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Varivax

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Varivax

Indications
Dosage
How Supplied

INDICATIONS

VARIVAX (varicella virus vaccine live) is indicated for vaccination against varicella in individuals 12 months of age and older.

The duration of protection of VARIVAX (varicella virus vaccine live) is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination.26 In addition, a boost in antibody levels has been observed in vaccinees following exposure to natural varicella as well as following a second dose of VARIVAX (varicella virus vaccine live) .5

In a highly vaccinated population, immunity for some individuals may wane due to lack of exposure to natural varicella as a result of shifting epidemiology. Post-marketing surveillance studies are ongoing to evaluate the need and timing for booster vaccination.

Vaccination with VARIVAX (varicella virus vaccine live) may not result in protection of all healthy, susceptible children, adolescents, and adults (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

FOR SUBCUTANEOUS ADMINISTRATION

Do not inject intravascularly

Children

Children 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously. If a second 0.5-mL dose is administered, it should be given a minimum of 3 months later.

Adolescents and Adults

Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered subcutaneously at elected date and a second 0.5-mL dose 4 to 8 weeks later.

VARIVAX (varicella virus vaccine live) is for subcutaneous administration. The outer aspect of the upper arm (deltoid) is the preferred site of injection.

VARIVAX (varicella virus vaccine live) SHOULD BE STORED FROZEN at an average temperature of -15°C (+5°F) or colder until it is reconstituted for injection (see HOW SUPPLIED, Storage). Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C and has a separate sealed freezer door is acceptable for storing VARIVAX (varicella virus vaccine live) . The diluent should be stored separately at room temperature or in the refrigerator. To reconstitute the vaccine, first withdraw 0.7 mL of diluent into a syringe. Inject all the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume (about 0.5 mL) of reconstituted vaccine subcutaneously, preferably into the outer aspect of the upper arm (deltoid) or the anterolateral thigh. IT IS RECOMMENDED THAT THE VACCINE BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30 MINUTES.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of VARIVAX (varicella virus vaccine live) because these substances may inactivate the vaccine virus.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

To reconstitute the vaccine, use only the Merck sterile diluent supplied with VARIVAX (varicella virus vaccine live) , M-M-R II, or the component vaccines of M-M-R II, since it is free of preservatives or other anti-viral substances which might inactivate the vaccine virus.

Do not freeze reconstituted vaccine.

Do not give immune globulin, including Varicella Zoster Immune Globulin, concurrently with VARIVAX (see also PRECAUTIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VARIVAX (varicella virus vaccine live) when reconstituted is a clear, colorless to pale yellow liquid.

HOW SUPPLIED

No. 4826/4309 — VARIVAX (varicella virus vaccine live) is supplied as follows: (1) a single-dose vial of lyophilized vaccine, NDC 0006-4826-00 (package A); and (2) a box of 10 vials of diluent (package B).

No. 4827/4309 — VARIVAX (varicella virus vaccine live) is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4827-00; and (2) a box of 10 vials of diluent (package B).

Stability

VARIVAX (varicella virus vaccine live) retains a potency level of 1500 PFU or higher per dose for at least 24 months in a frost-free freezer with an average temperature of -15°C (+5°F) or colder.

VARIVAX (varicella virus vaccine live) has a minimum potency level of approximately 1350 PFU 30 minutes after reconstitution at room temperature (20-25°C, 68-77°F).

Prior to reconstitution, VARIVAX (varicella virus vaccine live) retains potency when stored for up to 72 continuous hours at refrigerator temperature (2-8°C, 36-46°F).

For information regarding stability under conditions other than those recommended, call

1-800-9-VARIVAX (varicella virus vaccine live) .

Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of -15°C (+5°F) or colder.

Before reconstitution, store the lyophilized vaccine in a freezer at an average temperature of -15°C (+5°F) or colder. Any freezer (e.g., chest, frost-free) that reliably maintains an average temperature of -15°C and has a separate sealed freezer door is acceptable for storing VARIVAX (varicella virus vaccine live) .

VARIVAX (varicella virus vaccine live) may be stored at refrigerator temperature (2-8°C, 36-46°F) for up to 72 continuous hours prior to reconstitution. Vaccine stored at 2-8°C which is not used within 72 hours of removal from -15°C storage should be discarded.

Before reconstitution, protect from light.

The diluent should be stored separately at room temperature (20-25°C, 68-77°F), or in the refrigerator.

REFERENCES

5. Unpublished data; files of Merck Research Laboratories.

Dist. by: MERCK & CO., INC., Whitehause Station, NJ 08889, USA. Issued March 2008. FDA rev date: n/a

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

Indications
Dosage
How Supplied
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