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Meruvax

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Meruvax

Indications
Dosage
How Supplied

INDICATIONS

Recommended Vaccination Schedule

MERUVAX (rubella virus vaccine live) II is indicated for vaccination against rubella in persons 12 months of age or older.

It is not recommended for infants younger than 12 months because they may retain maternal rubella neutralizing antibodies that may interfere with the immune response.

Children in kindergarten and the first grades of elementary school deserve priority for vaccination because often they are epidemiologically the major source of virus dissemination in the community. A history of rubella illness is usually not reliable enough to exclude children from immunization.

Previously unimmunized children of susceptible pregnant women should receive live attenuated rubella vaccine, because an immunized child will be less likely to acquire natural rubella and introduce the virus into the household.

Individuals first vaccinated with MERUVAX (rubella virus vaccine live) II at 12 months of age or older should be revaccinated with M-M-R* II (Measles, Mumps, and Rubella Virus Vaccine Live) prior to elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of M-M-R II at 12-15 months of age and administration of the second dose of M-M-R II at 4-6 years of age.39 In addition, some public health jurisdictions mandate the age for revaccination. Consult the complete text of applicable guidelines regarding routine revaccination including that of high-risk adult populations.

Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian.

Other Vaccination Considerations

Adolescent and Adult Males

Vaccination of adolescent or adult males may be a useful procedure in preventing or controlling outbreaks of rubella in circumscribed population groups (e.g., military bases and schools).

Non-Pregnant Adolescent and Adult Females

Immunization of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see below and PRECAUTIONS).

Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the fetus and consequent congenital rubella injury.22

Women of childbearing age should be advised not to become pregnant for 3 months after vaccination and should be informed of the reason for this precaution.

The ACIP has stated "If it is practical and if reliable laboratory services are available, women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, with the exception of premarital and prenatal screening, routinely performing serologic tests for all women of childbearing age to determine susceptibility (so that vaccine is given only to proven susceptible women) can be effective but is expensive. Also, 2 visits to the health-care provider would be necessary — one for screening and one for vaccination. Accordingly, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing — and may be preferable, particularly when costs of serology are high and follow-up of identified susceptible women for vaccination is not assured."22

Postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination (see ADVERSE REACTIONS).

Other Populations

Previously unvaccinated children in contact with susceptible pregnant women should receive live attenuated rubella vaccine (such as that contained in MERUVAX (rubella virus vaccine live) II) to reduce the risk of exposure of the pregnant woman.

Individuals planning travel outside the United States, if not immune, can acquire measles, mumps or rubella and import these diseases into the United States. Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can receive either a monovalent vaccine (measles, mumps or rubella), or a combination vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travelers should receive M-M-R II regardless of their immune status to mumps or rubella.23-25

Vaccination is recommended for susceptible individuals in high-risk groups such as college students, health-care workers, and military personnel.22,26

Postpartum Women

It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period (see PRECAUTIONS, Nursing Mothers).

Post-Exposure Vaccination

There is no conclusive evidence that vaccination of individuals recently exposed to natural rubella will provide protection.22,26 There is, however, no contraindication to vaccinating children already exposed to natural rubella.

Use With Other Vaccines

See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.

DOSAGE AND ADMINISTRATION

FOR SUBCUTANEOUS ADMINISTRATION

Do not inject intravenously

The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm. The recommended age for primary vaccination is 12 to 15 months. Revaccination with M-M-R II is recommended prior to elementary school entry. See also INDICATIONS AND USAGE, Recommended Vaccination Schedule.

Immune Globulin (IG) is not to be given concurrently with MERUVAX (rubella virus vaccine live) II.

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 5/8" needle is recommended.

To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine.

Single Dose Vial - First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. MERUVAX (rubella virus vaccine live) II, when reconstituted, is clear yellow.

Use With Other Vaccines

MERUVAX (rubella virus vaccine live) II should not be given less than one month before or after administration of other live viral vaccines.

M-M-R II has been administered concurrently with VARIVAX* [Varicella Virus Vaccine Live (Oka/Merck)], and PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate sites and syringes. No impairment of immune response to individual tested vaccine antigens was demonstrated. The type, frequency, and severity of adverse experiences observed in these studies with M-M-R II were similar to those seen when each vaccine was given alone.

Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.

However, other schedules have been used. The ACIP has stated "Although data are limited concerning the simultaneous administration of the entire recommended vaccine series (i.e., DTP, OPV, MMR, and Hib vaccines, with or without hepatitis B vaccine), data from numerous studies have indicated no interference between routinely recommended childhood vaccines (either live, attenuated, or killed). These findings support the simultaneous use of all vaccines as recommended."21

HOW SUPPLIED

No. 4673/4309 MERUVAX (rubella virus vaccine live) II is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A) NDC 0006-4673-00; and (2) a box of 10 vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature.

Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 10°C (50°F) or colder. Freezing during shipment will not affect potency.

Protect the vaccine from light at all times, since such exposure may inactivate the virus.

Before reconstitution, store the vial of lyophilized vaccine at 2-8°C (36-46°F) or colder. The diluent may be stored in the refrigerator with the lyophilized vaccine or separately at room temperature.

It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in a dark place at 2-8°C (36-46°F) and discard if not used within 8 hours.

REFERENCE

21. Centers for Disease Control and Prevention. Recommended childhood immunization schedule — United States, January-June 1996, MMWR 44(51 & 52): 940-943, January 5, 1996.

22. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MMWR 39(RR-15): 1-18, November 23, 1990.

23. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22, December 29, 1989.

24. Jong, E.G.: The Travel and Tropical Medicine Manual, W.B. Saunders Company, p. 12-16, 1987.

25. Committee on Immunization Council of Medical Societies, American College of Physicians, Phila., PA, Guide for Adult Immunization, First Edition, 1985.

26. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR 43(RR-1): 1-38, January 28, 1994.

39. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 47(RR-8): May 22, 1998.

Manuf. and Dist. by: Merck and Co., INC, Whitehouse station, NJ 08889, USA. FDA Rev date: Jan 2007

Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
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