Measles, Mumps, and Rubella Virus Vaccine Live

Name: Measles, Mumps, and Rubella Virus Vaccine Live

Indications

Recommended Vaccination Schedule

M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

Individuals first vaccinated at 12 months of age or older should be revaccinated prior to elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of M-M-R II at 12 to 15 months of age and administration of the second dose of M-M-R II at 4 to 6 years of age.59 In addition, some public health jurisdictions mandate the age for revaccination. Consult the complete text of applicable guidelines regarding routine revaccination including that of high-risk adult populations.

Measles Outbreak Schedule

Infants Between 6 to 12 Months of Age

Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion (see CLINICAL PHARMACOLOGY). Such infants should receive a second dose of M-M-R II between 12 to 15 months of age followed by revaccination at elementary school entry.59

Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian.

Other Vaccination Considerations

Non-Pregnant Adolescent and Adult Females

Immunization of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see below and PRECAUTIONS). Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the fetus and consequent congenital rubella injury.33

Women of childbearing age should be advised not to become pregnant for 3 months after vaccination and should be informed of the reasons for this precaution.

The ACIP has stated “If it is practical and if reliable laboratory services are available, women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, with the exception of premarital and prenatal screening, routinely performing serologic tests for all women of childbearing age to determine susceptibility (so that vaccine is given only to proven susceptible women) can be effective but is expensive. Also, 2 visits to the health-care provider would be necessary — one for screening and one for vaccination. Accordingly, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing — and may be preferable, particularly when costs of serology are high and follow-up of identified susceptible women for vaccination is not assured.”33

Postpubertal females should be informed of the frequent occurrence of generally self-limited arthralgia and/or arthritis beginning 2 to 4 weeks after vaccination (see ADVERSE REACTIONS).

Postpartum Women

It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period (see PRECAUTIONS, Nursing Mothers).

Other Populations

Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine (such as that contained in monovalent rubella vaccine or in M-M-R II) to reduce the risk of exposure of the pregnant woman.

Individuals planning travel outside the United States, if not immune, can acquire measles, mumps, or rubella and import these diseases into the United States. Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can either receive the indicated monovalent vaccine (measles, mumps, or rubella), or a combination vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travelers should receive M-M-R II regardless of their immune status to mumps or rubella.34-36

Vaccination is recommended for susceptible individuals in high-risk groups such as college students, health-care workers, and military personnel.33,34,37

According to ACIP recommendations, most persons born in 1956 or earlier are likely to have been infected with measles naturally and generally need not be considered susceptible. All children, adolescents, and adults born after 1956 are considered susceptible and should be vaccinated, if there are no contraindications. This includes persons who may be immune to measles but who lack adequate documentation of immunity such as: (1) physician-diagnosed measles, (2) laboratory evidence of measles immunity, or (3) adequate immunization with live measles vaccine on or after the first birthday.34

The ACIP recommends that “Persons vaccinated with inactivated vaccine followed within 3 months by live vaccine should be revaccinated with two doses of live vaccine. Revaccination is particularly important when the risk of exposure to wild-type measles virus is increased, as may occur during international travel.”34

Post-Exposure Vaccination

Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours of exposure. If, however, vaccine is given a few days before exposure, substantial protection may be afforded.34,38,39 There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.33,37

Use With Other Vaccines

See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.

Patient information

M-M-R® II
(pronounced “em em ar too”)

Generic name: Measles, Mumps, and Rubella Virus Vaccine Live

This is a summary of information about M-M-R II*. You should read it before you or your child receives the vaccine. If you have any questions about the vaccine after reading this leaflet, you should ask your health care provider. This is a summary only. It does not take the place of talking about M-M-R II with your doctor, nurse, or other health care provider. Only your health care provider can decide if M-M-R II is right for you or your child.

What is M-M-R II and how does it work?

M-M-R II is also known as Measles, Mumps, and Rubella Virus Vaccine Live. It is a live virus vaccine that is given as a shot. This vaccine is usually given to people one year old or older. It is meant to help prevent measles (rubeola), mumps, and rubella (German measles).

M-M-R II contains weakened forms of measles virus, mumps virus, and rubella virus.

M-M-R II works by helping the immune system protect you or your child from getting measles, mumps, or rubella.

M-M-R II may not protect everyone who gets the vaccine. M-M-R II does not treat measles, mumps, or rubella once you or your child has them.

What do I need to know about measles, mumps, and rubella?

Measles is also known as rubeola. It is a serious illness. Measles virus can be passed to others if you have it. Measles can give you a high fever, cough, and a rash. The illness can last for 1 to 2 weeks. In rare cases, it can also cause an infection of the brain. This could lead to seizures, hearing loss, mental retardation, and even death.

Mumps can also be passed to others. This virus can cause fever and headache. It also makes the glands under your jaw swell and be painful. The illness often lasts for several days. Sometimes, mumps can make the testicles swell and be painful. In some cases, it can cause meningitis, which is a mild swelling of the coverings of the brain and spinal cord.

Rubella is also known as German measles. It is often a mild illness. Rubella virus can cause a mild fever, swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for a short time. It can be very dangerous if a pregnant woman catches it. Women who catch German measles when they are pregnant can have babies who are stillborn. Also, the babies may be blind or deaf, or have heart disease or mental retardation.

Who should not get M-M-R II?

Do not get M-M-R II if you or your child:

  • are allergic to any of its ingredients (This includes gelatin or neomycin. See the ingredient list at the end of this leaflet.);
  • have a weakened immune system, such as an immune deficiency, an inherited immune disorder, leukemia, lymphoma, or HIV/AIDS;
  • take high doses of steroids by mouth or in a shot;
  • have a fever higher than 101.3°F (38.5°C);
  • are pregnant or plan to get pregnant within the next three months.

What should you tell your health care provider before getting M-M-R II?

Tell your health care provider if you or your child:

  • have or have had any medical problems;
  • have a history of seizures or a brain injury;
  • have received blood or plasma transfusions or human serum globulin;
  • have active tuberculosis that is not treated;
  • take any medicines (This includes non-prescription medicines and dietary supplements.);
  • have any allergies (This includes allergies to neomycin or gelatin.);
  • had an allergic reaction to any other vaccine;
  • are pregnant or plan to become pregnant within the next three months;
  • are breast-feeding;
  • have or have had a low blood platelet count;
  • are allergic to eggs.

How is M-M-R II given?

M-M-R II is given as a shot to people one year old or older. The dose of the vaccine is the same for everyone. If your child gets the shot when he or she is one year old or older, a second dose is recommended. Often, the second dose is given right before the child goes to elementary school (4 to 6 years of age). If your child is less than one year old when he or she first gets the shot, a second dose should be given when they are 12 to 15 months old. Then, a third shot should be given between 4 and 6 years of age. Your doctor will decide the best time and number of shots by using official recommendations.

If a dose is missed, your health care provider will let you know when you should have it.

Non-pregnant adolescent and adult females of childbearing age who are susceptible to rubella can be vaccinated with M-M-R II (or live attenuated rubella virus vaccine) if certain precautions are taken. In many cases, it is convenient to give the vaccine to women at risk for rubella right after they give birth.

What are the possible side effects of M-M-R II?

The most common side effect of vaccination with M-M-R II is burning and/or stinging at the site of the shot for a short time.

Other side effects may include:

  • Fever
  • Rash

Less common side effects may also include:

  • Swelling of the testicles
  • Joint pain and/or swelling

Some side effects are rare but may be serious. You should call your health care provider if you notice any of the following problems:

  • Difficulty breathing, wheezing, hives, or a skin rash may be signs of an allergic reaction.
  • Bleeding or bruising under the skin.
  • Seizures, a severe headache, or a change in behavior or consciousness.

Other side effects may also occur. Your doctor has a more complete list of side effects for M-M-R II.

Contact your doctor or health care provider if you or your child have any new or unusual symptoms after receiving M-M-R II.

You may also report any adverse reactions to your doctor or your child's health care provider or submit a report directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or you may report online to www.vaers.hhs.gov.

What are the ingredients of M-M-R II?

Active Ingredients: weakened forms of the measles, mumps, and rubella viruses.

Inactive Ingredients: sorbitol, sodium phosphate, potassium phosphate, sucrose, sodium chloride, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, other buffer and media ingredients, neomycin.

What else should I know about M-M-R II?

If you get M-M-R II while you are pregnant, please call 1-800-986-8999. Or, you can have your health care provider call.

This leaflet summarizes important information about M-M-R II.

If you would like more information, talk to your health care provider or call 1-800-622-4477. Rx Only Issued November 2013

What is the most important information i should know about this vaccine (m-m-r ii)?

The measles, mumps, and rubella (MMR) vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. At least 28 days (4 weeks) should pass between the first and second doses of this vaccine.

Adults born after 1956 should receive at least one MMR vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

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

Be sure to receive all recommended doses of this vaccine. You may not be fully protected against disease if you do not receive the full series.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your 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.

Where can i get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information 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 1996-2013 Cerner Multum, Inc. Version: 3.01. Revision date: 7/28/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Side effects

The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella:

Body as a Whole

Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Pancreatitis; diarrhea; vomiting; parotitis; nausea.

Endocrine System

Diabetes mellitus.

Hemic and Lymphatic System

Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; regional lymphadenopathy; leukocytosis.7

Immune System

Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history.

Musculoskeletal System

Arthritis; arthralgia; myalgia.

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 sex, being greatest in adult females and least in prepubertal children. This type of involvement as well as myalgia and paresthesia, have also been reported following administration of MERUVAX II.

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.

Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-26%),17,52,53 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 in adult women. Even in women older than 35 years, these reactions are generally well tolerated and rarely interfere with normal activities.

Nervous System

Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see CONTRAINDICATIONS); subacute sclerosing panencephalitis (SSPE); Guillain-Barr� Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.

Experience from more than 80 million doses of all live measles vaccines given in the U.S. through 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine very rarely.54 In no case has it been shown that reactions were actually caused by vaccine. The Centers for Disease Control and Prevention has pointed out that “a certain number of cases of encephalitis may be expected to occur in a large childhood population in a defined period of time even when no vaccines are administered”. 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 (one per two thousand reported cases).

Post-marketing surveillance of the more than 200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971 to 1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.17

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 nationwide measles vaccine distribution, 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, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.55

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

Respiratory System

Pneumonia; pneumonitis (see CONTRAINDICATIONS); sore throat; cough; rhinitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; measles-like rash; pruritis.

Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema); swelling; induration; tenderness; vesiculation at injection site.

Special Senses - Ear

Nerve deafness; otitis media.

Special Senses - Eye

Retinitis; optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.

Urogenital System

Epididymitis; orchitis.

Other

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 (see CONTRAINDICATIONS). No deaths or permanent sequelae were 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 1993.56

Under the National Childhood Vaccine Injury Act of 1986, health-care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.47 A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967.

Read the entire FDA prescribing information for M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live)

Read More »
(web3)