HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approval: 1978
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubella containing vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
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immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3๏ฐF
(>38.5๏ฐC).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals 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 M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential 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 {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during post approval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; 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 ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
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Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing
panencephalitis (SSPE); Guillain-Barrรฉ Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis;
polyneuropathy; ocular palsies; paresthesia.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schรถnlein purpura;
erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema,
swelling and vesiculation).
Special Senses โ Ear
Nerve deafness; otitis media.
Special Senses โ Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.