Wednesday, October 12, 2016

measles, mumps, rubella, and varicella virus vaccine live Subcutaneous


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


Commonly used brand name(s)

In the U.S.


  • ProQuad

Available Dosage Forms:


  • Powder for Solution

  • Powder for Suspension

Therapeutic Class: Vaccine


Uses For measles, mumps, rubella, and varicella virus vaccine live


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 these diseases.


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 sometimes it can cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease called Reye's syndrome.


Immunization against measles, mumps, german measles, and chickenpox is recommended for children 12 months to 12 years of age who has not had these diseases. Immunization against these diseases is not recommended for infants younger than 12 months of age and for children 13 years of age and older.


This vaccine is to be administered only by or under the supervision of your child’s doctor or other authorized healthcare professional.


Before Using measles, mumps, rubella, and varicella virus vaccine live


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 measles, mumps, rubella, and varicella virus vaccine live 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.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of measles, mumps, rubella, and varicella virus vaccine in children 12 months to 12 years of age. However, this vaccine is not recommended for infants younger than 12 months of age and for children 13 years of age and older.


Geriatric


This vaccine is not recommended for use in adult patients.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.


Interactions with 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 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.


  • Aclarubicin

  • Acyclovir

  • Adalimumab

  • Aldesleukin

  • Alemtuzumab

  • Altretamine

  • Amonafide

  • Amsacrine

  • Asparaginase

  • Aspirin

  • Azacitidine

  • Azathioprine

  • Benorilate

  • Bleomycin

  • Broxuridine

  • Busulfan

  • Capecitabine

  • Carboplatin

  • Carmustine

  • Certolizumab Pegol

  • Chlorambucil

  • Choline Magnesium Trisalicylate

  • Cisplatin

  • Cladribine

  • Cyclophosphamide

  • Cytarabine

  • Cytarabine Liposome

  • Dacarbazine

  • Dactinomycin

  • Daunorubicin

  • Daunorubicin Citrate Liposome

  • Decitabine

  • Docetaxel

  • Doxifluridine

  • Doxorubicin Hydrochloride

  • Doxorubicin Hydrochloride Liposome

  • Edatrexate

  • Eflornithine

  • Epirubicin

  • Estramustine

  • Etanercept

  • Etoposide

  • Everolimus

  • Fingolimod

  • Floxuridine

  • Fludarabine

  • Fluorouracil

  • Fotemustine

  • Gallium Nitrate

  • Gemcitabine

  • Golimumab

  • Hydroxyurea

  • Idarubicin

  • Ifosfamide

  • Irinotecan

  • Lomustine

  • Mechlorethamine

  • Melphalan

  • Meningococcal Vaccine

  • Mercaptopurine

  • Mesalamine

  • Methotrexate

  • Mitolactol

  • Mitomycin

  • Mitotane

  • Mitoxantrone

  • Mycophenolic Acid

  • Olsalazine

  • Oxaliplatin

  • Paclitaxel

  • Pegaspargase

  • Pentostatin

  • Pipobroman

  • Pirarubicin

  • Plicamycin

  • Pneumococcal Vaccine Polyvalent

  • Procarbazine

  • Raltitrexed

  • Rilonacept

  • Rituximab

  • Salicylamide

  • Salicylic Acid

  • Salsalate

  • Sirolimus

  • Sodium Salicylate

  • Sodium Thiosalicylate

  • Streptozocin

  • Tacrolimus

  • Teceleukin

  • Tegafur

  • Temsirolimus

  • Teniposide

  • Thioguanine

  • Thiotepa

  • Topotecan

  • Treosulfan

  • Trimetrexate

  • Trofosfamide

  • Trolamine Salicylate

  • Uracil Mustard

  • Ustekinumab

  • Vinblastine

  • Vincristine

  • Vincristine Liposome

  • Vindesine

  • Vinorelbine

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

  • Leflunomide

Interactions with Food/Tobacco/Alcohol


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:


  • Blood disorder (weak immune system) or

  • Bone marrow cancer or

  • Immune deficiency condition, or family history of or

  • Illness with a fever or

  • Leukemia (cancer of the blood) or

  • Lymphoma (cancer of the immune system) or

  • Receiving immunosuppressive therapy or

  • Tuberculosis, active and untreated—Should not be used in patients with these conditions.

  • 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.

Proper Use of measles, mumps, rubella, and varicella virus vaccine live


A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot under your skin (usually in the upper arms or thighs).


Your child should receive one shot of the vaccine at 12 to 15 months of age and possibly a second shot 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.


You should receive a patient information sheet about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.


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 measles, mumps, rubella, and varicella virus vaccine live


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. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.


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 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.


measles, mumps, rubella, and varicella virus vaccine live Side Effects


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 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

  • nasal congestion

  • rash that looks like chickenpox or measles

  • runny nose

  • sneezing

  • sore throat

  • unusual tiredness or weakness

Incidence not known
  • Agitation

  • back pain, sudden and severe

  • bleeding gums

  • blistering, peeling, or 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

  • coma

  • 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

  • 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

  • shortness of breath

  • 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 or painful glands

  • 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

  • tightness in the chest

  • 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

  • wheezing

  • 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.



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More measles, mumps, rubella, and varicella virus vaccine live Subcutaneous resources


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