Description

    Rubella and mumps virus vaccine live is an active immunizing agent used to prevent infection by the rubella and mumps viruses. It works by causing your body to produce its own protection (antibodies) against the virus.

    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.

    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 in women during the first 3 months of pregnancy.

    While immunization against rubella and mumps is recommended for all persons 12 months of age and older, it is especially important for women of childbearing age and persons traveling outside the U.S.

    If rubella and mumps virus vaccine live is to be given to a child, the child should be at least 12 months of age. This is to make sure the vaccine is effective. In a child less than 12 months of age, antibodies from the mother may prevent the vaccine from working.

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


    Before Using

    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.

    Pediatric

    Use of this vaccine is not recommended for infants younger than 12 months of age. Children who received the vaccine when younger than 12 months of age should receive another dose of vaccine at 12 to 15 months of age.

    Breastfeeding

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

    Drug Interactions

    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

    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
    • Atidarsagene Autotemcel
    • Atoltivimab
    • Axicabtagene Ciloleucel
    • Azathioprine
    • Baricitinib
    • Belatacept
    • Betibeglogene Autotemcel
    • Bimekizumab-bkzx
    • Brexucabtagene Autoleucel
    • Brodalumab
    • Canakinumab
    • Certolizumab Pegol
    • Cyclosporine
    • Deucravacitinib
    • Deuruxolitinib
    • Dupilumab
    • Efgartigimod Alfa-fcab
    • Elivaldogene Autotemcel
    • Emapalumab-lzsg
    • Etanercept
    • Etrasimod
    • Everolimus
    • Fidanacogene Elaparvovec-dzkt
    • Fingolimod
    • Golimumab
    • Guselkumab
    • Hyaluronidase
    • Immune Globulin
    • Inebilizumab-cdon
    • Infliximab
    • Ixekizumab
    • Leflunomide
    • Leniolisib
    • Lovotibeglogene Autotemcel
    • Mirikizumab-mrkz
    • Mycophenolate Mofetil

    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:

    • Immune deficiency condition (or family history of)—Condition may increase the chance and severity of side effects of the vaccine and/or may decrease the useful effects of the vaccine
    • Severe illness with fever—The symptoms of the condition may be confused with the possible side effects of the vaccine

    Proper Use

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For injection dosage form:
      • For prevention of rubella and mumps:
        • Adults and children 12 months of age and older—One dose injected under the skin.
        • Children up to 12 months of age—Use is not recommended.

    Precautions

    Do not become pregnant for 3 months after receiving rubella and mumps virus vaccine live without first checking with your doctor . There may be a chance that this vaccine can cause birth defects.

    Tell your doctor that you have received this vaccine:

    • If you are to receive blood products or immune globulins within 14 days of receiving this vaccine
    • If you are to receive this vaccine within 3 months of receiving blood products or immune globulin
    • 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.

    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:

    Symptoms of allergic reaction

    • Difficulty in breathing or swallowing
    • hives
    • itching, especially of feet or hands
    • reddening of skin, especially around ears
    • swelling of eyes, face, or inside of nose
    • unusual tiredness or weakness (sudden and severe)

    Check with your doctor as soon as possible if any of the following side effects occur:

    Less common

    • Pain or tenderness of eyes

    Rare

    • Bruising or purple spots on skin
    • confusion
    • fever over 103 °F (39.4 °C)
    • headache (severe or continuing)
    • irritability
    • pain, numbness, or tingling of hands, arms, legs, or feet
    • pain, tenderness, or swelling in testicles and scrotum
    • stiff neck
    • vomiting

    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

    • Burning or stinging at place of injection
    • skin rash
    • swelling of glands in neck

    Less common

    • Aches or pain in joints
    • headache (mild)
    • itching, swelling, redness, tenderness, or hard lump at place of injection
    • nausea
    • runny nose
    • sore throat
    • vague feeling of bodily discomfort

    The above side effects (especially aches or pain in joints) are more likely to occur in adults, particularly women.

    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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