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Varivax

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Varivax

WARNINGS

No information provided.

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 (varicella virus vaccine live) is unknown.

It is not known whether VARIVAX (varicella virus vaccine live) 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).24

Following administration of VARIVAX (varicella virus vaccine live) , any immune globulin, including VZIG, should not be given for 2 months thereafter unless its use outweighs the benefits of vaccination.24

Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) 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 (varicella virus vaccine live) .

The health care provider should question the patient, parent, or guardian about reactions to a previous dose of VARIVAX (varicella virus vaccine live) or a similar product.

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

VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) . It is also not known whether VARIVAX (varicella virus vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) . Patients and healthcare providers are encouraged to report any exposure to VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) is administered to a nursing woman.

Geriatric Use

Clinical studies of VARIVAX (varicella virus vaccine live) 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 (varicella virus vaccine live) in children less than one year of age and administration to infants under twelve months of age is not recommended.

REFERENCE

24. Recommendations of the Advisory Committee on Immunization Practices (ACIP); General Recommendations on Immunization, MMWR 43(No. RR-1): 15-18, Jan. 28, 1994.

Last reviewed on RxList: 10/16/2008
This monograph has been modified to include the generic and brand name in many instances.

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