Varivax: Varicella (chickenpox) Virus Vaccine Live: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VARIVAX safely and effectively. See full prescribing information for VARIVAX.

See full insert sheet at this link at the Natural News Reference website.

VARIVAX® Varicella Virus Vaccine Live

Suspension for subcutaneous injection

Initial U.S. Approval: 1995

INGREDIENTS AND EXCIPIENTS

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.

INDICATIONS AND USAGE

VARIVAX is a vaccine indicated for active immunization for the prevention of varicella in individuals 12 months of age and older. (1)

DOSAGE AND ADMINISTRATION

Each dose is approximately 0.5 mL after reconstitution and is administered by subcutaneous injection. (2.1) 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. (2.1) Adolescents (≥13 years of age) and Adults
• Two doses, to be administered a minimum of 4 weeks apart. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for injection (approximately 0.5-mL dose) supplied as a lyophilized vaccine to be reconstituted using the accompanying sterile diluent. (2.2, 3, 16)

CONTRAINDICATIONS

– History of severe allergic reaction to any component of the vaccine (including neomycin and gelatin) or to a previous dose of varicella vaccine. (4.1)

– Primary or acquired immunodeficiency states. (4.2)

– Any febrile illness or active infection, including untreated tuberculosis. (4.3)

– Pregnancy. (4.4, 8.1, 17)

WARNINGS AND PRECAUTIONS

Evaluate individuals for immune competence prior to administration of VARIVAX if there is a family history of congenital or hereditary immunodeficiency. (5.2)

Avoid contact with high-risk individuals susceptible to varicella because of possible transmission of varicella vaccine virus. (5.4)

Defer vaccination for at least 5 months following blood or plasma transfusions, or administration of immune globulins (IG). (5.5, 7.2)

Avoid use of salicylates for 6 weeks following administration of VARIVAX to children and adolescents. (5.6, 7.1)

ADVERSE REACTIONS

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% (6.1)

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% (6.1)

Other reported adverse reactions in all age groups include:

– varicella-like rash (injection site)

– varicella-like rash (generalized) (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Reye syndrome has been reported in children and adolescents following the use of salicylates during wild-type varicella infection. (5.6, 7.1)

Passively acquired antibodies from blood, plasma, or immunoglobulin potentially may inhibit the response to varicella vaccination. (5.5, 7.2)

Tuberculin skin testing may be performed before VARIVAX is administered or on the same day, or six weeks following vaccination with VARIVAX. (7.3)

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

VARIVAX 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 [see Contraindications (4.4) and Patient Counseling Information (17)]. 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

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.

Human Data

A pregnancy exposure registry was maintained from 1995 to 2013 to monitor pregnancy and fetal outcomes following inadvertent administration of VARIVAX. The registry prospectively enrolled 1522 women who received a dose of VARIVAX during pregnancy or within three months prior to conception. After excluding elective terminations (n=60), ectopic pregnancies (n=1) and those lost to follow-up (n=556), there were 905 pregnancies with known outcomes. Of these 905 pregnancies, 271 (30%) were in women who were vaccinated within the three months prior to conception. Miscarriage was reported for 10% of pregnancies (95/905), and major birth defects were reported for 2.6% of live born infants (21/819). These rates of assessed outcomes were consistent with estimated background rates. None of the women who received VARIVAX vaccine delivered infants with abnormalities consistent with congenital varicella syndrome.

Lactation

Risk Summary

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 VARIVAX, and any potential adverse effects on the breastfed child from VARIVAX or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

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.

Pregnancy: Do not administer VARIVAX to females who are pregnant. Pregnancy should be avoided for 3 months following vaccination with VARIVAX. (4.4, 8.1, 17)

Revised: 02/2017

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM165647.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Varivax-Varicella-(chickenpox)-Virus-Vaccine.pdf