ProQuad

ProQuad is a vaccine that prevents measles, mumps, rubella, and varicella (chicken pox) in children 12 months through 12 years of age.

Caution should be used 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
• children with allergies to eggs or neomycin
• children with thrombocytopenia (low amount of platelets in the blood which increases the risk of bleeding)
• children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella (chicken pox), nor had the infections since they have higher rates of fever and fever realted seizures at 5 to 12 days after vaccination when compared to children vaccinated with M-M-R II and Varivax administered separately

Avoid the following after receiving ProQuad:

• Vaccination should be delayed for at least 3 months following blood or plasma transfusions, or administration of immune globulins.
• Avoid using salicylates for 6 weeks after vaccination with ProQuad.
• Avoid pregnancy for 3 months following vaccination with measles, mumps, rubella, and/or varicella 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, and at least 3 months should elapse between administration of 2 doses of ProQuad or varicella-containing vaccines

Do not take ProQuad if you:

• have a history of anaphylactic (allergic) reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine
• have a weakened immune system (immunodeficiency)
• have a family history of congenital or hereditary immunodeficiency
• you are taking drugs that weaken the immune system
• have active untreated tuberculosis or fever greater than 101.3°F
• you are pregnanct

ProQuad is a vaccine that is given as a shot just under the skin (subcutaneous) of the upper arm or thigh. The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R II (measles, mumps, and rubella virus vaccine live) and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and 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.

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.

It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after your child receive this vaccine.

Do not become pregnant for 3 months after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away.

Children who have received this vaccine have developed a fever and in some cases a fever with seizures. Talk with your child's doctor if you have concerns about this.

Your child should avoid close contact with people at high risk for catching the varicella virus for 6 weeks after receiving this vaccine. People who are at risk for catching the virus are pregnant women, newborn babies, and anyone who has a weak immune system that keeps them from fighting infections.

Tell your doctor that you have received this vaccine:

• If you are to receive blood transfusions or other blood products within 3 months of receiving this vaccine.
• If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 3 to 5 months after receiving this vaccine.
• If you are to have a tuberculin skin test within 4 to 6 weeks after receiving this vaccine.
• If you are to receive any other live virus vaccines within 1 or 3 months of receiving this vaccine.

Do not take aspirin or medicines that contain aspirin (such as cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you give to your child to be sure it does not contain aspirin or salicylic acid.

This vaccine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob Disease) to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your child's doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For all patients taking ProQuad (measles, mumps, rubella, and varicella virus vaccine injection):

• If your child has an allergy to any part of this medicine.
• If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• 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 in the bone marrow or lymph systems like leukemia or lymphoma, 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.

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 where the shot was given.
• Redness or swelling where the shot is given.
• 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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

ProQuad1 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.

Registered trademark of Merck & Co., Inc.
Copyright © 2009 Merck & Co., Inc.
All rights reserved

Your child should not receive ProQuad 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 ProQuad 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, the ProQuad vaccination 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 ProQuad.

Pregnant women should wait to get ProQuad vaccine until after they have given birth. Women should not get pregnant for 3 months after getting the vaccine. A woman should not receive ProQuad without telling the doctor if she is breast-feeding a baby.

Your child should not receive another "live" vaccine for at least 4 weeks after receiving the ProQuad 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 ProQuad. A serious condition called Reye's Syndrome has been reported in patients with chickenpox who take aspirin or salicylates.