ProQuad Special 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, 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 or anaphylactoid reaction occur. Vaccination with a live attenuated vaccine, such as varicella, can result in an extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressive doses of corticosteroids.
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 safety and efficacy of ProQuad for use after exposure to measles, mumps, rubella or varicella have not been established.
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. Children with egg allergy are at low risk for anaphylactic reactions to measles-containing vaccines (including MMR), and skin testing of children allergic to eggs is not predictive of reactions to MMR vaccine. Persons with allergies to chickens or feathers are not at increased risk of reaction to the vaccine.
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).
Post-Exposure Prophylaxis: No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella. However, post-exposure prophylaxis has been demonstrated for measles and varicella with a measles-containing vaccine and varicella-containing vaccine, respectively, when administered to the susceptible individuals within 3 days of exposure.
Females of Childbearing Age: In females of childbearing age, pregnancy should be avoided for 3 months following vaccination (see 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.
Use with other vaccines: There are insufficient data to support concomitant vaccination with diphtheria, tetanus and acellular pertussis vaccine.
Carcinogenicity, Mutagenicity, and impairment of fertility: ProQuad has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
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.
Use in the Elderly: ProQuad is not indicated for use in the geriatric population (> age 65).