"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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-Jakob 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."30
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).
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.22 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).28,29
Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).30 However, susceptible postpartum patients who received blood products may receive MERUVAX (rubella virus vaccine live) II prior to discharge provided that a repeat HI titer is drawn 6-8 weeks after vaccination to ensure seroconversion. Similarly, although studies with other live rubella virus vaccines suggest that MERUVAX (rubella virus vaccine live) II may be given in the immediate postpartum period to those nonimmune 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 (rubella virus vaccine live) II.
Individuals with active untreated tuberculosis should not be vaccinated.
As for any vaccine, vaccination with MERUVAX (rubella virus vaccine live) 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 (rubella virus vaccine live) II or other measles-, mumps-, or rubella-containing vaccines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
MERUVAX (rubella virus vaccine live) II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with MERUVAX (rubella virus vaccine live) II. It is also not known whether MERUVAX (rubella virus vaccine live) 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.32 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.32
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.33 In the infants with serological evidence of rubella infection, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.34,35 Caution should be exercised when MERUVAX (rubella virus vaccine live) II is administered to a nursing woman.
Safety and effectiveness in infants below the age of 12 months have not been established (see INDICATIONS AND USAGE, Recommended Vaccination Schedule).
Clinical studies of MERUVAX (rubella virus vaccine live) 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.
22. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MMWR 39(RR-15): 1-18, November 23, 1990.
28. Center for Disease Control: Immunization of Children Infected with Human T-Lymphotropic Virus Type III/Lymphadenopathy-Associated Virus, Annals of Internal Medicine, 106: 75-78, 1987.
29. Krasinski, K.; Borkowsky, W.; Krugman, S.: Antibody following measles immunization in children infected with human T-cell lymphotropic virus-type III/lymphadenopathy associated virus (HTLV-III/LAV) [Abstract]. In: Program and Abstracts of the International Conference on Acquired Immunodeficiency Syndrome, Paris, France, June 23-25, 1986.
30. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.
31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.
32. Rubella vaccination during pregnancy United States, 1971-1981, MMWR 31(35): 477-481, September 10, 1982.
33. Losonsky, G.A.; Fishaut, J.M.; Strussenberg, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666, 1982.
34. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 97: 465-467, 1980. (Letter)
35. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.
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