Varivax Special Precautions

General: Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactoid reaction occur.
The duration of protection from varicella infection after vaccination with refrigerator-stable VARIVAX is unknown.
It is not known whether refrigerator-stable VARIVAX given immediately after exposure to wild-type varicella virus will prevent illness.
Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin or varicella zoster immune globulin (VZIG).
Following administration of refrigerator-stable VARIVAX, any immune globulin including VZIG should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination.
Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with refrigerator-stable VARIVAX as Reye syndrome has been reported following the use of salicylates during wild-type varicella infection (see PHARMACOLOGY: Reye Syndrome under Actions).
The safety and efficacy of refrigerator-stable VARIVAX have not been established in children and young adults who are known to be infected with human immunodeficiency viruses with and without evidence of immunosuppression (see also CONTRAINDICATIONS).
Care is to be taken by the health care provider for safe and effective use of refrigerator-stable VARIVAX.
The health care provider should question the patient, parent, or guardian about reactions to a previous dose of refrigerator-stable VARIVAX or a similar product.
The health care provider should obtain the previous immunization history of the vaccinee.
Refrigerator-stable VARIVAX should not be injected into a blood vessel.
Vaccination should be deferred in patients with a family history of congenital or hereditary immunodeficiency until the patient's own immune system has been evaluated.
A separate sterile needle and syringe should be used for administration of each dose of refrigerator-stable VARIVAX to prevent transfer of infectious diseases.
Needles should be disposed of properly and should not be recapped.
Transmission: Post-marketing experience suggests that transmission of varicella vaccine virus (Oka/Merck) resulting in varicella infection including disseminated disease may occur rarely between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy as well as high-risk individuals.
Therefore, vaccine recipients should attempt to avoid, whenever possible, close association with susceptible high-risk individuals for up to six weeks. In circumstances where contact with high-risk individuals is unavoidable, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus. Susceptible high-risk individuals include: immunocompromised individuals; pregnant women without documented history of chickenpox or laboratory evidence of prior infection; newborn infants of mothers without documented history of chickenpox or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.
Drug Interactions: See General as previously mentioned, regarding the administration of immune globulins, salicylates, and transfusions.
Drug Interactions, Use with Other Vaccines: Results from clinical studies indicate that refrigerator-stable VARIVAX can be administered concomitantly with M-M-R II, diphtheria and tetanus toxoids and pertussis vaccine adsorbed and Haemophilus influenzae type b conjugate combined vaccine, or Haemophilus influenzae type b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combined vaccine (see PHARMACOLOGY: Studies with Other Vaccines under Actions).
Limited data from an experimental product containing varicella vaccine suggest that refrigerator-stable VARIVAX can be administered concomitantly with DTaP and PedvaxHIB using separate sites and syringes (see PHARMACOLOGY: Studies with Other Vaccines under Actions). However, there are no data relating to simultaneous administration of refrigerator-stable VARIVAX with DTP or OPV.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Refrigerator-stable VARIVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Use in Pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with refrigerator-stable VARIVAX. It is also not known whether refrigerator-stable VARIVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, refrigerator-stable VARIVAX should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).
Use in Lactation: It is not known whether varicella vaccine virus is secreted in human milk. Therefore, because some viruses are secreted in human milk, caution should be exercised if refrigerator-stable VARIVAX is administered to a nursing woman. (See Transmission as previously mentioned.)
Use in Children: No clinical data are available on safety or efficacy of refrigerator-stable VARIVAX in children less than one year of age, and administration to infants under twelve months of age is not recommended.
Use in the Elderly: 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. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.