Selected Safety Information
Selected Safety Information for M-M-R® II
MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE (M-M-R®II) is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.1
FOR SUBCUTANEOUS OR INTRAMUSCULAR ADMINISTRATION Do not inject intravascularly.
Do not give immune globulin (IG) concurrently with MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE (M-M-R II).
The dose for any age is 0.5 mL administered subcutaneously or intramuscularly.
Recommended Vaccination Schedule:
Individuals first vaccinated at 12 months of age or older should be revaccinated at 4 to 6 years of age since increased risk of exposure typically occurs around elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose.1
Hypersensitivity to any component of the vaccine, including gelatin.
Do not give MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE (M-M-R®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 one month following vaccination.
Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin).
Any febrile respiratory illness or other active febrile infection.
Active untreated tuberculosis.
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; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely 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.1
Adequate treatment provisions including epinephrine injection (1:1000) should be available for immediate use should an anaphylactic or anaphylactoid reaction occur. Due caution should be employed in administration of MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE (M-M-R®II) to persons with individual or family histories of convulsions, a history of cerebral injury 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.1
COMMON
Burning and/or stinging of short duration at the injection site.
OCCASIONAL
Body as a whole: Fever (101°F [38.3°C] or higher); Skin: Rash, or measles-like rash, usually minimal but may be generalized; Generally, fever, rash, or both appear between the 5th and the 12th day.
RARE
Body as a whole: Mild local reactions such as erythema, induration and tenderness; sore throat, malaise, atypical measles, syncope, irritability; Cardiovascular: Vasculitis; Digestive: Parotitis, nausea, vomiting, diarrhea; Hematologic/Lymphatic: Regional lymphadenopathy, thrombocytopenia, purpura; Hypersensitivity: Allergic reactions such as wheal and flare at injection site, anaphylaxis and anaphylactoid reactions, as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm, urticaria in individuals with or without an allergic history; Musculoskeletal: Arthralgia and/or arthritis (usually transient and rarely chronic [see below]), myalgia; Nervous/Psychiatric: Febrile convulsions in children, afebrile convulsions or seizures, headache, dizziness, paresthesia, polyneuritis, polyneuropathy, Guillain-Barre syndrome, ataxia, acute disseminated encephalomyelitis (ADEM), transverse myelitis, aseptic meningitis (see below), measles inclusion body encephalitis (MIBE), encephalitis/encephalopathy (see below); Respiratory System: Pneumonia, pneumonitis, cough, rhinitis; Skin: Erythema multiforme, Stevens-Johnson syndrome, Henoch-Schönlein purpura, Acute Hemorrhagic Edema of Infancy, vesiculation at injection site, swelling, pruritus; Special senses: Forms of optic neuritis, including retrobulbar neuritis, papillitis, and retinitis; ocular palsies, otitis media, nerve deafness, conjunctivitis; Urogenital: Epididymitis, orchitis; 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 in healthy individuals. 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 MEASLES, MUMPS, AND RUBELLA VIRUS VACCINE LIVE (M-M-R®II) during 1982 to 1993.1
Before administering M-M-R® II, please read the full prescribing information.
More about M-M-R®II
Efficacy Data
M-M-R® II vaccine helping to protect generations of children from 3 childhood disease – measles, mumps, and rubella
Indication
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) is a vaccine indicated for active immunization for the prevention of measles,
Reference: 1. M-M-R II LPC. S-IPC-V205C-I-022020.
PH-MMR-00015 Oct/2024