Rubella Virus Vaccine Live (Meruvax)
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Rubella Virus Vaccine Live (Meruvax)

MERUVAX® II
(rubella virus) Vaccine Live

Wistar RA 27/3 Strain

DRUG DESCRIPTION

MERUVAX® II (Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against rubella (German measles).

MERUVAX (rubella virus vaccine live) II is a sterile lyophilized preparation of the Wistar Institute RA 27/3 strain of live attenuated rubella virus. The virus was adapted to and propagated in WI-38 human diploid lung fibroblasts.1,2

The growth medium is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing human serum albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.

The cells, virus pools, fetal bovine serum, and human albumin are all screened for the absence of adventitious agents. Human albumin is processed using the Cohn cold ethanol fractionation procedure.

The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of rubella virus. Each dose of the vaccine is calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), human albumin (0.3 mg), fetal bovine serum ( < 1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin. The product contains no preservative.

Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug. MERUVAX (rubella virus vaccine live) II, when reconstituted as directed, is clear yellow.

What are the possible side effects of rubella virus vaccines (Meruvax II)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

REFERENCES

What are the possible side effects of rubella virus vaccines (Meruvax II)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

1. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studies of immunization with living rubella virus: Trials in children with a strain cultured from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.

What are the possible side effects of rubella virus vaccines (Meruvax II)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

2. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fibroblasts: Evidence for reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.

What are the possible side effects of rubella virus vaccines (Meruvax II)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get...

Read All Potential Side Effects and See Pictures of Meruvax »

What are the precautions when taking rubella virus vaccine live (Meruvax)?

Before receiving rubella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells...

Read All Potential Precautions of Meruvax »

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

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.

SIDE EFFECTS

The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of polyvalent vaccine containing rubella:

Body as a Whole

Fever; syncope; headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Diarrhea; vomiting; nausea.

Hemic and Lymphatic System

Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; regional lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history.

Musculoskeletal System

Arthritis; arthralgia; myalgia.

Chronic arthritis has been associated with natural rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.

Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-26%)7,36,37 and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in women older than 35 years, these reactions are generally well tolerated and rarely interfere with normal activities. Myalgia and paresthesia have been reported rarely after administration of MERUVAX (rubella virus vaccine live) II.

Nervous System

Encephalitis; Guillain-Barré syndrome (GBS); polyneuritis; polyneuropathy; paresthesia.

Respiratory System

Sore throat; cough; rhinitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; pruritis

Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema); pain; induration.

Special Senses — Ear

Nerve deafness; otitis media.

Special Senses — Eye

Optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.

Other

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established. No deaths or permanent sequelae were reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982-1993.38

Under the National Childhood Vaccine Injury Act of 1986, health-care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.31 A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967. 31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

Read the Meruvax (rubella virus vaccine live) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Immunosuppressive Therapy

The immune status of patients about to undergo immunosuppressive therapy should be evaluated so that the physician can consider whether vaccination prior to the initiation of treatment is indicated (see CONTRAINDICATIONS and PRECAUTIONS).

The ACIP has stated that "patients with leukemia in remission who have not received chemotherapy for at least 3 months may receive live-virus vaccines. Short-term ( < 2 weeks), low- to moderate-dose systemic corticosteroid therapy, topical steroid therapy (e.g., nasal, skin), long-term alternate-day treatment with low to moderate doses of short-acting systemic steroid, and intra-articular, bursal, or tendon injection of corticosteroids are not immunosuppressive in their usual doses and do not contraindicate the administration of rubella vaccine."22

Immune Globulin

Administration of immune globulins concurrently with MERUVAX (rubella virus vaccine live) II may interfere with the expected immune response.22,30

See also PRECAUTIONS, General.

REFERENCE

7. Unpublished data from the files of Merck Research Laboratories.

31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

36. Gershon, A.; et al: Live attenuated rubella virus vaccine: comparison of responses to HPV-77-DE5 and RA 27/3 strains, Am. J. Med. Sci. 279(2): 95-97, 1980.

37. Weibel, R.E.; et al: Clinical and laboratory studies of live attenuated RA 27/3 and HPV-77-DE rubella virus vaccines, Proc. Soc. Exp. Biol. Med. 165: 44-49, 1980.

38. Peltola, H.; et al: The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two dose vaccination program. N. Engl. J. Med. 331: 1397-1402, 1994.

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

WARNINGS

The physician should be alert to the temperature elevation which may occur following vaccination (see ADVERSE REACTIONS).

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. Although there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin.

Hypersensitivity to Neomycin

The AAP states, "Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine. Most often, however, neomycin allergy manifests as a contact dermatitis, which is a delayed-type (cell-mediated) immune response rather than anaphylaxis. In such persons, an adverse reaction to neomycin in the vaccine would be an erythematous, pruritic nodule or papule, 48 to 96 hours after vaccination. A history of contact dermatitis to neomycin is not a contraindication to receiving measles vaccine."30

Thrombocytopenia

Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-R II (or its component vaccines) may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases (see ADVERSE REACTIONS).

PRECAUTIONS

General

Adequate treatment provisions including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

Special care should be taken to ensure that the injection does not enter a blood vessel.

Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals. Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk.22 However, transmission of the vaccine virus to infants via breast milk has been documented (see Nursing Mothers).

Children and young adults who are known to be infected with human immunodeficiency viruses and are not immunosuppressed may be vaccinated. However, vaccinees who are infected with HIV should be monitored closely for vaccine-preventable diseases because immunization may be less effective than for uninfected persons (see CONTRAINDICATIONS).28,29

Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).30 However, susceptible postpartum patients who received blood products may receive MERUVAX (rubella virus vaccine live) II prior to discharge provided that a repeat HI titer is drawn 6-8 weeks after vaccination to ensure seroconversion. Similarly, although studies with other live rubella virus vaccines suggest that MERUVAX (rubella virus vaccine live) II may be given in the immediate postpartum period to those nonimmune women who have received anti-Rho (D) globulin (human) without interfering with vaccine effectiveness, a follow-up post-vaccination HI titer should also be determined.

It has been reported that attenuated rubella virus vaccine live may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with MERUVAX (rubella virus vaccine live) II.

Individuals with active untreated tuberculosis should not be vaccinated.

As for any vaccine, vaccination with MERUVAX (rubella virus vaccine live) II may not result in protection in 100% of vaccinees.

The health-care provider should determine the current health status and previous vaccination history of the vaccinee.

The health-care provider should question the patient, parent or guardian about reactions to a previous dose of MERUVAX (rubella virus vaccine live) II or other measles-, mumps-, or rubella-containing vaccines.

Laboratory Tests

See INDICATIONS AND USAGE, Non-Pregnant Adolescents and Adult Females, for Rubella Susceptibility Testing, and CLINICAL PHARMACOLOGY.

Carcinogenesis, Mutagenesis, Impairment of Fertility

MERUVAX (rubella virus vaccine live) II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with MERUVAX (rubella virus vaccine live) II. It is also not known whether MERUVAX (rubella virus vaccine live) II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There is evidence suggesting transmission of rubella vaccine viruses to products of conception.32 Therefore, rubella vaccine should not be administered to pregnant females (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and CONTRAINDICATIONS).

In counseling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware of the following: In a 10-year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception, (of whom 189 received the Wistar RA 27/3 strain) none of the newborns had abnormalities compatible with congenital rubella syndrome.32

Nursing Mothers

Recent studies have shown that lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.33 In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.34,35 Caution should be exercised when MERUVAX (rubella virus vaccine live) II is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in infants below the age of 12 months have not been established (see INDICATIONS AND USAGE, Recommended Vaccination Schedule).

Geriatric Use

Clinical studies of MERUVAX (rubella virus vaccine live) II 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.

REFERENCE

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

28. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.

29. Krasinski, K.; Borkowsky, W.; Krugman, S.: Antibody following measles immunization in children infected with human T-cell lymphotropic virus-type III/lymphadenopathy associated virus (HTLV-III/LAV) [Abstract]. In: Program and Abstracts of the International Conference on Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986.

30. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.

31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

32. Rubella vaccination during pregnancy United States, 1971-1981, MMWR 31(35): 477-481, September 10, 1982.

33. Losonsky, G.A.; Fishaut, J.M.; Strussenberg, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666, 1982.

34. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 97: 465-467, 1980. (Letter)

35. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)

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

OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity to any component of the vaccine, including gelatin.27

Do not give MERUVAX (rubella virus vaccine live) II to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following vaccination (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and PRECAUTIONS, Pregnancy).

Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin). Febrile respiratory illness or other active febrile infection. However, the ACIP has recommended that all vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper respiratory infection with or without low-grade fever, or other low-grade febrile illness.26

Patients receiving immunosuppressive therapy. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses;26,28,29 cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states.

Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

REFERENCE

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

27. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin, J. Allergy Clin. Immunol. 91: 867-872, 1993.

28. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.

29. Krasinski, K.; Borkowsky, W.; Krugman, S.: Antibody following measles immunization in children infected with human T-cell lymphotropic virus-type III/lymphadenopathy associated virus (HTLV-III/LAV) [Abstract]. In: Program and Abstracts of the International Conference on Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986.

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

CLINICAL PHARMACOLOGY

Rubella is a common childhood disease, caused by rubella virus (togavirus), that may be associated with serious complications and/or death. For example, rubella during pregnancy may cause congenital rubella syndrome in the infants of infected mothers.

The impact of measles, mumps, and rubella vaccination on the natural history of each disease in the United States can be quantified by comparing the maximum number of rubella cases reported in a given year prior to vaccine use to the number of cases of each disease reported in 1995. For rubella, 57,686 cases reported in 1969 compared to 200 cases reported in 1995 resulted in a 99.65% decrease.3

Extensive clinical trials of rubella virus vaccines, prepared using RA 27/3 strain rubella virus, have been carried out in more than 28,000 human subjects (approximately 11,000 with MERUVAX (rubella virus vaccine live) II) in the U.S.A. and more than 20 additional countries. A single injection of the vaccine has been shown to induce rubella hemagglutination-inhibition (HI) antibodies in 97% or more of susceptible persons. However, a small percentage (1-5%) of vaccinees may fail to seroconvert after the primary dose (see also INDICATIONS, Recommended Vaccination Schedule).

Efficacy of rubella vaccine was established in a series of double-blind controlled field trials which demonstrated a high degree of protective efficacy.4 These studies also established that seroconversion in response to rubella vaccination paralleled protection from this disease.5

Following vaccination, antibodies associated with protection can be measured by neutralization assays, HI, or ELISA (enzyme linked immunosorbent assay) tests. Neutralizing and ELISA antibodies to rubella virus are still detectable in most individuals 11-13 years after primary vaccination.6,7 See INDICATIONS, Non-Pregnant Adolescents and Adult Females, for Rubella Susceptibility Testing.

The RA 27/3 rubella strain elicits higher immediate post-vaccination HI, complement-fixing and neutralizing antibody levels than other strains of rubella vaccine 8-14 and has been shown to induce a broader profile of circulating antibodies including anti-theta and anti-iota precipitating antibodies.15,16 The RA 27/3 rubella strain immunologically simulates natural infection more closely than other rubella vaccine viruses.16-18 The increased levels and broader profile of antibodies produced by RA 27/3 strain rubella virus vaccine appear to correlate with greater resistance to subclinical reinfection with the wild virus,16,18-20 and provide greater confidence for lasting immunity.

REFERENCES

3. Monthly Immunization Table, MMWR 45(1): 24-25, January 12, 1996.

4. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-136, February 1972.

5. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363, 1970.

6. Hillary, I.B.; Griffith, A.H.: Persistence of antibody 10 years after vaccination with Wistar RA 27/3 strain live attenuated rubella vaccine, Br. Med. J. 280(6231): 1580-1581, 1980.

7. Unpublished data from the files of Merck Research Laboratories.

8. Fogel, A.; Moshkowitz, A.; Rannon, L.; Gerichter, Ch. B.: Comparative trials of RA 27/3 and Cendehill rubella vaccines in adult and adolescent females, Am. J. Epidemiol. 93: 392-398, 1971.

9. Andzhaparidze, O.G.; Desyatskova, R.G.; Chervonski, G.I.; Pryanichnikova, L.V.: Immunogenicity and reactogenicity of live attenuated rubella virus vaccines, Am. J. Epidemiol. 91: 527-530, 1970.

10. Freestone, D.S.; Reynolds, G.M.; McKinnon, J.A.; Prydie, J.: Vaccination of schoolgirls against rubella. Assessment of serological status and a comparative trial of Wistar RA 27/3 and Cendehill strain live attenuated rubella vaccines in 13-year-old schoolgirls in Dudley, Br. J. Prev. Soc. Med. 29: 258-261, 1975.

11. Grillner, L.; Hedstrom, C.E.; Bergstrom, H.; Forssman, L.; Rigner, A.; Lycke, E.: Vaccination against rubella of newly delivered women, Scand. J. Infect. Dis. 5: 237-241, 1973.

12. Grillner, L.: Neutralizing antibodies after rubella vaccination of newly delivered women: a comparison between three vaccines, Scand. J. Infect. Dis. 7: 169-172, 1975.

13. Wallace, R.B.; Isacson, P.: Comparative trial of HPV-77, DE-5 and RA 27/3 live-attenuated rubella vaccines, Am. J. Dis. Child. 124: 536-538, 1972.

14. Lalla, M.; Vesikari, T.; Virolainen, M.: Lymphoblast proliferation and humoral antibody response after rubella vaccination, Clin. Exp. Immunol. 15: 193-202, 1973.

15. LeBouvier, G.L.; Plotkin, S.A.: Precipitin responses to rubella vaccine RA 27/3, J. Infect. Dis. 123: 220-223, 1971.

16. Horstmann, D.M.: Rubella: the challenge of its control, J. Infect. Dis. 123: 640-654, 1971.

17. Ogra, P.L.; Kerr-Grant, D.; Umana, G.; Dzierba, J.; Weintraub, D.: Antibody response in serum and nasopharynx after naturally acquired and vaccine-induced infection with rubella virus, N. Engl. J. Med. 285: 1333-1339, 1971.

18. Plotkin, S.A.; Farquhar, J.D.; Ogra, P.L.: Immunologic properties of RA 27/3 rubella virus vaccine, J. Am. Med. Assoc. 225: 585-590, 1973.

19. Liebhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; Horstmann, D.M.: Vaccination with RA 27/3 rubella vaccine. Persistence of immunity and resistance to challenge after two years, Am. J. Dis. Child. 123: 133-136, 1972.

20. Farquhar, J.D.: Follow-up on rubella vaccinations and experience with subclinical reinfection, J. Pediatr. 81: 460-465, 1972.

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

PATIENT INFORMATION

The health-care provider should provide the vaccine information required to be given with each vaccination to the patient, parent or guardian.

The health-care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS.

Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31

Pregnancy should be avoided for three months following vaccination, and patients should be informed of the reasons for this precaution (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females, CONTRAINDICATIONS, and PRECAUTIONS, Pregnancy).

31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

 

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

>

PATIENT INFORMATION

The health-care provider should provide the vaccine information required to be given with each vaccination to the patient, parent or guardian.

The health-care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS.

Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.31

Pregnancy should be avoided for three months following vaccination, and patients should be informed of the reasons for this precaution (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females, CONTRAINDICATIONS, and PRECAUTIONS, Pregnancy).

31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

 

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

Disclaimer

Meruvax Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RUBELLA VIRUS VACCINE - INJECTION

(roo-BEL-a)

COMMON BRAND NAME(S): Meruvax II

USES: This medication is used to help prevent infection from the rubella virus. Rubella (also known as German measles) is a common childhood infection. It may rarely cause problems in children. However, rubella infection in a pregnant woman may cause the unborn infant to die before birth or be born with physical defects. Vaccination during childhood can prevent these infections so that pregnant mothers who have never had rubella or been vaccinated are not exposed to rubella by others (e.g., their other children).

The rubella virus in this vaccine is alive, but it has been weakened (attenuated) so that it has a decreased ability to cause illness. This vaccine causes the body to make immune defensive substances (antibodies) against the rubella virus so that you will be protected from this infection.

The vaccine is recommended for all children 12 months and older and adults who have not already had rubella or been vaccinated.

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is usually given by injection under the skin by a health care professional.

Children who are vaccinated for rubella at 12 months or older should have a second live-vaccine injection (measles/mumps/rubella) just before entering elementary school.

Disclaimer

Meruvax Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site may occur. Other side effects may include fever, irritability, mild swollen glands (lymph nodes), measles-like rash, hives, tiredness, sore throat, dizziness, headache, nausea, vomiting, diarrhea, and body aches. These rubella-like symptoms may occur 11 to 20 days after vaccination and are usually mild and temporary, often persisting 1 to 5 days. If any of these effects last longer than 5 days or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. However, report all side effects to the doctor.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain/stiffness, tingling/numbness/pain in the arms/legs, fainting.

Tell your doctor immediately if any of these rare but very serious side effects occur: persistent joint pain/stiffness, easy bruising/bleeding within 2 weeks to 2 months of vaccination, swollen/painful testicles in men, inability to make muscles of the legs/arms work (paralysis), seizures, mental/mood changes (e.g., unusual behavior, severe drowsiness, stiff neck, visual sensitivity to light), decreased hearing, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the Meruvax (rubella virus vaccine live) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving rubella virus vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, gelatin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness with a high fever over 101 degrees F (38 degrees C), decreased immune function from other medications (see also Drug Interactions), decreased immune function from other illness (e.g., advanced HIV/AIDS, leukemia, lymphoma, other cancer affecting the bone marrow or lymph nodes), immune problems with certain white blood cells (T-cells), low or abnormal blood antibodies (hypogammaglobulinemia, dysgammaglobulinemia), untreated tuberculosis (TB) infection.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood clotting cells (platelets), HIV infection without symptoms, brain injury, seizures due to fever.

This medication must not be used during pregnancy. There is some risk that it may harm an unborn baby. If you have been vaccinated with rubella virus vaccine, you should not become pregnant for at least 3 months after the vaccination. Discuss the possible risks with your doctor.

The live, weakened virus in this vaccine is known to pass into breast milk. Rare cases of mild illness in nursing infants have been reported. Consult your doctor before breast-feeding.

Even if your nursing infant is exposed to rubella virus from breast-feeding, he/she should still receive the vaccine at 12 months.

Disclaimer

Meruvax Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This vaccine should not be used with medications that weaken the immune system such as: corticosteroids (e.g., prednisone doses over 7.5 milligrams a day), cancer chemotherapy, organ transplant drugs (e.g., cyclosporine, tacrolimus, mycophenolate), abatacept, efalizumab, adalimumab, infliximab.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before receiving the rubella virus vaccine. Vaccination can be received after these medications have been stopped for 30 days.

Wait at least 3 months before vaccination with rubella virus vaccine if you have received immune globulin (IG), Rho immune globulin D, or a blood/plasma transfusion. You may not develop enough antibodies to protect you from rubella infection.

If you have received a tuberculosis (TB) skin test, wait until the TB test is read by medical personnel before vaccination with rubella.

Other vaccines may be given at the same time as this vaccine, but they should be given with separate syringes and at different injection sites.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Keep vaccine records for all of your children, and provide them to their doctors and to your children after they are grown. This will prevent unnecessary re-vaccinations.

MISSED DOSE: It is important that your child receives each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember.

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

Meruvax Patient Information Including Side Effects

Brand Names: Meruvax II

Generic Name: rubella virus vaccine (Pronunciation: roo BEL a VYE rus vax EEN)

What is rubella virus vaccine (Meruvax)?

Rubella is a serious disease caused by a virus. It is spread from person to person through the air.

Rubella virus (also called German Measles) causes skin rash, fever, swollen glands, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

The rubella virus vaccine is used to help prevent this disease in adults and children who are at least 12 months old.

This vaccine works by exposing you to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Rubella virus vaccine is for use in children between the ages of 12 months and 6 years old, and in adults who have never received the vaccine or had the diseases.

Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor's instructions.

Like any vaccine, the rubella virus vaccine may not provide protection from disease in every person.

What are the possible side effects of rubella virus vaccines (Meruvax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • high fever (within a few hours or a few days after the vaccine);
  • swollen glands;
  • easy bruising or bleeding, unusual weakness;
  • joint swelling or stiffness that continues for several weeks after vaccination;
  • weakness, severe lower back pain, numbness or tingly feeling in your feet and spreading upward;
  • problems with hearing, vision, speech, swallowing, or bladder and bowel functions;
  • slow heart rate, trouble breathing, feeling like you might pass out;
  • seizure (black-out or convulsions); or
  • severe blistering, peeling, and red skin rash.

Less serious side effects include:

  • low fever, sore throat, cough, runny nose;
  • headache, dizziness, feeling tired or irritable;
  • nausea, vomiting, diarrhea;
  • joint or muscle pain;
  • numbness or tingly feeling; or
  • redness, pain, swelling, or a lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Meruvax (rubella virus vaccine live) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about this vaccine (Meruvax)?

Although immunization against rubella virus is available in a single vaccine, it may be best for you to receive a combination measles, mumps, and rubella (MMR) vaccine. Follow your doctor's instructions.

The first rubella virus vaccine is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. A measles, mumps, and rubella (MMR) vaccine should then be given before the child starts elementary school.

Adults born after 1956 should receive at least one measles, mumps, and rubella vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a minor cold or low fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers

Meruvax Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving this vaccine (Meruvax)?

You should not receive this vaccine if you are allergic to:

  • gelatin;
  • neomycin (Mycifradin, Neo-Fradin, Neo-Tab); or
  • if you have ever had a life-threatening allergic reaction to any vaccine containing rubella.

You should also not receive this vaccine if you have:

  • a blood cell disorder such as anemia;
  • blood or bone marrow cancer such as leukemia, lymphoma, and others;
  • severe active immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving chemotherapy or radiation; or
  • if you are pregnant.

Before receiving this vaccine, tell the doctor if you have:

  • thrombocytopenia purpura (easy bruising or bleeding);
  • active or untreated tuberculosis infection;
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you have received an immune globulin or other blood product within the past 3 months.

You can still receive a vaccine if you have a minor cold or low fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Do not receive this vaccine while you are breast-feeding a baby. Small amounts of the rubella virus contained in the vaccine can pass into breast milk and could harm a nursing baby.

Rubella virus vaccine contains albumin (part of the blood) and it may contain viruses and other infectious agents that can cause disease. Although donated human blood is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of receiving this vaccine.

How is this vaccine given (Meruvax)?

This vaccine is given as an injection (shot) under your skin. You will receive this injection in a doctor's office or other clinic setting.

Rubella virus vaccine is recommended for people in the following situations:

  • healthcare workers;
  • college students;
  • military personnel;
  • travelers on cruise ships or to destinations outside the U.S.;
  • a woman who is susceptible to rubella and has just had a baby; and
  • a child who has never been vaccinated against rubella and is in contact with a pregnant woman.

Adults born after 1956 should receive at least one measles, mumps, and rubella (MMR) vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

The first rubella virus vaccine is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. A measles, mumps, and rubella (MMR) vaccine should then be given before the child starts elementary school.

Your doctor may want you to receive an immune globulin (IG) injection within 3 months after you receive the rubella virus vaccine. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis. Tell any doctor who tests you if you have received a rubella virus vaccine within the past 4 to 6 weeks.

Side Effects Centers

Meruvax Patient Information including If I Miss a Dose

What happens if I miss a dose (Meruvax)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Meruvax)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Meruvax)?

An immune globulin (IG) injection should not be given at the same time as the rubella virus vaccine.

What other drugs will affect rubella virus vaccine (Meruvax)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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