measles, mumps, rubella and varicella vaccine, live (Rx)

Brand and Other Names:ProQuad, MMRV
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Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

measles virus/mumps virus/rubella virus/varicella virus

injection, lyophilized powder for reconstitution

  • ≥1000 TCID50/≥13,000 TCID50/≥1000 TCID50/≥1,999 PFU

Measles, Mumps, Rubella, & Varicella Vaccination

Routine vaccination (2 doses): First dose of 0.5 mL SC between age 12-15 months; administer second dose between age 4-6 yr

Allow at least 3 months between a dose of varicella-containing vaccine and ProQuad

Allow at least 4 wk between other measles-containing vaccines and ProQuad

Current vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.html

Additional dose during mumps outbreak

  • CDC ACIP recommendations MMWR January 12, 2018:67(1);33-38
  • Increased risk for acquiring mumps are individuals who are more likely to have prolonged or intense exposure to droplets or saliva from a person infected with mumps, (eg, close contact or sharing of drinks or utensils)
  • During an outbreak, persons identified as being at increased risk who have received ≤2 doses of mumps virus-containing vaccine or have unknown vaccination status should receive 1 additional dose
  • MMRV vaccine, may also be used when a third dose of mumps vaccine is indicated among children aged ≤12 yr
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Interactions

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            Adverse Effects

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            >10%

            Fever >102F (21.5%)

            Inj site pain/tenderness/soreness (22%)

            Inj site erythema (14%)

            1-10%

            Rash (9%, incl inj site, measles-like & varicella-like)

            1nj site swelling (8.4%)

            Irritability (6.7%)

            Postmarketing Reports

            Infections and infestations: Atypical measles, candidiasis, cellulitis, herpes zoster, infection, influenza, measles, orchitis, parotitis, respiratory infection, skin infection, varicella (vaccine strain)

            Blood and the lymphatic system disorders: Aplastic anemia, lymphadenitis, regional lymphadenopathy, thrombocytopenia

            Immune system disorders: Anaphylactoid reaction, anaphylaxis and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, anaphylaxis in individuals with or without an allergic history

            Psychiatric disorders: Agitation, apathy, nervousness

            Nervous system disorders: Acute disseminated encephalomyelitis (ADEM), afebrile convulsions or seizures, aseptic meningitis (see below), ataxia, Bell palsy, cerebrovascular accident, convulsion, dizziness, dream abnormality, encephalitis, encephalopathy, febrile seizure, Guillain-Barré syndrome, headache, hypersomnia, measles inclusion body encephalitis, ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis, syncope, transverse myelitis, tremor

            Eye disorders: Edema of the eyelid, irritation, necrotizing retinitis (reported only in immunocompromised individuals), optic neuritis, retinitis, retrobulbar neuritis

            Ear and labyrinth disorders: Ear pain, nerve deafness

            Vascular disorders: Extravasation

            Respiratory, thoracic and mediastinal disorders: Bronchial spasm, bronchitis, epistaxis, pneumonitis, pneumonia, pulmonary congestion, rhinitis, sinusitis, sneezing, sore throat, wheezing

            Gastrointestinal disorders: Abdominal pain, flatulence, hematochezia, mouth ulcer

            Skin and subcutaneous tissue disorders: Erythema multiforme, Henoch-SchÖnlein purpura, herpes

            Musculoskeletal, connective tissue and bone disorders: Arthritis and/or arthralgia (usually transient and rarely chronic, see below); musculoskeletal pain; myalgia; pain of the hip, leg, or neck; swelling

            Reproductive system and breast disorders: Epididymitis

            General disorders and administration site conditions: Injection-site complaints (burning and/or stinging of short duration, eczema, edema/swelling, hive-like rash, discoloration, hematoma, induration, lump, vesicles, wheal and flare), inflammation, lip abnormality, papillitis, roughness/dryness, stiffness, trauma, varicella-like rash, venipuncture site hemorrhage, warm sensation, warm to touch

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            Warnings

            Contraindications

            Pregnancy (see Pregnancy and Lactation)

            Hypersensitivity

            • History of anaphylactic reaction to neomycin (may consult allergist/immunologist if absolutely necessary, give in setting where anaphylactic reaction can be immediately controlled)
            • Hypersensitivity to gelatin or any other component

            Immunosuppression

            • Individuals with blood dyscrasias, leukemia, lymphomas of any type, or malignancy affecting bone marrow/lymphatic system
            • Primary and acquired immunodeficiency states including AIDS, cellular immune deficiencies, hypogammaglobulinemic and dysgammaglobulinemic states, or family history of congenital or hereditary immunodeficiency
            • Individuals taking immunosuppressive drugs; may be used with topical corticosteroids or low-dose corticosteroids (as commonly used for asthma prophylaxis) or in patients who are receiving corticosteroids as replacement therapy (eg, Addison disease)

            Concurrent illness

            • Active untreated TB
            • Fever >101.3°F (38.5°C)

            Cautions

            Caution when administering MMRV 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

            History of anaphylactic or other immediate hypersensitivity reactions (eg, hives, laryngeal edema, 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

            Neomycin allergy most often manifests as contact dermatitis, which is not a contraindication to receiving the vaccine

            Caution in children with thrombocytopenia, of those who experienced thrombocytopenia after vaccination

            Safety and efficacy for postexposure prophylaxis have not been established

            Safety and efficacy in HIV-infected children have not been established

            Postmarketing reports suggest transmission of vaccine virus may occur to high risk individuals (eg, immunocompromised, pregnant women without positive varicella history or vaccination, or newborn infants of mothers without positive varicella history)

            Contains albumin; theoretical risk for transmission Creutzfeldt-Jacob disease

            Febrile seizures

            • Administration of MMRV (dose 1) to children aged 12-23 months 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 5-12 days after vaccination when compared with children vaccinated with dose 1 of both MMR and varicella vaccine administered separately

            Drug interactions overview

            • Immune globulins and transfusion
              • Immune globulins (IG) coadministered with MMRV contain antibodies that may interfere with vaccine virus replication and decrease the expected immune response
              • Defer vaccination; appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (eg, 5 months for varicella zoster immune globulin)
              • Refer to prescribing information for specific recommendations
            • Salicylates
              • Reye syndrome reported following salicylate administration during wild-type varicella infection
              • Avoid salicylates for 6 weeks after vaccination
            • Corticosteroids and immunosuppressive drugs
              • Do not administer to individuals receiving immunosuppressive doses of corticosteroids or other immunosuppressive drugs
              • Can result in a more extensive vaccine-associated rash or disseminated disease in individuals on immunosuppressive drugs (see Contraindications)
            • Use with other vaccines
              • At least 1 month should elapse between a dose of a measles-containing vaccine (eg, MMR) and a dose of MMRV, and at least 3 months should elapse between administration of 2 doses of MMRV or varicella-containing vaccines
            • Lab tests
              • MMR vaccine 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 MMRV
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated during pregnancy; avoid pregnancy for 3 months following vaccination

            In a 10-year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome

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

            Although mumps vaccine virus has been shown to infect the placenta and fetus, there is no evidence that it causes congenital malformations in humans

            Reports have indicated that contracting wild-type measles during pregnancy enhances fetal risk; increased rates of spontaneous abortion, stillbirth, congenital defects and prematurity have been observed subsequent to infection with wild-type measles during pregnancy

            There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy; however, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse fetal effects

            Lactation

            Unknown if measles or mumps vaccine is secreted in human milk

            The prescribing information describes studies that have shown lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breastfed infants

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Vaccine containes live, attenuated viruses that stimulate active immunity

            Pharmacokinetics

            Duration: At least 1 year; not studied for longer periods

            These products convey active immunity via stimulation of production of endogenously produced antibodies

            Onset of protection from disease is relatively slow, but duration is long lasting (years)

            Pharmacogenomics

            HLA-B7, HLA-B51, HLA-DRB1*13, and HLADQA1*01 is associated with a measles vaccine response

            Homozygosity at HLA-B, HLA-DR, and HLA-DQA1 has been associated with a measles vaccine nonresponse

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            Administration

            SC Preparation

            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 antiviral substances

            Inject the entire content of the syringe into the vial containing the powder

            Gently agitate to dissolve completely

            Visually inspect the resulting solution; when reconstituted, the solution is a clear pale yellow to light pink liquid

            Administer immediately after reconstitution; if not used immediately, may be stored at room temperature, protected from light, for up to 30 min

            Discard if not used within 30 minutes

            SC Administration

            Withdraw the entire amount of the reconstituted vaccine from the vial into a syringe and inject the entire volume SC

            Administer SC in the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh

            Storage

            Unopened lyophilized powder

            • Keep unopened lyophilized vaccine frozen at -58°F to +5°F (-50°C to -15°C)
            • May be stored refrigerated at 36-46°F (2-8°C) for up to 72 hr before reconstitution
            • Discard if not reconstituted and administered within 72 hr of refrigeration
            • Protect from light

            Reconstituted vaccine

            • Administer immediately after reconstitution
            • Do not freeze reconstituted vaccine
            • Discard if not used within 30 minutes
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.