"What is Shingles?
Shingles is a painful skin rash, often with blisters. It is also called Herpes Zoster, or just Zoster.
A shingles rash usually appears on one side of the face or body and lasts from 2 to 4 weeks. Its main sym"...
Management Of Allergic Reactions
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.
Use In HIV-Infected Individuals
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.
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 vaccination1. [See DRUG INTERACTIONS]
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]
Patient Counseling Information
See FDA-Approved Patient Labeling (PATIENT INFORMATION).
Discuss the following with the patient:
- Question the patient, parent, or guardian about reactions to previous vaccines.
- Provide a copy of the patient information (PPI) located at the end of this insert and discuss any questions or concerns.
- Inform patient, parent, or guardian that vaccination with VARIVAX may not result in protection of all healthy, susceptible children, adolescents, and adults.
- Inform female patients to avoid pregnancy for three months following vaccination.
- Inform patient, parent, or guardian of the benefits and risks of VARIVAX.
- Instruct patient, parent, or guardian to report any adverse reactions or any symptoms of concern to their healthcare professional.
The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at http://www.vaers.hhs.gov.
Use In Specific Populations
Contraindication [see CONTRAINDICATIONS]. VARIVAX should not be administered to pregnant females since wild-type varicella can sometimes cause congenital varicella infection. Pregnancy should be avoided for three months following vaccination with VARIVAX [see CONTRAINDICATIONS and PATIENT INFORMATION].
From 1995 to 2013, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., maintained a Pregnancy Registry to monitor fetal outcomes following inadvertent administration of VARIVAX during pregnancy or within three months prior to conception. In 2006, reports of exposure to two other varicella (Oka/Merck)-containing vaccines, ProQuad® (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) and ZOSTAVAX® (Zoster Vaccine Live), were added to the Registry. The Pregnancy Registry has been discontinued. As of March 2011, 811 women with pregnancy outcome information available for analysis were prospectively enrolled following vaccination with VARIVAX, within three months prior to conception or any time during pregnancy. Of these women, 170 were seronegative at the time of exposure and 627 women had an unknown serostatus. The remaining women were seropositive. Nine exposures to either ProQuad or ZOSTAVAX have been reported that met criteria for inclusion into the Registry.
None of the 820 women who received a varicella-containing vaccine delivered infants with abnormalities consistent with congenital varicella syndrome.
All exposures to VARIVAX, ProQuad, or ZOSTAVAX during pregnancy or within three months prior to conception should be reported as suspected adverse reactions by contacting 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.
It is not known whether varicella vaccine virus is excreted in human milk. Therefore, because some viruses are excreted in human milk, caution should be exercised if VARIVAX is administered to a nursing woman. [See WARNINGS AND PRECAUTIONS]
No clinical data are available on safety or efficacy of VARIVAX in children less than 12 months of age.
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.
1. CDC: General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 55(No. RR-15): 1-47, 2006.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/21/2015
Additional Varivax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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