ProQuad

What is ProQuad used for?

ProQuad is used to prevent measles, mumps, rubella (German measles), and varicella (chickenpox).

Description

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 not less than 3.99 log10 PFU of Oka/Merck varicella virus.

After reconstitution, each 0.5-mL dose of the vaccine also contains 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 recombinant human albumin, 0.17 mg of sodium bicarbonate, 72 mcg of potassium phosphate monobasic, 60 mcg of potassium chloride; 36 mcg of potassium phosphate dibasic; and residual components from the manufacturing process: MRC-5 cells including DNA and protein; <16 mcg of neomycin, ≤0.5 mcg of bovine calf serum, and other buffer and media ingredients. The product contains no preservative.

 Mechanism of Action

ProQuad has been shown to induce measles-, mumps-, rubella-, and varicella-specific immunity, which is thought to be the mechanism by which it protects against these four childhood diseases.

The efficacy of ProQuad was established through the use of immunological correlates for protection against measles, mumps, rubella, and varicella. Results from efficacy studies or field effectiveness studies that were previously conducted for the component vaccines were used to define levels of serum antibodies that correlated with protection against measles, mumps, and rubella. Also, in previous studies with varicella vaccine, antibody responses against varicella virus ≥5 gpELISA units/mL in a glycoprotein enzyme-linked immunosorbent assay (gpELISA) (not commercially available) similarly correlated with long-term protection.

In these efficacy studies, the clinical endpoint for measles and mumps was a clinical diagnosis of either disease confirmed by a 4-fold or greater rise in serum antibody titers between either postvaccination or acute and convalescent titers; for rubella, a 4-fold or greater rise in antibody titers with or without clinical symptoms of rubella; and for varicella, varicella-like rash that occurred >42 days postvaccination and for which varicella was not excluded by either viral cultures of the lesion or serological tests. Specific laboratory evidence of varicella either by serology or culture was not required to confirm the diagnosis of varicella. Clinical studies with a single dose of ProQuad 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 and seroresponse rates for varicella virus were similar to those observed after vaccination with a single dose of VARIVAX . The duration of protection from measles, mumps, rubella, and varicella infections after vaccination with ProQuad is unknown.

Before taking ProQuad, tell your doctor:

• If your child has an allergy to any part of ProQuad.
• If your child is allergic to ProQuad; any part of this medicine; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has any of these health problems: A blood disease, a weak immune system like HIV or AIDS, active TB (tuberculosis) that is not being treated, an illness with a fever, cancer, or low blood levels of gamma globulin.
• If your child is taking any drugs to suppress the immune system. This may be certain doses of steroids like prednisone. This does not apply to children taking steroids for certain health problems like Addison’s disease. There are many drugs that can suppress the immune system. Ask your child’s doctor or pharmacist if you are not sure.
• If your child has had any of these within the past 5 months: Blood transfusion, plasma transfusion, immune globulin like varicella-zoster immune globulin.

If your child is pregnant:

• If your child is pregnant or plans to get pregnant within the next 3 months. Do not give ProQuad to your child if she is pregnant or if she is planning to get pregnant within the next 3 months.

This is not a list of all drugs or health problems that interact with this medicine.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take ProQuad with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while I take ProQuad?

• Tell all of your child’s health care providers that your child is taking ProQuad. This includes your child’s doctors, nurses, pharmacists, and dentists.
• If your child has a TB skin test soon after getting this vaccine, tell the doctor that your child has gotten the vaccine.
• This medicine may not protect all people who use it. Talk with the doctor.
• Rarely, your child can spread the chickenpox virus to others after getting this vaccine. When able to, have your child avoid close contact with certain people. People like newborns, pregnant women who have not had chickenpox, and people with weak immune systems. Do this for up to 6 weeks after your child gets this vaccine. Talk with the doctor if your child cannot avoid close contact with these people.
• Children may have a fever after getting this vaccine. Some children have had a seizure caused by fever. Talk with your child’s doctor.
• If your child is allergic to eggs, talk with the doctor.
• Do not give aspirin or products like aspirin for at least 6 weeks after your child gets this vaccine. The chance of a very bad illness called Reye’s syndrome may be raised. Reye’s syndrome causes damage to the brain and liver.
• Do not give ProQuad to a child younger than 1 year of age.
• This medicine is not approved for use in children older than 12 years of age or in adults. Talk with the doctor.

If your child is pregnant or breast-feeding a baby:

• This medicine may cause harm to the unborn baby if your child takes it during pregnancy.
• If your child gets pregnant within 3 months after getting this vaccine, call the doctor right away.
• Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

How is ProQuad best taken?

Give ProQuad as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot under the skin.

What do I do if I miss a dose?

• Call your child’s doctor to find out what to do.

What are the side effects of ProQuad that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• High fever.
• Seizures.
• Rarely, other side effects have happened with ProQuad. It is not known if ProQuad caused these side effects. Call your child’s doctor right away if your child has easy bruising; red or purple, flat spots under the skin; pale skin; trouble walking; severe skin problems, or a skin infection. Call your child’s doctor right away if your child has a headache, fever, chills, very upset stomach or throwing up, stiff neck, seizures, feels sleepy or confused, or if bright lights bother your child’s eyes.

What are some other side effects of ProQuad?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Pain, redness, or swelling where the shot was given.
• Mild fever.
• Feeling fussy.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out ProQuad?

• If you need to store ProQuad at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.