M-m-r Ii

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • M-m-r Ii Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Measles, mumps and rubella viruses live, attenuated; for SC or IM inj; contains neomycin, human albumin; preservative-free.

    Pharmacological Class

    MMR.

    How Supplied

    Single dose vial—10 (w. diluent)

    Storage

    Store M-M-R II between -58°F and +46°F (-50°C to +8°C) to maintain potency. Use of dry ice may subject M-M-R II to temperatures colder than -58°F (-50°C).

    Prior to reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F (2°C to 8°C). Store accompanying diluent in the refrigerator (36°F to 46°F, 2°C to 8°C) or at room temperature (68°F to 77°F, 20°C to 25°C). Do not freeze the diluent.

    After reconstitution, administer the vaccine immediately. If not, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Mechanism of Action

    M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme linked immunosorbent assay (ELISA) tests.

    M-m-r Ii Indications

    Indications

    Measles, mumps and rubella immunization. 

    M-m-r Ii Dosage and Administration

    Adults and Children

    <12 months: not established. Each dose is 0.5mL. Give by SC or IM inj. First dose at 12–15 months of age, second dose at 4–6yrs of age (ACIP recommendations). Postexposure prophylaxis: give dose within 72hrs after exposure.

    Adults and Children

    Give by SC or IM injection only.

    Each dose is 0.5mL.

    First dose at 12–15 months of age, second dose at 4–6yrs of age (ACIP recommendations).

    • May administer the second dose before 4 years of age, provided there is a minimum interval of 1 month between the doses of measles, mumps and rubella virus vaccine, live.

    • Children who received an initial dose of measles, mumps and rubella vaccine prior to their first birthday should receive additional doses of vaccine at 12–15 months of age and at 4–6 years of age to complete the vaccination series.

    Post-exposure prophylaxis: administer a dose of M-M-R II vaccine within 72 hours after exposure.

    M-m-r Ii Contraindications

    Contraindications

    Gelatin or neomycin hypersensitivity. Active febrile illness with fever >101.3°F (>38.5°C). Active untreated tuberculosis. Immunosuppression. Pregnancy.

    M-m-r Ii Boxed Warnings

    Not Applicable

    M-m-r Ii Warnings/Precautions

    Warnings/Precautions

    Have epinephrine inj available. Previous or history of febrile seizures. Hypersensitivity to eggs. Thrombocytopenia or history of, after immunization with a previous dose of MMR vaccine. Defer vaccination if history of immunodeficiency until immunocompetent. Nursing mothers.

    Warnings/Precautions

    Febrile Seizure

    • Risk of fever and associated febrile seizure in the first 2 weeks after immunization.

    • A small increased risk of febrile seizure in children who experienced a previous febrile seizure (from any cause) or those with a family history of febrile seizures.

    Hypersensitivity to Eggs

    • Increased risk of immediate-type hypersensitivity reactions in individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (eg, hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion.

    • Evaluate risks/benefits before considering vaccination in these individuals.

    Thrombocytopenia

    • Reports of transient thrombocytopenia within 4 to 6 weeks after vaccination.

    • Carefully evaluate the risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, and rubella vaccine.

    Family History of Immunodeficiency

    • Defer vaccination in individuals with a family history of congenital or hereditary immunodeficiency until the immune status is evaluated and the individual is immunocompetent.

    Immune Globulins and Transfusions

    • Do not give immune globulins and other blood products concurrently with M-M-R II because these products may interfere with vaccine virus replication and decrease the expected immune response. 

    Pregnancy Considerations

    Risk Summary

    • Contraindicated for use in pregnant women.

    • Available data suggest the rates of major birth defects and miscarriage in women who received M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.

    Data

    • Human Data: A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978 through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine occurring 30 days before or at any time during pregnancy with known pregnancy outcomes.

    Nursing Mother Considerations

    Risk Summary

    • Not known whether measles or mumps vaccine virus is excreted in human milk.

    • Studies have shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breastfed infants.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from the underlying maternal condition.

    Pediatric Considerations

    • Not approved for use in individuals younger than 12 months of age.

    • Safety and efficacy of measles vaccine in infants younger than 6 months of age has not been established.

    • Safety and efficacy of mumps and rubella vaccine in infants younger than 12 months of age have not been established.

    M-m-r Ii Pharmacokinetics

    See Literature

    M-m-r Ii Interactions

    Interactions

    Avoid concomitant immunosuppressants, including high dose corticosteroids. Concomitant immune globulins, other blood products: may interfere with the immune response. May interfere with tuberculin test; if necessary, administer the test before, simultaneously with, or at least 4–6wks after vaccination. May be administered with other live viral vaccines; if not given concurrently, give M-M-R II vaccine 1 month before or after other live viral vaccines.

    M-m-r Ii Adverse Reactions

    Adverse Reactions

    Fever, rash, malaise, sore throat, headache, local reactions, arthritic symptoms, parotitis, orchitis, thrombocytopenia, purpura; encephalitis (rare).

    Adverse Reactions

    Body as a Whole

    • Panniculitis; atypical measles; fever; headache; dizziness; malaise; irritability.

    Cardiovascular System 

    • Vasculitis.

    Digestive System

    • Pancreatitis; diarrhea; vomiting; parotitis; nausea.

    Hematologic and Lymphatic Systems

    • Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.

    Immune System

    • Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.

    Musculoskeletal System 

    • Arthritis; arthralgia; myalgia.

    Nervous System

    • Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia; syncope.

    Respiratory System

    • Pneumonia; pneumonitis; sore throat; cough; rhinitis.

    Skin

    • Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).

    Special Senses — Ear

    • Nerve deafness; otitis media.

    Special Senses — Eye

    • Retinitis; optic neuritis; papillitis; conjunctivitis.

    Urogenital System 

    • Epididymitis; orchitis.

    M-m-r Ii Clinical Trials

    Clinical Trials

    Immunogenicity

    • Clinical studies included 284 seronegative children aged 11 months to 7 years who were found to be immunogenic following administration of M-M-R II vaccine. These studies showed 95%, 96%, and 99% antibody responses to measles H1, mumps, and rubella HI, respectively, among susceptible individuals.

    Clinical Study of Infants 6 to 15 Month of Age

    • Infants 6 through 15 months of age born to mothers vaccinated with a measles vaccine in childhood were evaluated in a clinical study.

    • 74% of the 6 month old infants achieved detectable neutralizing antibody titers following infant and toddler vaccination subcutaneously with Measles Virus Vaccine, Live.

    • 100% of the 15 month old infants achieved detectable neutralizing antibody titers following vaccination with Measles Virus Vaccine, Live or M-M-II vaccine.

    • Revaccination of the 6 month old infants of immunized mothers with M-M-R II vaccine achieved antibody titers similar to that of the 15 month old infants

    Open Label Clinical Trial in Children 12 Through 18 Months of Age

    • The clinical trial (NCT00432523) included 752 children 12 through 18 months of age who received M-M-R II either intramuscularly (n=374) or subcutaneously (n=378), concomitantly with Varivax. Antibody responses to measles, mumps, and rubella viruses were measured by ELISAs using sera obtained 6 weeks post-vaccination.

    • For anti-measles virus, anti-mumps virus and anti-rubella virus, seroresponse rates were defined as the percentage of children seronegative at baseline who achieved antibody titers above the respective seroresponse threshold for each assay 6 weeks post vaccination. Seroresponse thresholds were defined as 255 mIU/mL, 10 EU/mL, and 10 IU/mL for anti-measles virus, anti-mumps virus, and anti-rubella virus antibodies, respectively. 

    • In a post hoc analysis, mumps and rubella viruses for the intramuscular group achieved noninferiority to the subcutaneous group for seroresponse rates (the lower bound of the 95% confidence interval for the difference in seroresponse rates [intramuscular group minus subcutaneous group] ≥-5%). The seroresponse rate to the measles virus did not achieve noninferiority but it narrowly missed meeting the post hoc criterion of -5%.

    • After intramuscular administration, >90% seroresponse rates were achieved for measles, mumps, and rubella antigens. The point estimates of the proportions of children achieving antibody titers above the seroresponse thresholds for measles, mumps, and rubella viruses were as follows: 94.3%, 97.7%, and 98.1%, respectively, in the intramuscular group and 96.1%, 98.1%, and 98.1%, respectively, in the subcutaneous group.

    M-m-r Ii Note

    Not Applicable

    M-m-r Ii Patient Counseling

    Patient Counseling

    • Inform the patient, parent, or guardian of the benefits and risks associated with vaccination. 

    • Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine or other measles-, mumps-, or rubella-containing vaccines. 

    • Question females of reproductive potential regarding the possibility of pregnancy. Inform female patients to avoid pregnancy for 1 month following vaccination. 

    • Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100% protection from measles, mumps, and rubella infection. 

    • Instruct patients, parents, or guardians to report any adverse reactions to their health-care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at https://www.vaers.hhs.gov.

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