Clinical Information
Gen. Code and Des.
60760 varicella vaccine live/PF SUBCUT VIAL 1350 UNIT
GCN and Des.
26999 varicella vaccine live/PF SUBCUT VIAL 1350 UNIT
Strength
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80120000 VACCINES
Active Ingredients
3023 varicella virus vaccine live
9870 preservative free
Inactive Ingredients
2549 gelatin 9000708
2598 sucrose 57501
3785 edetic acid 60004
9283 beef derived (bovine)
Varivax� Chicken Pox Vaccine Varicella Virus Vaccine Live, Preservative Free 1350 PFU Injection Single Dose Vial 0.5 mL
VARIVAX- varicella-zoster virus strain oka/merck live antigen injection, powder, lyophilized, for suspension
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
VARIVAX� is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
Subcutaneous administration only
2.1 Recommended Dose and Schedule
VARIVAX is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh.
Do not administer this product intravascularly or intramuscularly.
Children (12 months to 12 years of age)
If a second dose is administered, there should be a minimum interval of 3 months between doses [see Clinical Studies (14.1)].
Adolescents (≥13 years of age) and Adults
Two doses of vaccine, to be administered with a minimum interval of 4 weeks between doses [see Clinical Studies (14.1)].
2.2 Reconstitution Instructions
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.
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.
To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine subcutaneously. VARIVAX, when reconstituted, is a clear, colorless to pale yellow liquid.
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.
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.
3 DOSAGE FORMS AND STRENGTHS
VARIVAX is a suspension for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16)]. A single dose after reconstitution is approximately 0.5 mL.
4 CONTRAINDICATIONS
4.1 Severe Allergic Reaction
Do not administer VARIVAX 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.
4.2 Immunosuppression
Do not administer VARIVAX to immunosuppressed or immunodeficient individuals, including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS, or other clinical manifestations of infection with human immunodeficiency virus (HIV).
Do not administer VARIVAX to individuals receiving immunosuppressive therapy, including individuals receiving immunosuppressive doses of corticosteroids.
VARIVAX is a live, attenuated varicella-zoster vaccine (VZV) and may cause an extensive vaccine-associated rash or disseminated disease in individuals who are immunosuppressed or immunodeficient.
4.3 Concurrent Illness
Do not administer VARIVAX to individuals with any febrile illness. Do not administer VARIVAX to individuals with active, untreated tuberculosis.
4.4 Pregnancy
Do not administer VARIVAX to individuals who are pregnant because the effects of the vaccine on fetal development are unknown. Wild-type varicella (natural infection) is known to sometimes cause fetal harm. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination [see Use in Specific Populations (8.1) and Patient Counseling Information (17)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should anaphylaxis occur.
5.2 Family History of Immunodeficiency
Vaccination should be deferred in patients with a family history of congenital or hereditary immunodeficiency until the patient's immune status has been evaluated and the patient has been found to be immunocompetent.
5.3 Use in HIV-Infected Individuals
The Advisory Committee for Immunization Practices (ACIP) has recommendations on the use of varicella vaccine in HIV-infected individuals.
5.4 Risk of Vaccine Virus Transmission
Post-marketing experience suggests that transmission of vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from a mother who did not develop a varicella-like rash to her newborn infant has been reported.
Due to the concern for transmission of vaccine virus, vaccine recipients should attempt to avoid whenever possible close association with susceptible high-risk individuals for up to six weeks following vaccination with VARIVAX. Susceptible high-risk individuals include:
Immunocompromised individuals;
Pregnant women without documented history of varicella or laboratory evidence of prior infection;
Newborn infants of mothers without documented history of varicella or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.
5.5 Immune Globulins and Transfusions
Immunoglobulins should not be given concomitantly with VARIVAX. Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin(s) {1}.
Following administration of VARIVAX, immune globulin(s) should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination {1}. [See Drug Interactions (7.2).]
5.6 Salicylate Therapy
Avoid use of salicylates (aspirin) or salicylate-containing products in children and adolescents 12 months through 17 years of age for six weeks following vaccination with VARIVAX because of the association of Reye syndrome with aspirin therapy and wild-type varicella infection. [See Drug Interactions (7.1).]
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice. Vaccine-related adverse reactions reported during clinical trials were assessed by the study investigators to be possibly, probably, or definitely vaccine-related and are summarized below.
In clinical trials {2-9}, VARIVAX was administered to over 11,000 healthy children, adolescents, and adults.
In a double- blind, placebo- controlled study among 914 healthy children and adolescents who were serologically confirmed to be susceptible to varicella, the only adverse reactions that occurred at a significantly (p<0.05) greater rate in vaccine recipients than in placebo recipients were pain and redness at the injection site {2}.
Children 1 to 12 Years of Age
One-Dose Regimen in Children
DESCRIPTION
VARIVAX [Varicella Virus Vaccine Live] is a preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at Merck Research Laboratories (MRL) in human diploid cell cultures (MRC-5) that were free of adventitious agents. This live, attenuated varicella vaccine is a lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.
VARIVAX, when reconstituted as directed, is a sterile preparation for subcutaneous injection. Each approximately 0.5-mL dose contains a minimum of 1350 plaque-forming units (PFU) of Oka/Merck varicella virus when reconstituted and stored at room temperature for a maximum of 30 minutes. Each 0.5-mL dose also contains approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg of sodium chloride, 0.5 mg of monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, and 0.08 mg of potassium chloride. The product also contains residual components of MRC-5 cells including DNA and protein and trace quantities of sodium phosphate monobasic, EDTA, neomycin and fetal bovine serum. The product contains no preservative.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
VARIVAX 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
