Vaccine Information: ProQuad

PROQUAD- measles virus strain enders’ attenuated edmonston live antigen, mumps virus strain b level jeryl lynn live antigen, rubella virus strain wistar ra 27/3 live antigen and varicella-zoster virus strain oka/merck live antigen injection, powder, lyophilized, for suspension
Merck Sharp & Dohme Corp.

1 INDICATIONS AND USAGE

ProQuad® is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedule

FOR SUBCUTANEOUS ADMINISTRATION ONLY

Each 0.5-mL dose of ProQuad is administered subcutaneously.

The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R® II (measles, mumps, and rubella virus vaccine live) and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

2.2 Preparation for Administration

CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents, and other anti-viral substances for reconstitution and injection of ProQuad.

Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives or other anti-viral substances.

Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.

Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe, inject the entire volume, and discard vial.

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. IF NOT USED IMMEDIATELY, THE 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.

2.3 Method of Administration

Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

Use With Other Vaccines

Use different injection sites to administer each vaccine if other vaccines are administered concomitantly. [See Drug Interactions (7.5).]

3 DOSAGE FORMS AND STRENGTHS

ProQuad is a suspension for injection supplied as a 0.5-mL single dose vial of lyophilized vaccine to be reconstituted using the sterile diluent supplied [see How Supplied/Storage and Handling (16)].

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Do not administer ProQuad to individuals with a history of anaphylactic reactions to neomycin. If vaccination with ProQuad is medically necessary for such individuals, they are advised to consult an allergist or immunologist and should receive ProQuad only in settings where anaphylactic reactions can be appropriately managed.

Do not administer ProQuad to individuals with a history of hypersensitivity to gelatin or any other component of the vaccine or following previous vaccination with ProQuad, VARIVAX® (varicella virus vaccine live), or any measles-, mumps-, or rubella-containing vaccine [see Description (11) and Warnings and Precautions (5) for exceptions].

4.2 Immunosuppression

Do not administer ProQuad to individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; or to individuals on immunosuppressive therapy (including high-dose systemic corticosteroids) [see Drug Interactions (7.3)]. 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. ProQuad may be used by individuals who are receiving topical corticosteroids or low-dose corticosteroids, as are commonly used for asthma prophylaxis or in patients who are receiving corticosteroids as replacement therapy, e.g. , for Addison’s disease.

Do not administer ProQuad to individuals with primary and acquired immunodeficiency states, including AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. Measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In addition, disseminated varicella vaccine virus infection has been reported in children with underlying immunodeficiency disorders who were inadvertently vaccinated with a varicella-containing vaccine {1}.

Do not administer ProQuad to individuals with a family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.

4.3 Concurrent Illness

Do not administer ProQuad to individuals with active untreated tuberculosis or to individuals with an active febrile illness with fever >101.3°F (>38.5°C).

4.4 Pregnancy

Do not administer ProQuad to individuals who are pregnant because the effects of the vaccine on fetal development are unknown. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for three months following administration of ProQuad [see Use in Specific Populations (8.1) and Patient Counseling Information (17)].

5 WARNINGS AND PRECAUTIONS

5.1 Fever and Febrile Seizures

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with dose 1 of both M-M-R II and VARIVAX administered separately [see Adverse Reactions (6.3)].

5.2 History of Cerebral Injury or Seizures

Exercise caution when administering ProQuad 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. Healthcare providers should be alert to the temperature elevations that may occur following vaccination.

5.3 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. Carefully evaluate the potential risk-to-benefit ratio 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 Contraindications (4.1)] {2}.

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 {2}.

5.4 Contact 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.

5.5 Thrombocytopenia

Carefully evaluate the potential risk-to-benefit ratio before considering vaccination with ProQuad in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, rubella, and/or varicella vaccine. No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad. Cases of thrombocytopenia have been reported after primary vaccination with measles vaccine; measles, mumps, and rubella vaccine; after varicella vaccination; and following re-vaccination with measles vaccine or M-M-R II [see Adverse Reactions (6.2)].

5.6 Use for Post-Exposure Prophylaxis

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

5.7 Use in HIV-Infected Children

The safety and efficacy of ProQuad for use in children known to be infected with human immunodeficiency viruses have not been established.

5.8 Risk of Vaccine Virus Transmission

Post-licensing experience with VARIVAX suggests that transmission of varicella vaccine virus may occur between healthy vaccine recipients (who develop or do not 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 and all newborn infants born at <28 weeks gestation regardless of maternal varicella immunity.

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.

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 Use in Specific Populations (8.2)].

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.

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