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measles, mumps, rubella and varicella vaccine, live (ProQuad, MMRV)

 

Classes: Vaccines, Live, Viral

Dosing and uses of ProQuad, MMRV (measles, mumps, rubella and varicella vaccine, live)

 

Adult dosage forms and strengths

Not indicated

 

Pediatric dosage forms and strengths

vaccine

  • lyophilized single dose (supplied with sterile water diluent)

 

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

 

Administration

Refrigerator-stable formulation: Refrigerate at 2-8°C (36-46°F) or colder; the lyophilized vaccine may also be stored in a freezer and subsequently transferred to a refrigerator; however, the lyophilized vaccine should not be refrozen

Keep lyophilized vaccine frozen at -58°F and +5°F (-50°C to -15°C); may be stored at refrigerator temperature (36-46°F, 2-8°C) for up to 72 hr before reconstitution

Administer immediately after reconstitution

Do not freeze reconstituted vaccine, discard if not used within 30 minutes

 

Additional Information

Up-to-date vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.htmL

 

ProQuad, MMRV (measles, mumps, rubella and varicella vaccine, live) adverse (side) 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

 

Warnings

Contraindications

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

Blood dyscrasia, leukemia, lymphoma, malignancy affecting bone marrow/lymphatic system

Immunodeficient patients, family history of immunodeficiency

Active untreated TB

Pregnancy

Fever >101.3°F (38.5°C)

 

Cautions

History of cerebral injury, individual/family history of convulsions, any other condition where stress due to fever needs to be avoided, hypersensitivity to eggs

Hypersensitivity to neomycin-may cause contact dermatitis

No information of safety/efficacy if given after exposure

Febrile seizures

  • Early findings from an ongoing CDC study show that children who get an MMRV vaccine may be twice as likely to have a febrile seizure 7-10 days after getting the shot than children who get MMR and varicella vaccines (2 shots) at the same health care visit
  • During the 7-10 days after vaccination, about one additional febrile seizure would be expected to occur among every 2,000 children vaccinated with MMRV vaccine, compared with children vaccinated with MMR and varicella administered at the same visit

 

Pregnancy and lactation

Pregnancy category: C (contraindicated)

Lactation: Contraindicated

 

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.

 

Pharmacology of ProQuad, MMRV (measles, mumps, rubella and varicella vaccine, live)

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