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|Measles, Mumps, Rubella, and Varicella Virus Vaccine, Live

Measles, Mumps, Rubella, and Varicella Virus Vaccine, Live

Trade Names:
ProQuad
- Powder for injection, lyophilized mixture of 4 viruses: at least 3 log ₁₀ measles TCID ₅₀ (50% tissue culture infectious doses), 4.3 log ₁₀ mumps TCID ₅₀ , 3 log ₁₀ rubella TCID ₅₀ , and at least 3.99 log ₁₀ varicella plaque-forming units (PFU) per 0.5 mL dose

Mechanism of Action

Pharmacology

Produces active immunity to measles, mumps, rubella, and varicella viruses by inducing antibody production.

Indications and Usage

Simultaneous vaccination against measles, mumps, rubella, and varicella in children 12 mo to 12 yr of age; may be used in children 12 mo to 12 yr of age if a second dose of measles, mumps, and rubella vaccine is to be administered.

Contraindications

Individuals with a history of anaphylactic reactions to neomycin; individuals with a history of hypersensitivity to gelatin or any component of the vaccine; individuals with blood dyscrasias leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; individuals on immunosuppressive therapy (including high-dose systemic corticosteroids); individuals with primary and acquired immunodeficiency states (including AIDS or other clinical manifestation of infection with HIV), cellular immune deficiencies, and hypogammaglobulinemic and dysgammaglobulinemic states; individuals with family history of congenital or hereditary immunodeficiency (unless immune competence of the potential vaccine recipient has been demonstrated); individuals with active, untreated tuberculosis; individuals with an active febrile illness with fever over 101.3°F; individuals who are pregnant.

Dosage and Administration

Subcutaneous Single 0.5 mL dose. Allow at least 1 mo from previous dose of measles-containing vaccine. If second dose of a varicella-containing vaccine is required, at least 3 mo should elapse between doses.

General Advice

• For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
• Have epinephrine injection and other appropriate agents and equipment immediately available in case an acute anaphylactic reaction occurs.
• Reconstitute vaccine using only supplied diluent. Withdraw entire amount of supplied diluent into syringe; inject into vial containing powder. Gently agitate to dissolve completely.
• Use only sterile syringes free of preservatives, antiseptics, detergents, or other antiviral substances.
• Administer reconstituted vaccine immediately after reconstitution. Discard reconstituted vaccine if not used within 30 min.
• Administer subcutaneous in outer aspect of deltoid region of upper arm or in the higher anterolateral area of the thigh.
• Reconstituted solution should be clear and pale yellow to light pink in color. Do not use if discoloration, cloudiness, or particulate matter is noted.
• May administer vaccine in conjunction with Haemophilus influenzae type b conjugate and hepatitis B vaccines, using separate syringes and different sites for administration.
• Always record manufacturer"s name, vaccine lot number, date of administration, and name and title of person administering vaccine in patient"s permanent medical record file.

Storage/Stability

Store powder for injection continuously in a frost-free freezer (−15° or colder) for up to 18 mo. Protect from light. Do not store powder for injection in refrigerator; discard any vaccine inadvertently stored in refrigerator. Do not freeze reconstituted vaccine. Store diluent separately at controlled room temperature (68° to 77°F) or in refrigerator (36° to 46°F).

Drug Interactions

Do not administer vaccine to individuals receiving immunosuppressive doses of corticosteroids or other immunosuppressive agents.

May interfere with expected immune response. Defer vaccination for at least 3 mo following blood or plasma transfusions or administration of immune globulin.

Risk of Reye syndrome may be increased. Avoid use of salicylates for 6 wk after vaccination.

Laboratory Test Interactions

May result in a temporary depression of tuberculin skin sensitivity. If tuberculin test is to be done, administer before, simultaneously with, or at least 4 to 6 wk after measles, mumps, rubella, and varicella virus vaccine. At least 1 mo should elapse between a dose of measles-containing vaccine and administration of measles, mumps, rubella, and varicella virus vaccine. If a second dose of varicella-containing vaccine is necessary, at least 3 mo should elapse between administration of the 2 doses.

Adverse Reactions

CNS

Irritability (7%); aseptic meningitis, encephalitis, encephalopathy, subacute sclerosing panencephalitis (postmarketing).

Dermatologic

Measles-like rash (3%); rash, varicella-like rash (2%); viral exanthema (1%).

GI

Diarrhea (1%).

Local

Pain, soreness, tenderness (22%); erythema (14%); swelling (8%); ecchymosis, rash (2%).

Musculoskeletal

Arthralgia, arthritis (postmarketing).

Respiratory

Upper respiratory infection (1%).

Miscellaneous

Fever (22%); death (causal relationship not established [postmarketing]).

Precautions

Pregnancy

Category C . Do not administer to pregnant women. If postpubertal women are vaccinated, pregnancy should be avoided for 3 mo.

Lactation

Undetermined (measles and mumps vaccine viruses); secreted in breast milk and transmitted to breastfed infants (rubella virus); undetected in breast milk (varicella). Do not administer to breastfeeding women.

Children

Safety and efficacy have not been established in children younger than 12 mo of age.

Special Risk Patients

Use with caution in patients with history of cerebral injury, individual or family history of convulsions, or any other condition in which stress caused by fever should be avoided.

Creutzfeld-Jakob Disease (CJD)

Contains albumin; theoretical risk of transmission of CJD and viral diseases.

HIV

Safety and efficacy have not been established for use in HIV-infected patients.

Hypersensitivity to eggs

Patients with a history of anaphylactic or other immediate hypersensitivity reactions (eg, difficulty breathing, hives, hypotension, swelling of mouth or throat) subsequent to egg ingestion may be at increased risk of immediate-type hypersensitivity reactions after receiving the vaccine. Vaccinate these patients with extreme caution; have adequate treatment for reactions readily available. Patients with allergies to chickens or feathers are not at increased risk of reaction to vaccine.

Hypersensitivity to neomycin

Neomycin allergy presenting as a contact dermatitis is not a contraindication for vaccination.

Immunosuppressive therapy

Vaccination with live attenuated vaccine can result in a more extensive, vaccine-associated rash or disseminated disease in patients on immunosuppressive therapy.

Thrombocytopenia

Patients with thrombocytopenia may develop more severe thrombocytopenia; patients who experienced thrombocytopenia following the first dose of live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.

Transmission to others

Transmission of varicella vaccine virus may occur rarely between healthy vaccine recipients who develop varicella-like rash and contacts susceptible to varicella, as well as high-risk patients susceptible to varicella (eg, immunocompromised; pregnant women or newborn infants of mothers without documented positive history of varicella or lab evidence of prior infection). Vaccine recipients should attempt to avoid close association with high-risk individuals susceptible to varicella for up to 6 wk following vaccination.

Overdosage

Symptoms

None documented.

Patient Information

• Explain name, action, potential benefits, and potential side effects of vaccine.
• Provide and review the Vaccine Information Statements prior to immunization.
• Provide parent or guardian with immunization history record.
• Advise parent or guardian of child with history of seizures, or family member with seizure disorder, that controlling fever after vaccination is very important. Advise parent or guardian to use an aspirin-free pain reliever (eg, acetaminophen, ibuprofen) to control/treat fever.
• Caution patient, family, or caregiver to avoid use of salicylates for 6 wk following vaccination.
• Advise patient, family, or caregiver that vaccine may cause a varicella-like (chicken-pox) rash and, if it occurs, to avoid close association with high-risk individuals susceptible to varicella for up to 6 wk following vaccination.
• Advise parent or guardian that the following problems occur frequently shortly after vaccination but are generally mild: fever; irritability; measles-like or chicken-pox-like rashes; redness, soreness, swelling, or tenderness at injection site.
• Advise parent or guardian to use nonaspirin-containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, or pain or discomfort at injection site.
• If vaccine recipient is a postpubertal woman, caution patient to avoid becoming pregnant for 3 mo following vaccination.