Measles Mumps Rubella Varicella Vaccine Live (Proquad)
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Measles Mumps Rubella Varicella Vaccine Live (Proquad)

ProQuad®
[Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live]

DRUG DESCRIPTION

ProQuad (measles mumps rubella varicella vaccine live) * is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad (measles mumps rubella varicella vaccine live) is a sterile lyophilized preparation of (1) the components of M-M-R*ll (Measles, Mumps and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps vims propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells. The cells, virus pools, bovine serum, and human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents.

ProQuad (measles mumps rubella varicella vaccine live) , when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5-mL dose contains not less than 3.00 log10 TCID50 (50% tissue culture infectious dose) of measles virus; 4.30 log10 TCID50 of mumps virus; 3.00 log10 TCID50 of rubella virus; and a minimum of 3.99 log10 PFU (plaque-forming units) of Oka/Merck varicella virus.

Each 0.5-mL dose of the vaccine contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 meg of potassium phosphate monobasic, 60 meg of potassium chloride; 36 meg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; < 16 meg of neomycin, bovine calf serum (0.5 meg), and other buffer and media ingredients. The product contains no preservative.

What are the possible side effects of this vaccine (ProQuad)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is...

Read All Potential Side Effects and See Pictures of Proquad »

What are the precautions when taking measles mumps rubella varicella vaccine live (Proquad)?

Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

There is a small risk...

Read All Potential Precautions of Proquad »

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ProQuad (measles mumps rubella varicella vaccine live) is indicated for simultaneous vaccination against measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

ProQuad (measles mumps rubella varicella vaccine live) may be used in children 12 months through 12 years of age if a second dose of measles, mumps and rubella vaccine is to be administered.

DOSAGE AND ADMINISTRATION

Dosage

When reconstituted, each vial of ProQuad (measles mumps rubella varicella vaccine live) contains a single 0.5-mL dose. Individuals 12 months through 12 years of age should receive a single 0.5-mL dose of ProQuad (measles mumps rubella varicella vaccine live) administered subcutaneously. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R II, and a dose of ProQuad (measles mumps rubella varicella vaccine live) . If for any reason a second dose of varicella-containing vaccine is required, at least 3 months should elapse between administration of the 2 doses.

Preparation

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 (measles mumps rubella varicella vaccine live) .

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.

Visually inspect the vaccine before and after reconstitution for particulate matter and discoloration prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad (measles mumps rubella varicella vaccine live) , 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 and inject the entire volume.

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

Method of Administration

FOR SUBCUTANEOUS ADMINISTRATION

DO NOT INJECT INTRAVASCULARLY

Use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.

The vaccine is to be injected subcutaneously in the outer aspect of the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Properly dispose of all needles and syringes. Do not recap needles.

Use With Other Vaccines

If another vaccine is administered concomitantly, a different injection site should be used.

See PRECAUTIONS: DRUG INTERACTIONS, Use With Other Vaccines.

HOW SUPPLIED

No. 4999-ProQuad (measles mumps rubella varicella vaccine live) is supplied as follows: (1) a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4999-00 (package A); and (2) a separate package of 10 vials of sterile water diluent (package B).

Storage

During shipment, to ensure that there is no loss of potency, the vaccine must be maintained at a temperature of 5°F (-15°C) or colder.

Before reconstitution, store the lyophilized vaccine continuously in a freezer (e.g., chest, frost- free) for up to 18 months, at an average temperature of 5°F (-15°C) or colder. Any freezer that reliably maintains an average temperature of 5°F or colder and has a separate sealed freezer door is acceptable for storing ProQuad (measles mumps rubella varicella vaccine live) .

ProQuad (measles mumps rubella varicella vaccine live) may be stored at refrigerator temperature (36 to 46°F, 2 to 8°C) for up to 72 hours prior to reconstitution. Vaccine stored at 36 to 46°F which is not used within 72 hours of removal from 5°F storage should be discarded.

For information regarding stability under conditions other than those recommended, call 1-800- MERCK-90.

Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.

DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

DO NOT FREEZE RECONSTITUTED VACCINE.

Diluent should be stored separately at room temperature (68 to 77°F, 20 to 25°C), or in a refrigerator (36 to 46°F, 2 to 8°C).

Dist. by: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Issued October 2007. FDA Rev date: 10/23/2007

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Children 12 to 23 Months of Age

ProQuad (measles mumps rubella varicella vaccine live) was administered to 4497 children 12 to 23 months of age in clinical trials without concomitant administration with other vaccines. The safety of ProQuad (measles mumps rubella varicella vaccine live) was compared with the safety of M-M-R II and VARIVAX given concomitantly at separate injection sites. The safety profile for ProQuad (measles mumps rubella varicella vaccine live) was similar to the component vaccines. Children in these studies were monitored for up to 42 days post- vaccination. The only systemic vaccine-related adverse experiences that were reported at a significantly greater rate in individuals who received ProQuad (measles mumps rubella varicella vaccine live) than in individuals who received M-M-R II and VARIVAX concomitantly at separate injection sites were fever ( ≥ 102°F [ ≥ 38.9°C] oral equivalent or abnormal) (21.5% versus 14.9%, respectively), and measles-like rash (3.0% versus 2.1%, respectively). Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration, and resolved with no long-term sequelae. Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad (measles mumps rubella varicella vaccine live) than in individuals who received M-M-R II and VARIVAX concomitantly at separate injection sites (22.0% versus 26.7%, respectively). The only vaccine-related injection-site adverse experience that was more frequent among recipients of ProQuad (measles mumps rubella varicella vaccine live) than recipients of M-M-R II and VARIVAX was rash at the injection site (2.3% versus 1.5%, respectively). Table 1 summarizes the frequencies of injection-site and systemic adverse experiences that were reported as vaccine related by the investigator among > 1% of children in these clinical trials.

Table 1: Vaccine-Related Injection-Site and Systemic Adverse Experiences Reported in 21 % of Children Who Received 1 Dose of ProQuad (measles mumps rubella varicella vaccine live) or M-M-R II and VARIVAX at 12 to 23 Months of Age (0-42 Days Postvaccination)

Adverse Experiences ProQuad (measles mumps rubella varicella vaccine live)
(N = 4497)
%
M-M-R II and VARIVAX
(N = 2038)
%
Injection Site
  Pain/tenderness/soreness 22.0 26.7
  Erythema 14.4 15.8
  Swelling 8.4 9.8
  Ecchymosis 1.5 2.3
  Rash 2.3 1.5
Systemic
  Fever ≥ 102°F ( ≥ 38.9°C)§ 21.5 14.9
  Irritability 6.7 6.7
  Measles-like rash 3.0 2.1
  Varicella-like rash 2.1 2.2
  Rash (not otherwise specified) 1.6 1.4
  Upper respiratory infection 1.3 1.1
  Viral exanthema 1.2 1.1
  Diarrhea 1.2 1.3
Injection-site adverse experiences for M-M-R II and VARIVAX are based on occurrence with either of the vaccines administered.
Designates a solicited adverse experience. Injection-site adverse experiences were solicited only from Days 0-4 postvaccination.
§ Temperature reported as oral equivalent or abnormal.

The following additional vaccine-related clinical adverse experiences (incidence ≥ 0.2% but < 1%) were observed in individuals following a single dose of ProQuad (measles mumps rubella varicella vaccine live) . Solicited adverse experiences are designated with the symbol ().

Infections and infestations: otitis, otitis media, pharyngitis, viral infection.

Metabolism and nutrition disorders: anorexia.

Psychiatric disorders: crying, insomnia, sleep disorder.

Nervous system disorders: somnolence.

Respiratory, thoracic, and mediastinal disorders: cough, nasal congestion, respiratory congestion, rhinorrhea.

Gastrointestinal disorders: vomiting.

Skin and subcutaneous tissue disorders: miliaria rubra, rubella-like rash*.

General disorders and administration site conditions: malaise.

Post-marketing reports

The following additional adverse events have been reported with ProQuad (measles mumps rubella varicella vaccine live) in post-marketing experience.

Infections and infestations: herpes zoster, varicella.

Immune system disorders: anaphylactic reaction.

Nervous system disorders: ataxia, convulsion, febrile seizure.

Skin and subcutaneous tissue disorders: pruritus.

Adverse Experiences after vaccination with M-M-RII or VARIVAX

Other adverse experiences have been reported in clinical studies and with marketed use of either M-M-R II, the monovalent component vaccines of M-M-R II, or VARIVAX. These adverse effects are listed below without regard to causality or frequency.

Infections and infestations

Atypical measles, candidiasis, cellulitis, infection, influenza, measles, orchitis, parotitis, respiratory infection, skin infection.

Blood and the lymphatic system disorders

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

Afebrile convulsions or seizures, aseptic meningitis (see below), Bell's palsy, cerebrovascular accident, dizziness, dream abnormality, encephalitis (see below), encephalopathy (see below), Guillain- Barre syndrome, headache, hypersomnia, measles inclusion body encephalitis (see CONTRAINDICATIONS), ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis (see below), syncope, transverse myelitis, tremor.

Eye disorders

Edema of the eyelid, irritation, 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 (see CONTRAINDICATIONS), 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-Schonlein purpura, herpes simplex, impetigo, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, sunburn.

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.

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.

Post-marketing surveillance

The discussion that follows describes adverse reactions which have been identified post-approval for the monovalent components of ProQuad (measles mumps rubella varicella vaccine live) . Because these reactions are described in the literature or reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship.

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals. Death as a direct consequence of disseminated measles vaccine virus infection has been reported in severely immunocompromised individuals in whom a measles-containing vaccine is contraindicated and who were inadvertently vaccinated. However, there were no deaths or permanent sequelae reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982 to 1993.16

Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of the combination of measles, mumps, and rubella vaccine contained in M-M-R II. Post-marketing surveillance of the more than 400 million doses that have been distributed worldwide (1978 to 2003) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported. In no case has it been shown conclusively that reactions were actually caused by the vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with wild-type measles (1 per 2000 reported cases).

Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and gender, being greatest in adult females and least in prepubertal children. Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 26%), and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women. In women 35 to 45 years old these reactions are generally well tolerated and rarely interfere with normal activities.

Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.

There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. Based on estimated measles vaccine distribution in the United States (US), the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with infection with wild-type measles, 6 to 22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.

Cases of aseptic meningitis have been reported to VAERS following measles, mumps, and rubella vaccination. Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.

The reported rate of zoster in recipients of VARIVAX appears not to exceed that previously determined in a population-based study of healthy children who had experienced wild-type varicella.17 In clinical trials, 8 cases of herpes zoster were reported in 9454 vaccinated individuals 12 months to 12 years of age during 42,556 person-years of follow-up. This resulted in a calculated incidence of at least 18.8 cases per 100,000 person-years. All 8 cases reported after VARIVAX were mild and no sequelae were reported. The long-term effect of VARIVAX on the incidence of herpes zoster is unknown at present.

Read the Proquad (measles mumps rubella varicella vaccine live) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Immune Globulins and Transfusions

Immune globulins administered concomitantly with ProQuad (measles mumps rubella varicella vaccine live) may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).

The appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g., 5 months for Varicella Zoster Immune Globulin rVZIG]).11 Following administration of ProQuad (measles mumps rubella varicella vaccine live) , any immune globulin (IG) including VZIG should not be given for 1 month thereafter unless its use outweighs the benefits of vaccination.11

Salicylates

Reye's syndrome has been reported following the use of salicylates during wild-type varicella infection. Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (measles mumps rubella varicella vaccine live) .

Corticosteroids and Immunosuppressive Drugs

ProQuad (measles mumps rubella varicella vaccine live) may be used in individuals who are receiving topical corticosteroids or low-dose corticosteroids for asthma prophylaxis or replacement therapy, e.g., for Addison's disease. ProQuad (measles mumps rubella varicella vaccine live) should not be given to individuals receiving immunosuppressive doses of corticosteroids or other immunosuppressive drugs.

Drug/Laboratory Test Interactions

Live attenuated measles, mumps, and rubella virus vaccines 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 ProQuad (measles mumps rubella varicella vaccine live) .

Use with Other Vaccines

At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R II, and a dose of ProQuad (measles mumps rubella varicella vaccine live) . If for any reason a second dose of varicella-containing vaccine is required, at least 3 months should elapse between administration of the 2 doses.

ProQuad (measles mumps rubella varicella vaccine live) may be administered concomitantly with Haemophilus influenzae type b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine.

There are no data regarding the administration of ProQuad (measles mumps rubella varicella vaccine live) with inactivated poliovirus vaccine or pneumococcal conjugate vaccine.

There are insufficient data to support concomitant vaccination with diphtheria, tetanus and acellular pertussis vaccine (see Clinical Studies, Studies with Other Vaccines).

Children under treatment for tuberculosis have not experienced exacerbation of the disease when vaccinated with live measles virus vaccine; no studies have been reported to date of the effect of measles virus vaccines on children with untreated tuberculosis.

REFERENCES

16. Peltola H, et al. The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two-dose vaccination program. NEngl J Med. 331(21):1397-1402, 1994.

17. Guess HA, et al. Population-based studies of varicella complications. Pediatrics. 78(4 Pt 2):723-727, 1986.

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Caution should be exercised in administering ProQuad (measles mumps rubella varicella vaccine live) 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. The physician should be alert to the temperature elevations that may occur following vaccination (see ADVERSE REACTIONS). 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.

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. The potential risk-to-benefit ratio should be carefully evaluated 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 PRECAUTIONS).11

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.11

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.

Thrombocytopenia

No clinical data are available regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad (measles mumps rubella varicella vaccine live) . Cases of thrombocytopenia have been reported after use of measles vaccine, measles, mumps and rubella vaccine and after varicella vaccination. Post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses. Serologic testing for antibody to measles, mumps or rubella should be considered in order to determine if additional doses of vaccine are needed. The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad (measles mumps rubella varicella vaccine live) in such cases.

Theoretical Risk of Transmission of Creutzfeldt-Jakob Disease

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. Although there is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), no cases of transmission of CJD or viral disease have ever been identified that were associated with the use of albumin.

PRECAUTIONS

General

Prior to administering the vaccine, obtain the prospective vaccinee's vaccination history and determine whether the individual had any previous reactions to any vaccine including ProQuad (measles mumps rubella varicella vaccine live) , VARIVAX or any measles-, mumps- or rubella-containing vaccines.

Adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic reaction occur.

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 doses of corticosteroids.

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

The safety and efficacy of ProQuad (measles mumps rubella varicella vaccine live) for use in children and young adults who are known to be infected with human immunodeficiency viruses have not been established (see CONTRAINDICATIONS).

Transmission

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 PRECAUTIONS, Nursing Mothers).

There are no reports of transmission of the more attenuated Ender's Edmonston strain of measles virus or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.

Post-licensing experience with VARIVAX suggests that transmission of varicella vaccine virus may occur rarely between healthy vaccine recipients who 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.

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.

Carcinogenesis, Mutagenesis, Teratogenicity, Impairment of Fertility

ProQuad (measles mumps rubella varicella vaccine live) has not been evaluated for its carcinogenic, mutagenic or teratogenic potential, or its potential to impair fertility.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with ProQuad (measles mumps rubella varicella vaccine live) .

It is also not known whether ProQuad (measles mumps rubella varicella vaccine live) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, ProQuad (measles mumps rubella varicella vaccine live) should not be administered to pregnant females. If vaccination of post-pubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination (see CONTRAINDICATIONS).

In counseling women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware of the following: (1) 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 natural 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; (2) 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;12 (3) 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 RA27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome;13 and (4) Wild-type varicella can sometimes cause congenital varicella infection.

Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to varicella-containing vaccine (Oka/Merck). In the first 9 years of the Pregnancy Registry for varicella vaccine (Oka/Merck), of 129 seronegative women and 423 women of unknown serostatus who received varicella vaccine during pregnancy or within 3 months before pregnancy, none had newborns with abnormalities compatible with congenital varicella syndrome.

Patients and health care providers are encouraged to report any exposure to varicella-containing vaccine (Oka/Merck) during pregnancy by calling (800) 986-8999.

Nursing Mothers

The secretion of viruses in human milk has not been studied in measles and mumps vaccine viruses. Studies have shown that lactating postpartum women vaccinated with live rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. Limited evidence in the literature suggests that virus, viral DNA, or viral antigen could not be detected in the breast milk of women who were vaccinated postpartum with the vaccine strain of varicella virus.14-15 For additional information on transmission of vaccine virus from vaccine recipients to susceptible infants, see Transmission. ProQuad (measles mumps rubella varicella vaccine live) should not be administered to nursing women.

Pediatric Use

No clinical data are available on the safety, immunogenicity, and efficacy of ProQuad (measles mumps rubella varicella vaccine live) in children less than 12 months of age.

Geriatric Use

ProQuad (measles mumps rubella varicella vaccine live) is not indicated for use in the geriatric population ( > age 65).

REFERENCES

11. Committee on Infectious Diseases, American Academy of Pediatrics. In: Pickering LK, Baker CJ, Overturf GD, et al., eds. Red . Book: 2003 Report of the Committee on Infectious Diseases. 26th ed. Elk Grove Village, IL: American Academy of Pediatrics. 419-29,2003.

12. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention. MMWR. 38(22):388-392, 397-400, 1989.

13. Rubella vaccination during pregnancy-United States, 1971-1986. MMWR Morb Mortal Wkly Rep. 36(28):457-61, 1987.

14. Bohlke K, Galil K, Jackson LA, et al. Postpartum varicella vaccination: Is the vaccine virus excreted in breast milk? Obstetrics and Gynecology. 102(5): 970-977, 2003.

15. Dolbear GL, Moffat J, Falkner C and Wojtowycz M. A Pilot Study: Is attenuated varicella virus present in breast milk after postpartum immunization? Obstetrics and Gynecology. 101(4 Suppl.): 47S-47S, 2003.

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

ProQuad (measles mumps rubella varicella vaccine live) should not be administered

  • to individuals with a history of anaphylactic reactions to neomycin. If vaccination with ProQuad (measles mumps rubella varicella vaccine live) is medically necessary for such individuals, they are advised to consult an allergist or immunologist and should receive ProQuad (measles mumps rubella varicella vaccine live) only in settings where anaphylactic reactions can be appropriately managed.
  • to individuals with a history of hypersensitivity to gelatin or any other component of the vaccine (see WARNINGS for exceptions).
  • to individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system.
  • to individuals on immunosuppressive therapy (including high-dose systemic corticosteroids); ProQuad (measles mumps rubella varicella vaccine live) 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.
  • 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.10
  • to individuals with a family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
  • to individuals with active untreated tuberculosis.
  • to individuals with an active febrile illness with fever > 101.3°F ( > 38.5°C).
  • to individuals who are pregnant; the possible effects of the vaccine on fetal development are unknown at this time (see PRECAUTIONS, Pregnancy).

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Background

Measles, mumps, rubella, and varicella are 4 common childhood diseases caused by measles virus, mumps virus, rubella virus, and varicella virus, respectively. These diseases may ba associated with serious complications and/or death. For example, measles can be associated with pneumonia and encephalitis; mumps can be associated with aseptic meningitis, deafness, and orchitis; rubella occurring during pregnancy can cause congenital rubella syndrome in the infants of infected mothers; and wild-type varicella can be associated with bacterial superinfection, pneumonia, encephalitis, and Reye's syndrome.

Mechanism of action

In clinical efficacy studies, seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases. Also, in previous studies with varicella vaccine, antibody responses against varicella virus ≥ 5 units/mL in a glycoprotein enzyme-linked immunosorbent assay (gpELISA) (not commercially available) similarly correlated with long-term protection. Clinical studies with a single dose of ProQuad (measles mumps rubella varicella vaccine live) have shown that vaccination elicited rates of antibody responses against measles, mumps, and rubella that were similar to those observed after vaccination with a single dose of M-M-R II (see Clinical Studies) and seroresponse rates for varicella virus were similar to those observed after vaccination with a single dose of VARIVAX® (see Clinical Studies). The duration of protection from measles, mumps, rubella, and varicella infections after vaccination with ProQuad (measles mumps rubella varicella vaccine live) is unknown.

Persistence of Antibody Responses after Vaccination

The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2107 children enrolled in the clinical trials. Antibody was detected in 98.9% (1722/1741) for measles, 96.7% (1676/1733) for mumps, 99.6% (1796/1804) for rubella, and 97.5% (1512/1550) for varicella ( ≥ 5 gpELISA units/mL) of vaccinees following a single dose of ProQuad (measles mumps rubella varicella vaccine live) .

Experience with M-M-R II demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.1 Varicella antibodies were present for up to ten years post-vaccination in most of the individuals tested who received 1 dose of VARIVAX.

Clinical Studies

Formal studies to evaluate the clinical efficacy of ProQuad (measles mumps rubella varicella vaccine live) have not been performed.

Efficacy of the measles, mumps, rubella and varicella components of ProQuad (measles mumps rubella varicella vaccine live) was previously established in a series of clinical studies with the monovalent vaccines. A high degree of protection from infection was demonstrated in these studies.2-9

Immunogenicity

Immunogenicity was studied in 5835 healthy children 12 months to 6 years of age with a negative clinical history of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials. The immunogenicity of ProQuad (measles mumps rubella varicella vaccine live) was similar to that of its individual component vaccines (M-M-R II and VARIVAX), which are currently used in routine immunization.

The presence of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA for varicella. For evaluation of vaccine response rates, a positive result in the measles ELISA corresponded to measles antibody concentrations of > 255 mlU/mL when compared to the WHO II (66/202) Reference Immunoglobulin for Measles.

Children were positive for mumps antibody if the antibody level was ≥ 10 ELISA units/mL. A positive result in the rubella ELISA corresponded to concentrations of ≥ 10 IU rubella antibody/mL when compared to the WHO International Reference Serum for Rubella; children with varicella antibody levels ≥ 5 gpELISA units/mL were considered to be seropositive since a response rate based on ≥ 5 gpELISA units/mL has been shown to be highly correlated with long-term protection.

Children who received a single dose of ProQuad (measles mumps rubella varicella vaccine live) at 12-23 months of age

In 4 randomized clinical trials, 5446 healthy children 12 to 23 months of age were administered ProQuad (measles mumps rubella varicella vaccine live) , and 2038 children were vaccinated with M-M-R II and VARIVAX given concomitantly at separate injection sites. Subjects enrolled in each of these trials had a negative clinical history, no known recent exposure and no vaccination history for varicella, measles, mumps, and rubella. Children were excluded from study participation if they had an immune impairment or had a history of allergy to components of the vaccine(s). Except for in 1 trial (see Studies With Other Vaccines), no concomitant vaccines were permitted during study participation. Following a single dose of ProQuad (measles mumps rubella varicella vaccine live) , the vaccine response rates were 97.4% (95% CI: 96.9, 97.9) for measles, 95.8 (95% CI: 95.1, 96.4) to 98.8% (95% CI: 97.9, 99.4) for mumps, and 98.5% (95% CI: 98.1, 98.8) for rubella. The vaccine response rate was 91.2% (95% CI: 90.3, 92.0) for varicella. These results were similar to the immune response rates induced by concomitant administration of single doses of M-M-R II and VARIVAX at separate injection sites. Fever and measles-like rashes were the only adverse experiences that occurred more frequently in recipients of a single dose of ProQuad (measles mumps rubella varicella vaccine live) compared with recipients of single doses of M-M-R II and VARIVAX (see ADVERSE REACTIONS).

Children Who Received a Second Dose of ProQuad (measles mumps rubella varicella vaccine live)

In 2 of the 4 randomized clinical trials described above, a subgroup (N=1035) of the 5446 children administered a single dose of ProQuad (measles mumps rubella varicella vaccine live) were administered a second dose of ProQuad (measles mumps rubella varicella vaccine live) approximately 3 months after the first dose. Children were excluded from receiving a second dose of ProQuad (measles mumps rubella varicella vaccine live) if they were recently exposed to or developed varicella, measles, mumps, and/or rubella prior to receipt of the second dose. No concomitant vaccines were administered to these children. The proportion of initially seronegative vaccinees with positive serological responses following two doses were 99.4% (95% CI: 98.6, 99.8) for measles, 99.9% (95% CI: 99.4, 100) for mumps, 98.3% (95% CI: 97.2, 99.0) for rubella, and 99.4% (95% CI: 98.7, 99.8) for varicella ( ≥ 5 gpELISA units/mL). The geometric mean titers (GMTs) following the second dose of ProQuad (measles mumps rubella varicella vaccine live) increased approximately 2-fold each for measles, mumps, and rubella, and approximately 41-fold for varicella.

In these trials, the rates of adverse experiences after the second dose of ProQuad (measles mumps rubella varicella vaccine live) were generally similar to, or lower than, those seen with the first dose. The fever rate was lower after the second dose than after the first dose.

Children Who Received ProQuad (measles mumps rubella varicella vaccine live) at 4 to 6 Years of Age After Primary Vaccination With M-M-RII and VARIVAX

In a clinical trial involving 799 healthy 4- to 6-year-old children who had received M-M-R II and VARIVAX at least 1 month prior to study entry, 399 received ProQuad (measles mumps rubella varicella vaccine live) and placebo while 205 received M-M-R II and placebo concomitantly at separate injection sites. Another 195 healthy children were administered M-M-R II and VARIVAX concomitantly at separate injection sites. Children were eligible if they were previously administered primary doses of M-M-R II and VARIVAX, either concomitantly or non- concomitantly, at 12 months of age or older. Children were excluded if they were recently exposed to measles, mumps, rubella, and/or varicella, had an immune impairment, or had a history of allergy to components of the vaccine(s). No concomitant vaccines were permitted during study participation.

Following the dose of ProQuad (measles mumps rubella varicella vaccine live) , seropositivity rates were 99.2% (95% CI: 97.6, 99.8) for measles, 99.5% (95% CI: 98.0, 99.9) for mumps, 100% (95% CI: 99.0, 100) for rubella, and 98.9% (95% CI: 97.2, 99.7) for varicella ( ≥ 5 gpELISA units/mL). Approximate geometric mean fold-rises in antibody titers (pre- vaccination to post-vaccination) for measles, mumps, rubella, and varicella were 1.2, 2.4, 3.0 and 12, respectively. Post-vaccination GMTs for recipients of ProQuad (measles mumps rubella varicella vaccine live) were similar to those following a second dose of M-M-R II and VARIVAX administered concomitantly at separate injection sites. Additionally, GMTs for measles, mumps, and rubella were similar to those following a second dose of M-M-R II given concomitantly with placebo. The rates of adverse experiences, including the most commonly reported adverse experiences of injection site reactions, nasopharyngitis and cough were generally similar among the 3 treatment groups.

Studies With Other Vaccines

In a clinical trial involving 1913 healthy children 12 to 15 months of age, 949 received ProQuad (measles mumps rubella varicella vaccine live) plus Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and Haemophilus Influenzae type b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine concomitantly at separate injection sites. Another 485 healthy children received ProQuad (measles mumps rubella varicella vaccine live) at the initial visit followed by DTaP and Haemophilus b Conjugate and Hepatitis B (Recombinant) Vaccine given concomitantly 6 weeks later while 479 children were immunized with M-M-R II and VARIVAX given concomitantly at separate injection sites at the first visit. Seroconversion rates and antibody titers for measles, mumps, rubella, varicella, anti-PRP and hepatitis B were comparable between the 2 groups at approximately 6 weeks post-vaccination indicating the ProQuad (measles mumps rubella varicella vaccine live) and Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine may be administered concomitantly at separate injection sites. There are insufficient data to support concomitant immunization with diphtheria, tetanus and acellular pertussis vaccine. No clinically significant differences in adverse experiences were reported between treatment groups.

Herpes Zoster

2 cases of herpes zoster were reported in 2108 healthy subjects 12 to 23 months of age who were vaccinated with ProQuad (measles mumps rubella varicella vaccine live) in clinical trials and followed for 1 year. Both cases were unremarkable and no sequelae were reported (see ADVERSE REACTIONS, Other).

Reye's Syndrome

Reye's syndrome following wild-type varicella infection has occurred in children and adolescents, the majority of whom had received salicylates. In clinical studies of ProQuad (measles mumps rubella varicella vaccine live) or VARIVAX, the recommendation was made to avoid the use of salicylates for 6 weeks after vaccination. There were no reports of Reye's syndrome in recipients of ProQuad (measles mumps rubella varicella vaccine live) or VARIVAX during these studies.

REFERENCES

1. Weibel RE, et al. Clinical and laboratory studies of combined live measles, mumps, and rubella vaccines using the RA 27/3 rubella virus. Proc Soc Exp Biol Med. 165(2):323-326, 1980.

2. Hilleman MR, Stokes J, Jr., Buynak EB, Weibel R, Halenda R, Goldner H. Studies of live attenuated measles virus vaccine in man: II. appraisal of efficacy. Am J Public Health. 52(2):44-56, 1962.

3. Krugman S, Giles JP, Jacobs AM. Studies on an attenuated measles-virus vaccine: VI. clinical, antigenic and prophylactic effects of vaccine in institutionalized children. N EnglJ Med. 263(4):174-7,1960.

4. Hilleman MR, Weibel RE, Buynak EB, Stokes J, Jr., Whitman JE, Jr. Live, attenuated mumps-virus vaccine. 4. Protective efficacy as measured in a field evaluation. N Engl J Med. 276(5):252-8,1967.

5. Sugg WC, Finger JA, Levine RH, Pagano JS. Field evaluation of live virus mumps vaccine. J Pediatr. 72(4):461-6, 1968.

6. The Benevento and Compobasso Pediatricians Network for the Control of Vaccine-Preventable Diseases, D'Argenio P, Citarella A, Selvaggi MTM. Field evaluation of the clinical effectiveness of vaccines against pertussis, measles, rubella and mumps. Vaccine. 16(8):818-22,1998.

7. Furukawa T, Miyata T, Kondo K, Kuno K, Isomura S, Takekoshi T. Rubella vaccination during an epidemic. JAMA. 213(6):987-90, 1970.

8. Vazquez M, et al. The effectiveness of the varicella vaccine in clinical practice. N Engl J Med. 344(13):955-960, 2001.

9. Kuter B, et al. Ten year follow-up of healthy children who received one or two injections of varicella vaccine. Pediatr Infect Dis J. 23(2): 132-137, 2004.

10. Levy O, et al. Disseminated varicella infection due to the vaccine strain of varicella-zoster virus, in a patient with a novel deficiency in natural killer T cells. J Infect Dis. 188(7):948-53, 2003.

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The health care provider should provide the required vaccine information to the patient, parent, or guardian.

The health care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination.

The health care provider should tell the vaccine recipient or his or her parent or guardian that the vaccine recipient should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see DRUG INTERACTIONS).

Female vaccine recipients of childbearing age should be told to avoid pregnancy for 3 months following vaccination.

Patients, parents, or guardians should be told that vaccination with ProQuad (measles mumps rubella varicella vaccine live) may not offer 100% protection from measles, mumps, rubella, and varicella infection.

Patients, parents, or guardians should be instructed 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. The VAERS toll-free number for VAERS forms and information is 1-800-822-7967 or information may be submitted electronically via http://www.fda.gov/cber/vaers/vaers.htm

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

The health care provider should provide the required vaccine information to the patient, parent, or guardian.

The health care provider should inform the patient, parent, or guardian of the benefits and risks associated with vaccination.

The health care provider should tell the vaccine recipient or his or her parent or guardian that the vaccine recipient should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see DRUG INTERACTIONS).

Female vaccine recipients of childbearing age should be told to avoid pregnancy for 3 months following vaccination.

Patients, parents, or guardians should be told that vaccination with ProQuad (measles mumps rubella varicella vaccine live) may not offer 100% protection from measles, mumps, rubella, and varicella infection.

Patients, parents, or guardians should be instructed 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. The VAERS toll-free number for VAERS forms and information is 1-800-822-7967 or information may be submitted electronically via http://www.fda.gov/cber/vaers/vaers.htm

Last reviewed on RxList: 2/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Proquad Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

MEASLES/MUMPS/RUBELLA/VARICELLA VACCINE - INJECTION

(MEE-zulz/mumps/roo-BEL-a/VAR-i-SEL-a)

COMMON BRAND NAME(S): ProQuad

USES: This medication is a combination of vaccines against several virus infections: measles (also known as rubeola), mumps, rubella (also known as German measles), and varicella (also known as chickenpox). These are common childhood infections that may cause serious (rarely fatal) problems. Vaccination is the best way to protect against these infections. Vaccines work by causing the body to produce its own protection (antibodies).

This combination of vaccines is usually used in children between 12 months and 12 years old.

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This medication is given by injection by a health care professional. Depending on the brand of vaccine your child receives, it will be given either under the skin or into the muscle of the upper arm.

Vaccines are usually given in a series of doses to provide the best protection. Closely follow the vaccination schedule provided by the doctor. Keep all scheduled medical appointments. It may be helpful to mark a calendar as a reminder.

This combination of vaccines may be given at the same time as other childhood vaccines (such as haemophilus, hepatitis B) using a separate needle and injection site.

There are various combinations of vaccines available. Based on your child's age, vaccination history, and previous reaction to vaccines, the health care professional will decide which vaccines are best for your child. Discuss the risks and benefits of vaccination with the health care professional.

Disclaimer

Proquad Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, rash, and fussiness may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many children using this medication do not have serious side effects.

Tell the doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, joint pain/stiffness, seizures with fever.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call Health Canada at 1-866-234-2345.

Read the Proquad (measles mumps rubella varicella vaccine live) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before your child receives this product, tell the doctor or pharmacist if your child is allergic to it; or to eggs; or if your child has any other allergies. This product may contain inactive ingredients (such as neomycin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this product, tell the doctor or pharmacist your child's medical history, especially of: current fever/illness (such as untreated tuberculosis), bleeding/blood clotting problems (such as hemophilia, low platelets), blood cancer (such as leukemia, lymphoma), immune system problems (such as HIV infection), scheduled organ transplant, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

There is a small risk that your child may expose others to infection with chickenpox for up to 6 weeks after your child has been vaccinated. If possible, your child should avoid being in the same room with newborn babies (especially if born prematurely), pregnant women who have not had chickenpox, and people with immune system problems.

This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy for at least 3 months after vaccination.

This medication may pass into breast milk. However, it is unlikely to harm a nursing infant. Consult the doctor before breast-feeding.

Disclaimer

Proquad Consumer (continued)

DRUG INTERACTIONS: The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring your child for them. Do not start, stop, or change the dosage of any medicine before checking with your child's doctor or pharmacist first.

This product should not be used with the following products because very serious interactions may occur: drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy).

If your child is using any of these medications, tell the doctor or pharmacist before your child receives this product.

Before receiving this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products your child may use, especially of: corticosteroids taken by mouth or given by injection (such as dexamethasone), recent blood transfusion or use of blood products (such as immunoglobulins).

Avoid giving your child aspirin or aspirin-like medications (such as salsalate) for 6 weeks after your child has been vaccinated.

This product may interfere with certain laboratory tests (such as tuberculosis skin tests). Make sure laboratory personnel and all your child's doctors know that your child has recently received this product.

This document does not contain all possible interactions. Therefore, before your child receives this product, tell the doctor or pharmacist of all the products your child uses. Keep a list of all the medications with you, and share the list with the doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Even if your child has already had measles, mumps, rubella, or varicella virus infections, he or she may not be protected from getting them again. Your child should still receive this vaccine if the doctor orders it.

MISSED DOSE: It is important that your child receives each vaccination as scheduled. Be sure to make a note of when your child received their last vaccination for their medical record.

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

Information last revised September 2010. Copyright(c) 2010 First Databank, Inc.

Proquad Patient Information Including Side Effects

Brand Names: ProQuad

Generic Name: measles, mumps, rubella and varicella virus vaccine (Pronunciation: MEE zels, MUMPS, roo BEL a, var i SEL a)

What is measles, mumps, rubella, and varicella virus vaccine (Proquad)?

Measles, mumps, rubella, and varicella are serious diseases caused by viruses. They are spread from person to person through the air.

Measles virus can cause minor symptoms such as skin rash, cough, runny nose, eye irritation, or mild fever. It can also cause more serious symptoms such as ear infection, pneumonia, seizures, permanent brain damage, or death.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

Rubella virus (also called German Measles) causes skin rash, mild fever, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

Varicella (commonly known as chickenpox) is a common childhood disease that causes fever, skin rash, and a breakout of fluid-filled blisters on the skin. Most people who receive this vaccine will not get chickenpox, or will get only a mild case and will recover faster. Chickenpox is usually mild, but it can be serious or even fatal in young infants and in adults. It can lead to severe skin infection, breathing problems, brain damage, or death. A person who has had chickenpox can develop herpes zoster (also called shingles) later in life, which causes severe nerve pain, and hearing or vision problems, which may last for months or years.

Measles, mumps, rubella, and varicella are spread from person to person.

The measles, mumps, rubella, and varicella vaccine is used to help prevent these diseases in children. This vaccine works by exposing your child to a small dose of the virus or a protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, rubella, and varicella vaccine is for use in children between the ages of 12 months and 12 years old.

Like any vaccine, the measles, mumps, rubella, and varicella vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Proquad)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • problems with hearing or vision;
  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • easy bruising or bleeding, unusual weakness;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • headache, dizziness;
  • low fever, joint or muscle pain; or
  • nausea, vomiting, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Proquad (measles mumps rubella varicella vaccine live) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about this vaccine (Proquad)?

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

Side Effects Centers

Proquad Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving this vaccine (Proquad)?

Your child should not receive this vaccine if he or she is allergic to eggs, gelatin, or neomycin (Mycifradin, Neo-Fradin, Neo-Tab), or if the child has ever had a life-threatening allergic reaction to any vaccine containing measles, mumps, rubella, or varicella.

Your child should also not receive this vaccine if he or she has:

  • active tuberculosis infection;
  • a cancer such as leukemia or lymphoma;
  • a history of Guillain-Barré syndrome;
  • a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or a blood cell disorder such as anemia;
  • severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation;
  • if the child has recently taken aspirin or other similar medicines such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others;
  • if the child has recently received a stem cell transplant;
  • if someone in the child's household has a weak immune system; or
  • if the child is pregnant.

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

  • thrombocytopenia purpura (easy bruising or bleeding);
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments;
  • if the child has received an immune globulin or other blood product within the past year; or
  • if the child has received a measles, mumps, and rubella (MMR) vaccine within the past 28 days (4 weeks).

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Pregnant women should wait to get this vaccine until after they have given birth. Women should not get pregnant for 3 months after getting the vaccine.

A woman should not receive this vaccine without telling the doctor if she is breast-feeding a baby.

How is this vaccine given (Proquad)?

This vaccine is given as an injection under the skin. You will receive this injection in a doctor's office or clinic setting.

The measles, mumps, rubella, and varicella vaccine is usually given only once when the child is between 12 months and 12 years old. If a booster dose is needed, At least 3 months should pass between the first and second doses of this vaccine.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis for up to 6 weeks. Tell any doctor who treats you if you have received this vaccine within the past 4 to 6 weeks.

Side Effects Centers

Proquad Patient Information including If I Miss a Dose

What happens if I miss a dose (Proquad)?

Since this vaccine is usually given only once, you are not likely to miss a dose. Contact your doctor if you do not receive all recommended doses.

What happens if I overdose (Proquad)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Proquad)?

Your child should not receive another "live" vaccine for at least 4 weeks after receiving the measles, mumps, rubella, and varicella vaccine. The other live vaccine may not work as well during this time, and may not fully protect your child from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Do not give your child salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others for at least 6 weeks after receiving this vaccine. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.

What other drugs will affect measles, mumps, rubella, and varicella virus vaccine (Proquad)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If your child is receiving any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications your child receives. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 9/9/2011.

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