated with a varicella-containing vaccine.

Moderate or Severe Febrile Illness: Do not administer Varicella Virus Vaccine to individuals with an active febrile illness with fever >38.5°C.

Active Untreated Tuberculosis: Do not administer Varicella Virus Vaccine to individuals with active, untreated tuberculosis (TB).

Pregnancy: Do not administer Varicella Virus Vaccine to individuals who are pregnant or planning on becoming pregnant in the next 3 months. Wild-type varicella is known to cause fetal harm.

Frequently reported (≥10%) adverse reactions in children ages 1 to 12 years include:

• fever ≥102.0°F (38.9°C) oral: 14.7%
• injection-site complaints: 19.3%

Frequently reported (≥10%) adverse reactions in adolescents and adults ages 13 years and older include:

• fever ≥100.0°F (37.8°C) oral: 10.2%
• injection-site complaints: 24.4%

Other reported adverse reactions in all age groups include:

• varicella-like rash (injection site)
• varicella-like rash (generalized)

Varicella Virus Vaccine is contraindicated for use in pregnant women because the vaccine contains live, attenuated varicella virus, and it is known that wild-type varicella virus, if acquired during pregnancy, can cause congenital varicella syndrome. No increased risk for miscarriage, major birth defect or congenital varicella syndrome was observed in a pregnancy exposure registry that monitored outcomes after inadvertent use. There are no relevant animal data.

It is not known whether varicella vaccine virus is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Varicella Virus Vaccine, and any potential adverse effects on the breastfed child from Varicella Virus Vaccine or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Evaluate individuals for immune competence prior to administration of Varivax if there is a family history of congenital or hereditary immunodeficiency. Avoid close contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. Immune Globulins (IG) and other blood products should not be given concomitantly with Varivax. Avoid use of salicylates for 6 weeks following administration of Varivax to children and adolescents.

Pediatric Use: No clinical data are available on safety or efficacy of Varivax in children less than 12 months of age.

Geriatric Use: Clinical studies of Varivax did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.

Vaccines, Anti-sera & Immunoglobulin

Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of Varivax because these substances may inactivate the vaccine virus. When reconstituting the vaccine, use only the sterile diluent supplied with Varivax. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus. To reconstitute the vaccine, withdraw the total volume of supplied sterile diluent and inject into the lyophilized vaccine vial. Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white compact crystalline plug. Varivax, when reconstituted, is a clear, colorless to pale yellow liquid. Withdraw the entire amount of reconstituted vaccine, inject the total volume and discard vial. To minimize loss of potency, administer Varivax immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes. Do not freeze reconstituted vaccine. Do not combine Varivax with any other vaccine through reconstitution or mixing.

Store between 2-8° C. Do not freeze. Protect from light. Keep out of the reach of children.