Pronunciation:

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

Uses of This Medicine:

Measles, mumps, rubella, and varicella virus vaccine (live) is an active immunizing agent that is given to protect against infections caused by measles (rubeola), mumps, rubella (German measles), and varicella (chickenpox) viruses. The combination vaccine works by causing the 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, such as 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, teenage 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.

Varicella (commonly known as chickenpox) is an infection that is easily spread from one person to another. Chickenpox is usually a mild infection but can sometimes cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease, called Reye's syndrome.

This vaccine is to be administered only by or under the supervision of your doctor or other healthcare 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—

Use is not recommended in infants younger than 12 months of age or in children 13 years of age and older. Safety and efficacy have not been established.

Older adults—

This vaccine is not recommended for use in elderly patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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
• Aspirin
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Benorilate
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Choline Salicylate
• Cyclosporine
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Etrasimod
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Lovotibeglogene Autotemcel
• Meningococcal Vaccine
• Mesalamine
• Mirikizumab-mrkz
• Mycophenolic Acid
• Ocrelizumab
• Olsalazine
• Ozanimod
• Ponesimod
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rozanolixizumab-noli
• Salicylamide
• Salicylic Acid
• Salsalate
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Sodium Salicylate
• Sodium Thiosalicylate
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Trabectedin
• Tralokinumab-ldrm
• Trolamine Salicylate
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• 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.

• Brain injury or
• Seizures, history of or
• Thrombocytopenia (not enough platelets in the blood) or history of—Use with caution. May make these conditions worse.

• 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 upper arms or 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.

Your child may receive certain other vaccines at the same time as this one, but in a different body area.

This vaccine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions..

It is important to receive this vaccine at the proper time. If your child misses a scheduled shot, call your child's doctor to make another appointment as soon as possible.

Precautions While Using This Medicine:

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.

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.

Proquad® injection 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.

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.

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

Fever over 39 °C (102 °F)

Less common

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

rash that looks like chickenpox or measles

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Incidence not known

Agitation

back pain, sudden and severe

bleeding gums

blistering, peeling, loosening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody nose

bloody or black, tarry stools

blurred vision

burning or stinging of the skin

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

chest pain or tightness

confusion

cough or hoarseness

cough producing mucus

diarrhea

difficulty with breathing

difficulty with swallowing

dizziness

drowsiness

fainting

fast heartbeat

general feeling of discomfort or illness

hallucinations

hives

inability to move the arms and legs

inability to speak

irritability

itching, pain, redness, swelling, tenderness, or warmth on the skin

joint or muscle pain

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

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

loss of consciousness

lower back or side pain

mood or mental changes

muscle aches and pains

muscle weakness, sudden and progressing

nausea

noisy breathing

numbness, tingling, pain, or weakness in the hands or feet

pain, numbness, or tingling of the hands, arms, legs, or feet

pain, tenderness, or swelling in the testicles and scrotum

painful blisters on the trunk of the body

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful knees and ankles

painful or difficult urination

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, buttocks, legs, or ankles

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

seizures

severe or sudden headache

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

shivering

skin rash

skin rash on the face, scalp, or stomach

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

stiff neck or back

stomach pain

sudden numbness and weakness in the arms and legs

sweating

swelling or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

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

temporary blindness

tenderness

thickening of bronchial secretions

tingling of the hands or feet

trembling or shaking of the hands or feet

trouble sleeping

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual weight gain or loss

vomiting

warmth on the skin

weakness in the arm or leg on one side of the body, sudden and severe

weakness of the muscles in your face

white patches in the mouth or throat or on the tongue

white patches with diaper rash

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

Incidence not known

Abnormal dreams

blindness

bloated

blue-yellow color blindness

deafness

decreased vision

difficulty with moving

double vision

ear pain

excess air or gas in the stomach or intestines

eye pain

full feeling

irritation and swelling of the eyelids

lack of feeling or emotion

muscle or bone pain

muscle pain or stiffness

nervousness

pain and swelling in the scrotum

pain in the hip, leg, or neck

pain or tenderness around the eyes and cheekbones

passing gas

red rash with watery, yellow-colored, or pus filled blisters

thick yellow to honey-colored crusts

uncaring

unusually deep sleep

unusually long duration of sleep

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.