M-R-Vax Warnings, Precautions, Pregnancy, Nursing, Abuse - Measles and Rubella Virus Vaccine Live

M-R-Vax Warnings, Precautions, Pregnancy, Nursing, Abuse - Measles and Rubella Virus Vaccine Live

WARNINGS

No Information Provided.

General

Adequate treatment provisions including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

Due caution should be employed in administration of M-R-VAX 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 .)

Children and young adults who are known to be infected with human immunodeficiency viruses but without overt clinical manifestations of immunosuppression may be vaccinated; however, the vaccinees should be monitored closely for vaccine-preventable diseases because immunization may be less effective than for uninfected persons.

Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.

Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7-28 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 Nursing Mothers  ).

There are no reports of transmission of live attenuated measles virus from vaccinees to susceptible contacts.

It has been reported that live attenuated measles 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-R-VAX 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-R-VAX II may not result in seroconversion in 100% of susceptible persons given the vaccine.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with M-R-VAX II. It is also not known whether M-R-VAX 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; futhermore, pregnancy should be avoided for three months following vaccination (see 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; (2) Reports have indicated that contracting of natural measles during pregnancy enhances fetal risk. Increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to natural 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.

Nursing Mothers

It is not known whether measles 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-R-VAX II is administered to a nursing woman.