Proquad

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Proquad Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Measles, mumps, rubella, and varicella viruses live, attenuated; lyophilized pwd for SC or IM inj after reconstitution; contains neomycin (trace), human albumin; preservative-free.

    Pharmacological Class

    MMR+Var.

    How Supplied

    Single-dose vials—10 (w. diluent)

    Storage

    • Prior to reconstitution, store frozen between -58°F and +5°F (-50°C to -15°C) for up to 18 months. Use of dry ice may subject to temperatures colder than -58°F (-50°C).

    • May be stored at refrigerator temperature (36°F to 46°F; 2°C to 8°C) for up to 72 hours prior to reconstitution. Discard vaccine if not used within 72 hours at refrigerator temperature.

    • Protect vaccine from light at all times because exposure may inactivate the vaccine viruses.

    • After reconstitution, vaccine should be used immediately. If not used immediately, may store the reconstituted vaccine at room temperature for up to 30 minutes. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.

    • Store diluent separately at room temperature (68°F to 77°F; 20°C to 25°C), or in a refrigerator (36°F to 46°F; 2°C to 8°C).

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Mechanism of Action

    ProQuad has been shown to induce measles-, mumps-, rubella-, and varicella-specific immunity, which is thought to be the mechanism by which it protects against these four childhood diseases.

    Proquad Indications

    Indications

    Measles, mumps, rubella, and varicella immunization.

    Proquad Dosage and Administration

    Adult

    Not recommended.

    Children

    <12 months or ≥13yrs: not established. Each dose is 0.5mL. Give by SC or IM inj. First dose at 12–15 months of age (or anytime through 12yrs of age), second dose at 4–6yrs of age.

    Children

    • Give by SC or IM inj only.

    • A single dose is approximately 0.5mL.

    • First dose is administered at 12 to 15 months of age, but may be administered anytime through 12 years of age. 

    • Second dose is administered at 4 to 6 years of age.

    • Elapse at least 1 month between a dose of a measles-containing vaccine and a dose of ProQuad. Elapse at least 3 months between a dose of varicella-containing vaccine and ProQuad.

    Administration

    • Administer immediately after reconstitution. Reconstitute with the accompanying diluent from its vial and inject into lyophilized vaccine vial. A single dose after reconstitution is ~0.5mL.
    • If not used immediately, reconstituted vaccine may be stored at room temperature, protected from light, for up to 30 minutes. Discard reconstituted vaccine if it is not used within 30 minutes. 
    • The reconstituted vaccine should be a clear pale yellow to light pink liquid.
    • Inject by SC or IM only.

    Proquad Contraindications

    Contraindications

    Gelatin or neomycin hypersensitivity. Immunodeficient or immunosuppressed. Active untreated tuberculosis. Active febrile illness with fever >101.3°F. Pregnancy (or planning to be within the next 3 months).

    Proquad Boxed Warnings

    Not Applicable

    Proquad Warnings/Precautions

    Warnings/Precautions

    History of febrile seizures. Hypersensitivity to eggs. Thrombocytopenia, or history of. Defer vaccination if family history of congenital or hereditary immunodeficiency until immunocompetent. Avoid contact with high-risk individuals susceptible to varicella for 6 weeks after vaccination. Reye syndrome. HIV-infected children. Nursing mothers.

    Warnings/Precautions

    Fever and Febrile Seizures

    • Increased rates of fever and febrile seizures at 5 to 12 days after vaccination with ProQuad (dose 1) in children 12 to 23 months of age who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections vs children vaccinated concomitantly with a first dose of M-M-R II and Varivax.

    • Use caution in individuals with a personal or family history of febrile seizures.

    Hypersensitivity to Eggs

    • Increased risk of immediate-type hypersensitivity reactions in individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (eg, hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion.

    • Evaluate risks/benefits before considering vaccination in these individuals.

    Thrombocytopenia

    • Reports of transient thrombocytopenia within 4 to 6 weeks after vaccination.

    • Carefully evaluate the risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, and rubella vaccine.

    Family History of Immunodeficiency

    • Defer vaccination in individuals with a family history of congenital or hereditary immunodeficiency until the immune status is evaluated and the individual is immunocompetent.

    Use in HIV-Infected Individuals

    • Refer to ACIP recommendations on the use of varicella vaccine in HIV-infected individuals.

    Risk of Vaccine Virus Transmission

    • Vaccine recipients may have a risk of varicella infection, including healthy individuals.

    • High-risk individuals susceptible to varicella include:

      • Immunocompromised individuals.

      • Pregnant women without documented positive history of varicella or laboratory evidence of prior infection.

      • Newborn infants of mothers without documented positive history of varicella or laboratory evidence of prior infection and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.

    • Advise vaccine recipients to avoid contact with high-risk individuals susceptible to varicella for up to 6 weeks after vaccination. If unavoidable, weigh the potential risk of transmission of the varicella vaccine virus against the risk of acquiring and transmitting wild-type varicella virus.

    • Majority of susceptible individuals 7 to 28 days after vaccination have experienced small amounts of the live, attenuated rubella virus excreted from the nose or throat. There have been reports of transmission of the rubella vaccine virus to infants via breast milk.

    Immune Globulins and Transfusions

    • Do not give immune globulins and other blood products concurrently with ProQuad because these products may interfere with vaccine virus replication and decrease the expected immune response. 

    Salicylate Therapy

    • Avoid salicylates (aspirin) or salicylate-containing products in patients 12 months through 12 years of age, for 6 weeks after vaccination due to Reye syndrome with salicylates and wild-type varicella infection.

    Pregnancy Considerations

    Risk Summary

    • ProQuad is contraindicated for use in pregnant women or those who become pregnant within 3 months of administration.

    • The health care provider should be aware of the following:

      • Contracting wild-type measles during pregnancy enhances fetal risk.Increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity have been observed after infection with wild-type measles during pregnancy.

      • Mumps infection during the first trimester may increase the rate of spontaneous abortion.

      • In a 10-year CDC survey of over 700 pregnant women who received rubella vaccine within 3 months before or after conception, none of the newborns had abnormalities compatible with congenital rubella syndrome.

      • Wild-type varicella, if acquired during pregnancy, may lead to congenital varicella syndrome.

    • Insufficient data to inform of vaccine-associated risks with ProQuad administered to pregnant women.

    Nursing Mother Considerations

    Risk Summary

    • Not known whether varicella, measles, or mumps vaccine virus is excreted in human milk.

    • Studies have shown that lactating postpartum women vaccinated with live rubella vaccine may secrete the virus in breast milk and transmit it to breastfed infants.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ProQuad, and any potential adverse effects on the breastfed child from ProQuad or from the underlying maternal condition.

    Pediatric Considerations

    • Do not administer ProQuad to infants younger than 12 months of age or to children 13 years and older. Safety and efficacy of ProQuad have not been established in this patient population.

    Geriatric Considerations

    • Not indicated for use in patients 65 years of age and older. 

    Proquad Pharmacokinetics

    See Literature

    Proquad Interactions

    Interactions

    Immunosuppressants (see Contraindications). Avoid salicylates for 6 weeks after vaccination. Avoid concomitant immune globulin, other blood products; may decrease the immune response (see ACIP recommendations). Separate dosing of measles-containing vaccine by 1 month. If 2nd dose of varicella-containing vaccine needed, separate by 3 months. Concomitant other vaccines: see full labeling. May interfere with tuberculin skin test.

    Interactions

    Immune Globulins and Transfusions

    • Do not give immune globulins and other blood products concurrently with ProQuad because these products may interfere with vaccine virus replication and decrease the expected immune response. 

    • Refer to ACIP for specific recommendations on intervals between administration of antibody containing products and live virus vaccines.

    Salicylates

    • Avoid use of salicylates for 6 weeks after vaccination with ProQuad due to Reye syndrome.

    Corticosteroids and Immunosuppressive Drugs

    • Do not administer to individuals receiving immunosuppressive therapy, including high-dose corticosteroids. Vaccination may lead to disseminated disease and extensive vaccine-associated rash in individuals on immunosuppressive drugs.

    Drug/Laboratory Test Interactions

    • Vaccination may lead to a temporary depression of tuberculin skin sensitivity.

    • If tuberculin skin test is needed, administer the test any time before, simultaneously with, or at least 4 to 6 weeks after ProQuad.

    Use with Other Vaccines

    • Separate dosing of measles-containing vaccine by 1 month. If 2nd dose of ProQuad or varicella-containing vaccine is needed, separate by 3 months. 

    • May administer concomitantly with Haemophilus influenzae type b conjugate and hepatitis B. May administer with pneumococcal 7-valent conjugate vaccine, and/or hepatitis A (inactivated) vaccines.

    Proquad Adverse Reactions

    Adverse Reactions

    Inj site reactions, fever, irritability, rash; others.

    Proquad Clinical Trials

    Clinical Trials

    Formal studies have not been performed to evaluate the clinical efficacy of ProQuad.

    Efficacy of the measles, mumps, rubella, and varicella components of ProQuad was previously established in a series of clinical studies with the monovalent vaccines.

     

    Immunogenicity in Children 12 Months to 6 Years of Age

    • 5 randomized clinical trials evaluated immunogenicity in 5845 healthy children 12 months to 6 years of age with a negative history of measles, mumps, rubella, and varicella.

    • ProQuad administered subcutaneously was found to have similar immunogenicity to its individual component vaccines (M-M-R II and Varivax)

    Immunogenicity in Children 12 to 23 Months of Age After a Single Dose

    • 4 randomized clinical trials evaluated immunogenicity in 5446 healthy children 12 to 23 months of age who received ProQuad subcutaneously, and 2038 children who received M-M-R II and Varivax concomitantly at separate injection sites. The trials included patients with a negative clinical history, no known recent exposure, and no vaccination history for varicella, measles, mumps, and rubella.

    • ProQuad was found to have similar immunogenicity to the concomitant administration of single doses of M-M-R II and Varivax at separate injection sites.

    Immunogenicity in Children 15 to 31 Months of Age After a Second Dose of ProQuad

    • A second dose of ProQuad administered subcutaneously approximately 3 to 9 months after the first dose of ProQuad was evaluated in a subgroup of 5446 children.

    • 2 doses of ProQuad administered at least 3 months apart elicited a positive antibody response to all 4 antigens in greater than 98% of patients.

    • The GMTs after the second dose increased approximately 2-fold for measles, mumps, and rubella, and approximately 41-fold for varicella.

    Immunogenicity in Children 4 to 6 Years of Age Who Received a First Dose of ProQuad After Primary Vaccination With M-M-R II and Varivax

    • 799 healthy children 4 to 6 years of age who previously received M-M-R II and Varivax at least 1 month prior to study entry (at 12 months of age or older) were randomly assigned to receive:

      • ProQuad subcutaneously and placebo (n=399), 

      • M-M-R II and placebo concomitantly at separate injection sites (n=205), or

      • M-M-R II and Varivax concomitantly at separate injection sites (n=195).

    • The first dose of ProQuad administered after primary vaccination with M-M-R II and Varivax elicited a positive antibody response to all 4 antigens in greater than 98% of patients.

    • The GMTs after the first dose of ProQuad were similar to that observed after a second dose of M-M-R II and Varivax. The GMTs for measles, mumps, and rubella after the first dose of ProQuad were similar to that observed after a second dose of M-M-R II and placebo. 

    Immunogenicity Following 2 Doses of ProQuad Administered Intramuscularly or Subcutaneously

    • An open-label clinical trial (NCT00402831) evaluated the immunogenicity of 2 doses of Proquad administered 30 days apart in 405 children 12 through 18 months of age given intramuscularly (IM; n=202) or subcutaneously (SC; n=203).

    • Seroresponse rates to measles, mumps, and varicella viruses after dose 1 were noninferior in the IM group vs the SC group.

    • Seroresponse rate to rubella virus narrowly missed meeting the criterion for noninferiority.

    • Antibody titers above the seroresponse thresholds for measles, mumps, rubella, and varicella viruses after dose 1 was achieved by 100%, 97.4%, 98.4%, and 98.6%, respectively, of children in the IM group and 97.3%, 91.3%, 100%, and 98.5%, respectively, in the SC group.

    Proquad Note

    Notes

    Report adverse events to VAERS by calling (800) 822-7967.

    Proquad Patient Counseling

    Patient Counseling

    • Provide the required vaccine information to the patient, parent, or guardian. 

    • Inform the patient, parent, or guardian of the benefits and risks associated with vaccination. 

    • Inform the patient, parent, or guardian that the vaccine recipient should avoid use of salicylates for 6 weeks after vaccination with ProQuad.

    • Question females of reproductive potential regarding the possibility of pregnancy. Inform postpubertal females to avoid pregnancy for 3 months following vaccination. 

    • Inform the patient, parent, or guardian that vaccination with ProQuad may not offer 100% protection from measles, mumps, and rubella infection. 

    • Instruct patients, parents, or guardians to report any adverse reactions to their health-care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at https://www.vaers.hhs.gov .

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