ProQuad: Measles, Mumps, Rubella and Varicella Virus Vaccine Live: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ProQuad safely and effectively. See full prescribing information for ProQuad

See full insert sheet at this link at the Natural News Reference website.

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

Suspension for subcutaneous injection

Initial U.S. Approval: 2005

INGREDIENTS AND EXCIPIENTS

ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilized preparation of (1) the components of M-M-R II (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 virus 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 recombinant human albumin used in manufacturing are all tested to provide assurance that the final product is free of potential adventitious agents.

ProQuad, when reconstituted as directed, is a sterile suspension for subcutaneous administration. Each 0.5-mL dose contains not less than 3.00 log10 TCID50 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 of Oka/Merck varicella virus.

Each 0.5-mL dose of the vaccine nominally contains 20 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.5 mg of urea; 2.3 mg of sodium chloride, 16 mg of sorbitol, 0.38 mg of monosodium L-glutamate, 1.4 mg of sodium phosphate, 0.25 mg of recombinant human albumin, 0.13 mg of sodium bicarbonate, 94 mcg of potassium phosphate, 58 mcg of potassium chloride; residual components of MRC-5 cells including DNA and protein; 5 mcg of neomycin, bovine serum albumin (0.5 mcg), and other buffer and media ingredients. The product contains no preservative.

INDICATIONS AND USAGE

ProQuad is a vaccine indicated for active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age. (1)

DOSAGE AND ADMINISTRATION

A 0.5-mL dose for subcutaneous injection only. (2.1)

– The first dose is usually administered at 12 to 15 months of age. (2.1)

– A second dose, if needed, is usually administered at 4 to 6 years of age. (2.1)

DOSAGE FORMS AND STRENGTHS

Suspension for injection (0.5-mL dose) supplied as a lyophilized vaccine to be reconstituted using only accompanying sterile diluent. (2.2, 3)

CONTRAINDICATIONS

History of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine. (4.1)

Primary or acquired immunodeficiency states. (4.2)

Family history of congenital or hereditary immunodeficiency. (4.2)

Immunosuppressive therapy. (4.2, 7.3)

Active untreated tuberculosis or febrile illness (>101.3°F or >38.5°C). (4.3)

Pregnancy. (4.4, 8.1, 17)

WARNINGS AND PRECAUTIONS

Administration of ProQuad (dose 1) to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination when compared to children vaccinated with M-M-R® II and VARIVAX® administered separately. (5.1, 6.1, 6.3)

Use caution when administering ProQuad to children with a history of cerebral injury or seizures or any other condition in which stress due to fever should be avoided. (5.2)

Use caution when administering ProQuad to children with anaphylaxis or immediate hypersensitivity to eggs (5.3) or contact hypersensitivity to neomycin. (5.4)

Use caution when administering ProQuad to children with thrombocytopenia. (5.5)

Avoid close contact with high-risk individuals susceptible to varicella since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts. (5.8)

Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG). (5.9, 7.1) • Avoid using salicylates for 6 weeks after vaccination with ProQuad. (5.10, 7.2, 17)

Avoid pregnancy for 3 months following vaccination with measles, mumps, rubella, and/or varicella vaccines. (8.1, 17)

ADVERSE REACTIONS

The most frequent vaccine-related adverse events reported in ≥5% of subjects vaccinated with ProQuad were:

– injection-site reactions (pain/tenderness/soreness, erythema, and swelling)

– fever

– irritability

Systemic vaccine-related adverse events that were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were:

– fever

– measles-like rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

Tuberculin testing should be administered anytime before, simultaneously with, or at least 4 to 6 weeks after ProQuad. (7.4)

ProQuad may be administered concomitantly with Haemophilus influenzae type b conjugate vaccine and/or hepatitis B vaccine at separate injection sites. (7.5)

ProQuad may be administered concomitantly with pneumococcal 7-valent conjugate vaccine and/or hepatitis A vaccine (inactivated) at separate injection sites. (7.5)

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

ProQuad vaccine contains live attenuated measles, mumps, rubella and varicella viruses. The vaccine is contraindicated for use in pregnant women because infection during pregnancy with the wild-type viruses is associated with maternal and fetal adverse outcomes.

For women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of administration of ProQuad, the healthcare provider 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 infection with wild-type measles during pregnancy. There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy; (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 {7}; (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 RA 27/3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome {8}; and (4) Wild-type varicella, if acquired during pregnancy, can sometimes cause congenital varicella syndrome.

Available data on inadvertent administration of ProQuad to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

There are no relevant animal data.

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively {9,10}.

Data

Human Data

In a 10-year CDC 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 {8}.

Lactation

Risk Summary

It is not known whether varicella, measles, or mumps vaccine virus is excreted in human milk. Studies have shown that lactating postpartum women vaccinated with live rubella vaccine may secrete the virus in breast milk and transmit it to breastfed infants. {11,12}. [See Warnings and Precautions (5.8).]

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ProQuad, and any potential adverse effects on the breastfed child from ProQuad or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

Do not administer ProQuad to infants younger than 12 months of age or to children 13 years and older. Safety and effectiveness of ProQuad in infants younger than 12 months of age and in children 13 years and older have not been studied. ProQuad is not approved for use in persons in these age groups. [See Adverse Reactions (6) and Clinical Studies (14).]

Geriatric Use

ProQuad is not indicated for use in the geriatric population (≥age 65)

Revised: 03/2017

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123793.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/ProQuad-Measles-Mumps-Rubella-and-Varicella-Virus-Vaccine.pdf