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Proquad

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Proquad

Proquad

WARNINGS

Caution should be exercised in administering ProQuad (measles mumps rubella varicella vaccine live) to persons with a history of cerebral injury, individual or family history of convulsions, or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevations that may occur following vaccination (see ADVERSE REACTIONS). Vaccination with a live attenuated vaccine, such as varicella, can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressive drugs.

Hypersensitivity to Eggs

Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic or other immediate hypersensitivity 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 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; adequate treatment should be readily available should a reaction occur (see PRECAUTIONS).11

Children with egg allergy are at low risk for anaphylactic reactions to measles-containing vaccines (including M-M-R II), and skin testing of children allergic to eggs is not predictive of reactions to M-M-R II vaccine. Persons with allergies to chickens or feathers are not at increased risk of reaction to the vaccine.11

Hypersensitivity to Neomycin

Most often, neomycin allergy manifests as a contact dermatitis, which is not a contraindication to receiving measles-, mumps-, rubella- or varicella-containing vaccine.

Thrombocytopenia

No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad (measles mumps rubella varicella vaccine live) . Cases of thrombocytopenia have been reported after use of measles vaccine, measles, mumps and rubella vaccine and after varicella vaccination. Post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses. Serologic testing for antibody to measles, mumps or rubella should be considered in order to determine if additional doses of vaccine are needed. The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad (measles mumps rubella varicella vaccine live) in such cases.

Theoretical Risk of Transmission of Creutzfeldt-Jakob Disease

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.

PRECAUTIONS

General

Prior to administering the vaccine, obtain the prospective vaccinee's vaccination history and determine whether the individual had any previous reactions to any vaccine including ProQuad (measles mumps rubella varicella vaccine live) , VARIVAX or any measles-, mumps- or rubella-containing vaccines.

Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic reaction occur.

Vaccination with a live attenuated vaccine, such as varicella, can result in a more extensive vaccine- associated rash or disseminated disease in individuals on immunosuppressive doses of corticosteroids.

The safety and efficacy of ProQuad (measles mumps rubella varicella vaccine live) for use after exposure to measles, mumps, rubella or varicella have not been established.

The safety and efficacy of ProQuad (measles mumps rubella varicella vaccine live) for use in children and young adults who are known to be infected with human immunodeficiency viruses have not been established (see CONTRAINDICATIONS).

Transmission

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 PRECAUTIONS, Nursing Mothers).

There are no reports of transmission of the more attenuated Ender's Edmonston strain of measles virus or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.

Post-licensing experience with VARIVAX suggests that transmission of varicella vaccine virus may occur rarely between healthy vaccine recipients who develop a varicella-like rash and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella.

High-risk individuals susceptible to varicella include:

  • Immunocompromised individuals;
  • Pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection;
  • Newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection.

Vaccine recipients should attempt to avoid, to the extent possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.

Carcinogenesis, Mutagenesis, Teratogenicity, Impairment of Fertility

ProQuad (measles mumps rubella varicella vaccine live) has not been evaluated for its carcinogenic, mutagenic or teratogenic potential, or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with ProQuad (measles mumps rubella varicella vaccine live) .

It is also not known whether ProQuad (measles mumps rubella varicella vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, ProQuad (measles mumps rubella varicella vaccine live) should not be administered to pregnant females. If vaccination of post-pubertal females is undertaken, pregnancy should be avoided for 3 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) Reports have indicated that contracting wild-type 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; (2) 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;12 (3) 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 RA27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome;13 and (4) Wild-type varicella can sometimes cause congenital varicella infection.

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to varicella-containing vaccine (Oka/Merck). In the first 9 years of the Pregnancy Registry for varicella vaccine (Oka/Merck), of 129 seronegative women and 423 women of unknown serostatus who received varicella vaccine during pregnancy or within 3 months before pregnancy, none had newborns with abnormalities compatible with congenital varicella syndrome.

Patients and health care providers are encouraged to report any exposure to varicella-containing vaccine (Oka/Merck) during pregnancy by calling (800) 986-8999.

Nursing Mothers

The secretion of viruses in human milk has not been studied in measles and mumps vaccine viruses. Studies have shown that lactating postpartum women vaccinated with live rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. Limited evidence in the literature suggests that virus, viral DNA, or viral antigen could not be detected in the breast milk of women who were vaccinated postpartum with the vaccine strain of varicella virus.14-15 For additional information on transmission of vaccine virus from vaccine recipients to susceptible infants, see Transmission. ProQuad (measles mumps rubella varicella vaccine live) should not be administered to nursing women.

Pediatric Use

No clinical data are available on the safety, immunogenicity, and efficacy of ProQuad (measles mumps rubella varicella vaccine live) in children less than 12 months of age.

Geriatric Use

ProQuad (measles mumps rubella varicella vaccine live) is not indicated for use in the geriatric population ( > age 65).

REFERENCES

11. Committee on Infectious Diseases, American Academy of Pediatrics. In: Pickering LK, Baker CJ, Overturf GD, et al., eds. Red . Book: 2003 Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics. 419-29,2003.

12. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention. MMWR. 38(22):388-392, 397-400, 1989.

13. Rubella vaccination during pregnancy-United States, 1971-1986. MMWR Morb Mortal Wkly Rep. 36(28):457-61, 1987.

14. Bohlke K, Galil K, Jackson LA, et al. Postpartum varicella vaccination: Is the vaccine virus excreted in breast milk? Obstetrics and Gynecology. 102(5): 970-977, 2003.

15. Dolbear GL, Moffat J, Falkner C and Wojtowycz M. A Pilot Study: Is attenuated varicella virus present in breast milk after postpartum immunization? Obstetrics and Gynecology. 101(4 Suppl.): 47S-47S, 2003.

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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