M-M-R II Special Precautions

General: 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 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 (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 in 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 carefully evaluated before considering vaccination in such cases. Such individuals may be vaccinated with extreme caution, having adequate treatment on hand should a reaction occur.
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).
Other: Children and young adults who are known to be infected with human immunodeficiency viruses and are not immunosuppressed may be vaccinated. However, the 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).
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. However, transmission of the rubella vaccine virus to infants via breast milk has been documented (see Use in Lactation as follows).
There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees 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 any time before, simultaneously with, or at least 4 to 6 weeks after M-M-R II.
Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine, no studies have been reported to date of the effect of measles virus vaccines on untreated tuberculous children.
As for any vaccine, vaccination with M-M-R II may not result in protection in 100% of vaccinees.
Use in Pregnancy: It is 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 one month following vaccination (see CONTRAINDICATIONS).
In an 18-year survey involving over 1200 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 683 received the Wistar RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome. Additional data from post-marketing reports and published observational studies have not identified abnormalities compatible with congenital rubella syndrome in patients who received M-M-R II. 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. Reports have indicated that contracting of 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. 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.
Use in Lactation: 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. In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella. Caution should be exercised when M-M-R II is administered to a nursing woman.
Use in Children: Safety and effectiveness of measles vaccine in infants below the age of 6 months have not been established. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established.