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MERUVAX

 * Generic Name: rubella virus vaccine live
 * Brand Name: Meruvax

Last updated on RxList: 7/13/2021

home drugs a-z list meruvax (rubella virus vaccine live) drug

   
   
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DRUG SUMMARY

WHAT IS MERUVAX?

Meruvax II (rubella virus) Vaccine Live is a live vaccination used to help
prevent rubella (also called German Measles) in adults and children who are at
least 12 months old. Meruvax II Vaccine is available in generic form.

WHAT ARE SIDE EFFECTS OF MERUVAX?

Common side effects of Meruvax II Vaccine include injection site reactions
(pain, redness, swelling, or a lump), fever, irritability, mild swollen glands
(lymph nodes), measles-like rash, hives, tiredness, sore throat, dizziness,
headache, nausea, vomiting, diarrhea, body aches, cough, runny nose, tiredness,
joint or muscle pain, or numbness or tingly feeling. These rubella-like symptoms
may occur 11 to 20 days after vaccination with Meruvax II and are usually mild
and temporary, persisting 1 to 5 days.

DOSAGE FOR MERUVAX

The dose of Meruvax II for any age is 0.5 mL administered subcutaneously,
preferably into 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.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH MERUVAX?

Meruvax II may interact with steroids, medicines to treat or prevent organ
transplant rejection, or medications to treat psoriasis, rheumatoid arthritis,
or other autoimmune disorders. Tell your doctor all medications and supplements
you use, and all other vaccines you have recently received.

MERUVAX DURING PREGNANCY OR BREASTFEEDING

Meruvax II must not be used during pregnancy. It may harm a fetus. If you have
been vaccinated with rubella virus vaccine, you should not become pregnant for
at least 3 months after the vaccination. The live, weakened virus in this
vaccine passes into breast milk. Rarely, mild illness in nursing infants has
been reported. Consult your doctor before breastfeeding. Even if your nursing
infant is exposed to rubella virus from breastfeeding, he/she should still
receive the vaccine at 12 months.

ADDITIONAL INFORMATION

Our Meruvax II (rubella virus) Vaccine Live Side Effects Drug Center provides a
comprehensive view of available drug information on the potential side effects
when taking this medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications
 * Dosage
 * Side Effects
 * Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide

Wistar RA 27/3 Strain


DESCRIPTION FOR MERUVAX

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.

REFERENCES

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.

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.




USES FOR MERUVAX

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 FOR MERUVAX

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




SIDE EFFECTS FOR MERUVAX

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.


DRUG INTERACTIONS FOR MERUVAX

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.




WARNINGS FOR MERUVAX

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 FOR MERUVAX

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)


OVERDOSE INFORMATION FOR MERUVAX

No information provided.


CONTRAINDICATIONS FOR MERUVAX

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.


CLINICAL PHARMACOLOGY FOR MERUVAX

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.


PATIENT INFORMATION FOR MERUVAX

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.

 


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