ProQuad 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 ProQuad to persons with individual or family history 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 that may occur following vaccination (see SIDE EFFECTS).
The safety and efficacy of ProQuad have not been established in individuals who are known to be infected with human immunodeficiency viruses with or without evidence of immunosuppression (see CONTRAINDICATIONS).
The duration of protection from measles, mumps, rubella, and varicella infection after vaccination with ProQuad is unknown (see PHARMACOLOGY under Actions).
As for any vaccine, vaccination with ProQuad may not result in protection in all vaccine recipients.
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 NURSING MOTHERS under Use in Pregnancy & Lactation).
There are no reports of transmission of the more attenuated Enders' Edmonston strain of measles virus or the Jeryl Lynn strain of mumps virus from vaccine recipients to susceptible contacts.
Post-licensing experience suggests that transmission of varicella vaccine virus (Oka/Merck) resulting in varicella infection including disseminated disease may occur rarely between vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella including healthy, as well as high-risk individuals.
High-risk individuals susceptible to varicella include: Immunocompromised individuals (see CONTRAINDICATIONS); 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, whenever 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.
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 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: No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported in post-marketing experience after primary vaccination with ProQuad. In addition, cases of thrombocytopenia have been reported after primary vaccination or revaccination with measles vaccine; with measles, mumps, and rubella vaccine; and with varicella vaccine. 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 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 with ProQuad in such cases (see SIDE EFFECTS).
Febrile seizures: In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed compared to concomitant administration of measles, mumps, rubella and varicella vaccines.
Post-Exposure Prophylaxis: The safety and efficacy of ProQuad for use after exposure to measles, mumps, rubella, or varicella have not been established. No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
Females of Childbearing Age: In females of childbearing age, pregnancy should be avoided for 3 months following vaccination (see PREGNANCY under Use in Pregnancy & Lactation).
Adolescents and Adults: No clinical data are available on the safety, immunogenicity, and efficacy of ProQuad in adolescents and adults.
Tuberculin Test: 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 ProQuad.
Tuberculosis: Children under treatment for tuberculosis have not experienced exacerbation of the disease when vaccinated with live measles virus vaccine; no studies have been reported to date of the effect of measles virus vaccines on children with untreated tuberculosis.
Effects on Ability to Drive and Use Machines: There are no data to suggest that ProQuad affects the ability to drive or operate machinery.
Use in Children: ProQuad has not been studied in infants less than 12 months of age and is not recommended for administration in this age group.