Download MMR II package insert here
http://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdfM-M-R® II
(MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE)
DESCRIPTION(Measles, Mumps, and Rubella Virus Vaccine Live) is a live virus vaccine for vaccination against measles (rubeola), mumps, and rubella (German measles).
M-M-R II is a sterile lyophilized preparation of (1) ATTENUVAX® (Measles Virus Vaccine Live), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX® (Mumps Virus Vaccine Live), the Jeryl Lynn™ (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX® II (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts.{1,2}
The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as stabilizer and neomycin. The growth medium for rubella is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum] containing recombinant human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.
The cells, virus pools, and fetal bovine serum are all screened for the absence of adventitious agents. The reconstituted vaccine is for subcutaneous administration. Each 0.5 mL dose contains not less than 1,000 TCID
50 (tissue culture infectious doses) of measles virus; 12,500 TCID 50 of mumps virus; and 1,000 TCID
50 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), recombinant 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. M-M-R II, when
reconstituted as directed, is clear yellow.
....
CONTRAINDICATIONSHypersensitivity to any component of the vaccine, including gelatin.{40}
Do not give M-M-R II to pregnant females; the possible effects of the vaccine on fetal development
are unknown at this time. If vaccination of post pubertal 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.{41}
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 orlymphatic 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;{41-43}cellular immune deficiencies; and hypogamm aglobulinemic and dysgammaglobulinemic
states. Measles inclusion body encephalitis{44} (MIBE), pneumonitis{45} and death as a direct
consequence of disseminated measles vaccine virus infection have been reported in
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine.
Individuals with a family history of congenital or hereditary immunodeficiency, until the immune
competence of the potential vaccine recipient is demonstrated.
WARNINGSDue caution should be employed in administration of M-M-R II
to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination (see ADVERSE REACTIONS).
Hypersensitivity to Eggs
Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with
a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth
and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an
enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of
chick embryo antigen. The potential risk to benefit ratio should be care fully evaluated before considering
vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate
treatment on hand should a reaction occur (see PRECAUTIONS).{46}
However, the AAP has stated, "Most children with a history of anaphylactic reactions to eggs have no
untoward reactions to measles or MMR vaccine. Persons are not at increased risk if they have egg
allergies that are not anaphylactic, and they should be vaccinated in the usual manner. In addition, skin
testing of egg-allergic children with vaccine has not been predictive of which children will have an
immediate hypersensitivity reaction...
Persons with allergies to chickens or chicken feathers are not at increased risk of reaction to the vaccine."{47}
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."{47}
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).
PRECAUTIONSGeneral
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.
Children and young adults who are known to be infected with human immunodeficiency viruses and
are not immuno suppressed 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).{42,43}
Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or
administration of immune globulin (human).{47}
Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in
the majority of susceptible individuals 7 to 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.{33}
However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see
Nursing Mothers).
There are no reports of transmission of live attenuated measles or mumps viruses from vaccines to
susceptible contacts.
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
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 M-M-R II.
Children under treatment for tuberculosis have not experienced exacerbation of the disease when
immunized with live measles virus vaccine;{48} no studies have been reported to date of the effect of
measles virus vaccines on untreated tuberculous children. However, individuals with active untreated
tuberculosis should not be vaccinated.
As for any vaccine, vaccination with M-M-R II may not result in protection in 100% of vaccines.
The health-care provider should determine the current health status and previous vaccination history
of the vaccine.
The health-care provider should question the patient, parent, or guardian about reactions to a previous
dose of M-M-R II or other measles-, mumps-, or rubella-containing vaccines.
Information for Patients
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, and
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.{49}
Pregnancy should be avoided for 3 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).
Laboratory Tests
See INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females, for Rubella
Susceptibility Testing, and CLINICAL PHARMACOLOGY. Drug Interactions
See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.
Immuno suppressive Therapy
The immune status of patients about to undergo immuno suppressive therapy should be evaluated so
that the physician can consider what her 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 [measle s, mumps, or rubella vaccine]."{33,34,37}
Immune Globulin
Administration of immune globulins concurrently with M-M-R II may interfere with the expected
immune response.{33,34,47}
See also PRECAUTIONS,
General
Carcinogenesis, Mutagenesis,
Impairment of Fertility M-M-R 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 M-M-R II. It is also not known whether
M-M-R II can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy
should be avoided for 3 months following vaccination (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: (1) 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;{50} (2) Mumps infection during the first trimester of
pregnancy may increase the rate of spontaneous abortion. Although mumps vaccine virus has been
shown to infect the placenta and fetus, there is no evidence that it causes congenital malformations in
humans;{37} and (3) Reports have indicated that contracting wild-type measles during pregnancy
enhances fetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity
have been observed subsequent to infection with wild-type measles during pregnancy.{51,52} There are
no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy. However, it would
be prudent to assume that the vaccine strain of virus is also capable of inducing adverse fetal effects.
Nursing Mothers
It is not known whether measles or mumps vaccine virus is secreted in human milk. 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.{53} In the infants with serological evidence of
rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of
acquired rubella.{54,55} Caution should be exercised when M-M-R II is administered to a nursing
woman.
Pediatric Use
Safety and effectiveness of measles vaccine in infants below the age of
6 months have not been established (see also CLINICAL PHARMACOLOGY).
Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months
of age have not been established.
Geriatric Use
Clinical studies of M-M-R 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 elder
ly and younger subjects.
