WARNINGS
The physician should be alert to the temperature elevation which may occur following vaccination (see ADVERSE REACTIONS).
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. Although there is a theoretical risk for transmission of Creutzfeldt-Jacob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin.
Hypersensitivity to Neomycin
The AAP states, "Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine. Most often, however, neomycin allergy manifests as a contact dermatitis, which is a delayed-type (cell-mediated) immune response rather than anaphylaxis. In such persons, an adverse reaction to neomycin in the vaccine would be an erythematous, pruritic nodule or papule, 48 to 96 hours after vaccination. A history of contact dermatitis to neomycin is not a contraindication to receiving measles vaccine."
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).
PRECAUTIONS
General
Adequate treatment provisions including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
Special care should be taken to ensure that the injection does not enter a blood vessel.
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 vaccine virus to infants via breast milk has been documented (see Nursing Mothers).
Children and young adults who are known to be infected with human immunodeficiency viruses and are not immunosuppressed may be vaccinated. However, 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).
Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human). However, susceptible postpartum patients who received blood products may receive MERUVAX II prior to discharge provided that a repeat HI titer is drawn 6-8 weeks after vaccination to insure seroconversion. Similarly, although studies with other live rubella virus vaccines suggest that MERUVAX II may be given in the immediate postpartum period to those non-immune women who have received anti-Rho (D) globulin (human) without interfering with vaccine effectiveness, a follow-up post-vaccination HI titer should also be determined.
It has been reported that attenuated rubella virus vaccine, live, 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 MERUVAX II.
Individuals with active untreated tuberculosis should not be vaccinated.
As for any vaccine, vaccination with MERUVAX II may not result in protection in 100% of vaccinees.
The health-care provider should determine the current health status and previous vaccination history of the vaccinee.
The health-care provider should question the patient, parent, or guardian about reactions to a previous dose of MERUVAX II or other measles-, mumps-, or rubella-containing vaccines. Information For Patients
The health-care provider should provide the vaccine information required to be given with each vaccination to the patient, parent or guardian.
The health-care provider should inform the patient, parent or guardian of the benefits and risks associated with vaccination. For risks associated with vaccination see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS.
Patients, parents or guardians should be instructed to report any serious adverse reactions to their health-care provider who in turn should report such events to the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967.
Pregnancy should be avoided for three months following vaccination, and patients should be informed of the reasons for this precaution (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females, CONTRAINDICATIONS, and PRECAUTIONS, Pregnancy).
Laboratory Tests
See INDICATIONS AND USAGE, Non-Pregnant Adolescents and Adult Females, for Rubella Susceptibility Testing, and CLINICAL PHARMACOLOGY.
Immunosuppressive Therapy
The immune status of patients about to undergo immunosuppressive therapy should be evaluated so that the physician can consider whether vaccination prior to the initiation of treatment is indicated. (see CONTRAINDICATIONS and PRECAUTIONS).
The ACIP has stated that "patients with leukemia in remission who have not received chemotherapy for at least 3 months may receive live-virus vaccines. Short-term (<2 weeks), low- to moderate-dose systemic corticosteroid therapy, topical steroid therapy (e.g., nasal, skin), long-term alternate-day treatment with low to moderate doses of short-acting systemic steroid, and intra-articular, bursal, or tendon injection of corticosteroids are not immunosuppressive in their usual doses and do not contraindicate the administration of rubella vaccine."
Immune Globulin
Administration of immune globulins concurrently with MERUVAX II may interfere with the expected immune response.
See also PRECAUTIONS, General.
Carcinogenesis, Mutagenesis, Impairment of Fertility
MERUVAX II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
Pregnancy Pregnancy Category C
Animal reproduction studies have not been conducted with MERUVAX II. It is also not known whether MERUVAX II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There is evidence suggesting transmission of rubella vaccine viruses to products of conception. Therefore, rubella vaccine should not be administered to pregnant females (see INDICATIONS AND USAGE, Non-Pregnant Adolescent and Adult Females and 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: 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.
Nursing Mothers
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 MERUVAX II is administered to a nursing woman. Pediatric Use
Safety and effectiveness in infants below the age of 12 months have not been established (see INDICATIONS AND USAGE, Recommended Vaccination Schedule).
Geriatric Use
Clinical studies of MERUVAX II did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects.
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