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Varivax (Varicella Virus Vaccine Live) - Warnings and Precautions

 
 



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 VARIVAX is unknown.

It is not known whether VARIVAX given immediately after exposure to natural 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 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 VARIVAX as Reye's Syndrome has been reported following the use of salicylates during natural varicella infection (see CLINICAL PHARMACOLOGY, Reye's Syndrome).

The safety and efficacy of 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 VARIVAX.

The health care provider should question the patient, parent, or guardian about reactions to a previous dose of VARIVAX or a similar product.

The health care provider should obtain the previous immunization history of the vaccinee.

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 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 vaccine virus may occur rarely between healthy vaccinees who develop a varicella-like rash and healthy susceptible contacts. Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported but has not been confirmed.

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 natural 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

INFORMATION FOR PATIENTS

The health care provider should inform the patient, parent or guardian of the benefits and risks of VARIVAX.

Patients, parents, or guardians should be instructed to report any adverse reactions to the health care provider.

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, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The VAERS toll-free number for VAERS forms and information is 1-800-822-7967.

Pregnancy should be avoided for three months following vaccination.

DRUG INTERACTIONS

See PRECAUTIONS, General, regarding the administration of immune globulins, salicylates, and transfusions.

DRUG INTERACTIONS, USE WITH OTHER VACCINES

Results from clinical studies indicate that VARIVAX can be administered concomitantly with M-M-R II, COMVAX, or TETRAMUNE (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines).

Limited data from an experimental product containing varicella vaccine suggest that VARIVAX can be administered concomitantly with DTaP and PedvaxHIB using separate sites and syringes (see CLINICAL PHARMACOLOGY, Studies with Other Vaccines). However, there are no data relating to simultaneous administration of VARIVAX with DTP or OPV.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

VARIVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.

PREGNANCY

Pregnancy Category C: Animal reproduction studies have not been conducted with VARIVAX. It is also not known whether VARIVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, VARIVAX should not be administered to pregnant females; furthermore, pregnancy should be avoided for three months following vaccination (see CONTRAINDICATIONS).

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to VARIVAX. Patients and healthcare providers are encouraged to report any exposure to VARIVAX during pregnancy by calling (800) 986-8999.

NURSING MOTHERS

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 VARIVAX is administered to a nursing woman.

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. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.

PEDIATRIC USE

No clinical data are available on safety or efficacy of VARIVAX in children less than one year of age, and administration to infants under twelve months of age is not recommended.

Page last updated: 2006-08-16

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