Meruvax II (Subcutaneous)

Rubella virus vaccine live is a vaccine used to help protect against rubella virus infection. It works by helping your body create its own defense (antibodies) against the virus.

Rubella, also known as German measles, can lead to serious problems like miscarriages, stillbirths, or birth defects in unborn babies if pregnant women get infected. While it's recommended for everyone to get vaccinated against rubella, it is particularly important for women who could become pregnant.

Getting vaccinated against rubella is also important for people working in medical settings, teenagers, adult men, travelers going outside the U.S., and all children aged 12 months and older, including school-aged kids.

Vaccination against rubella is not advised for infants younger than 12 months because the antibodies they got from their mothers before birth may reduce the vaccine's effectiveness. Children who received the rubella vaccine before they turned 12 months should be vaccinated again.

You can be considered immune to rubella only if you received the rubella vaccine on or after your first birthday and have proof from your medical records, or if you have had a blood test that shows you are immune. Having had a rubella infection in the past does not guarantee immunity, as the symptoms of rubella are not reliable enough to confirm that you had the disease.

Since the rubella vaccine may not protect everyone, you might want to ask your doctor to check your immunity to the rubella virus 6 to 8 weeks after your vaccination. This is especially important if you are a woman of child-bearing age who may become pregnant in the future.

This vaccine should only be given by or under the guidance of your doctor or another healthcare professional.

Do not become pregnant for 3 months after receiving the rubella vaccine without first checking with your doctor. There is a chance that this vaccine may cause birth defects.

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 blood transfusions or other blood products within 2 weeks after receiving this vaccine.
• if you are to receive gamma globulin or other immune globulins within 2 weeks after receiving this vaccine.

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the benefits. This is a decision you and your doctor will make together. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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

This vaccine is not recommended for infants under 12 months of age. It has been tested in older infants and children, and in effective doses, it has not been shown to cause different side effects or problems compared to adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose, or other precautions may be necessary. When you receive this vaccine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on 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 against using 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 necessary 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
• Bimekizumab-bkzx
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Etrasimod
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Mirikizumab-mrkz
• 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
• Vamorolone
• Voclosporin

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both medications 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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Immune deficiency condition (or family history of)—This condition may increase the chance and severity of side effects from the vaccine and/or may decrease the benefits of the vaccine.

• Severe illness with fever—The symptoms of this condition may be mistaken for the possible side effects of the vaccine.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• convulsions (seizures)
• headache (severe or continuing)
• pain, numbness, or tingling of hands, arms, legs, or feet
• stiff neck
• unusual irritability
• 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. Your health care professional may also 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, 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), sore throat, runny nose, or fever
• itching, swelling, redness, tenderness, or hard lump at place of injection
• nausea
• vague feeling of bodily discomfort

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

Some of the above side effects may not occur until 1 to 4 weeks after immunization and usually last less than 1 week. Aches or pain in joints may not occur until 1 to 10 weeks after immunization and usually last less than 1 week. Check with your doctor if this side effect continues or is bothersome.

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.

In the U.S.

• Meruvax II

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: 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.