Pronunciation:

MEE-zuls VYE-rus VAX-een, lyve, mumps VYE-rus VAX-een, lyve, roo-BELL-a VYE-rus VAX-een, lyve

Brand Names:

• M-M-R II

Dosage Forms:

• Powder for Solution
• Powder for Suspension

Classifications:

Therapeutic—

Vaccine, Live

Uses of This Medicine:

Measles, mumps, and rubella virus vaccine (live) is an active immunizing agent that is given to protect against infections caused by measles, mumps, and rubella (German measles). It works by causing your body to produce its own protection (antibodies) against the virus.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and 10-day measles) is an infection that is easily spread from one person to another. Infection with measles can cause serious problems, including stomach problems, pneumonia, ear infections, sinus problems, convulsions (seizures), brain damage, and possibly death. The risk of serious complications and death is greater for adults and infants than for children and teenagers.

Mumps is an infection that can cause serious problems, such as encephalitis and meningitis, which affect the brain. In addition, adolescent boys and men are very susceptible to a condition called orchitis, which causes pain and swelling in the testicles and scrotum and, in rare cases, sterility. Also, mumps infection can cause spontaneous abortion (miscarriage) in women during the first 3 months of pregnancy.

Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Priorix® injection in infants younger than 12 months of age. Safety and efficacy have not been established.

Use of M-M-R® II is not recommended in children younger than 12 months of age. Safety and efficacy have not been established for measles vaccine in children younger than 6 months of age and for mumps and rubella vaccine in children younger than 12 months of age.

Older adults—

Appropriate studies on the relationship of age to the effects of Priorix® and M-M-R® II injection have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Priorix® injection in the elderly.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Alemtuzumab
• Bendamustine
• Bortezomib
• Bosutinib
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deflazacort
• Docetaxel
• Doxorubicin
• Epirubicin
• Etoposide
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Procarbazine
• Rituximab
• Temozolomide
• Teniposide
• Thiotepa
• Topotecan
• Tositumomab
• Vinblastine
• Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Betibeglogene Autotemcel
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Meningococcal Vaccine
• Mycophenolic Acid
• Ocrelizumab
• Ozanimod
• Ponesimod
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rozanolixizumab-noli
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Trabectedin
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Voclosporin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to eggs, history of—May increase risk for a serious allergic reaction to occur again.

• Immune system problems—Use with caution. This condition may decrease the useful effects of the vaccine.

• Immune system problems, severe or
• Tuberculosis, active and untreated—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. It is given as a shot under your skin (usually in the thighs) or into one of your muscles.

This vaccine is given in 2 doses. First dose is given at 12 to 15 months of age, while the second dose is given at 4 to 6 years of age. If this vaccine is not given on time, 2 doses will be given at least 4 weeks apart.

If you have received 1 dose of another authorized or approved measles, mumps, and rubella vaccine, you may receive a second dose of Priorix® to complete your vaccination series.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

Do not become pregnant for 1 month 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.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Fainting may occur after you receive this vaccine. You may also have vision changes, numbness or tingling in your arms, hands, or feet, or jerky movements of the arms and legs. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

The tip caps of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.

This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of measles, mumps, and rubella infection if you already have the disease.

Tell your doctor that you have received this vaccine:

• If you are to receive a tuberculin skin test within 4 to 6 weeks after receiving this vaccine. The results of the test may be affected by this vaccine.
• If you are to receive any other live virus vaccines within 1 month after receiving this vaccine.
• If you are to receive blood transfusions or other blood products within 2 weeks after receiving this vaccine.
• If you are to receive gamma globulin or other globulins within 2 weeks after receiving this vaccine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Difficulty in breathing or swallowing

fever over 39 °C (102 °F)

itching, especially of the feet or hands

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness

Less common

Difficulty in moving

joint pain

muscle pain or stiffness

Incidence not known

Back pain, sudden and severe

black, tarry stools

bleeding gums

blindness or vision changes

blood in the urine or stools

bloody nose

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

burning of the face or mouth

change in walking and balance

chest tightness

clumsiness or unsteadiness

confusion

cough

dizziness

drowsiness

fainting

fast heartbeat

fever

general feeling of illness

heavier menstrual periods

inability to move the arms and legs

irritability

large, flat, blue, or purplish patches in the skin

muscle weakness, sudden and progressing

nausea

pain in the stomach, groin, or scrotum

pain or burning with urination

painful knees and ankles

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

raised red swellings on the skin, the buttocks, legs, or ankles

seizures

severe headache

skin rash

stiff neck or back

stomach pain

sudden numbness and weakness in the arms and legs

swelling of the scrotum

swollen, painful, or tender lymph glands on the side of the face or neck

unusual bleeding or bruising

vomiting

weakness in the hands or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

loss of appetite

sleepiness

Less common

Runny nose

sore throat

vague feeling of bodily discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.