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Generic Name: rotavirus oral vaccine live (ROE-ta-VI-russ)
Brand Name: Rotarix

Rotarix is used for:

Preventing certain types of rotavirus infection in infants and children.

Rotarix is a live viral vaccine for rotavirus. It works by helping the immune system to protect against rotavirus.

Do NOT use Rotarix if:

  • the patient is allergic to any ingredient in Rotarix or to latex rubber
  • the patients has a birth defect of the stomach or bowel (eg, Meckel diverticulum) that has not been corrected by surgery
  • the patient has severe combined immunodeficiency disease (SCID)
  • the patient has a history of a severe type of blockage or twisting of the intestine (intussusception)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rotarix:

Some medical conditions may interact with Rotarix. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if the patient is pregnant, planning to become pregnant, or is breast-feeding
  • if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if the patient has allergies to medicines, foods, or other substances (eg, latex)
  • if the patient has any type of cancer (eg, leukemia, lymphoma), infection, fever, or other current illness (eg, diarrhea, vomiting)
  • if the patient or someone regularly in close contact with the patient has a history of a weakened immune system (eg, HIV infection, AIDS)
  • if the patient or someone regularly in close contact with the patient is being treated for cancer or takes medicine that may weaken the immune system, including an immunosuppressant (eg, cyclosporine) or a corticosteroid (eg, prednisone)
  • if the patient has stomach or bowel problems (eg, blockage), chronic diarrhea, a birth defect, or has had stomach or bowel surgery
  • if the patient has not been gaining weight or growing as expected
  • if the patient has had a recent blood or plasma transfusion, or has received immune globulin
  • if the patient has been exposed to the rotavirus before receiving Rotarix

Some MEDICINES MAY INTERACT with Rotarix. Tell your health care provider if the patient is taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone), immunosuppressants (eg, cyclosporine), or medicines to treat cancer because they may decrease Rotarix's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rotarix may interact with other medicines that the patient takes. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rotarix:

Use Rotarix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Rotarix. Talk to your pharmacist if you have questions about this information.
  • Rotarix is usually given by mouth at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about Rotarix.
  • Rotarix requires 2 doses. If you miss a dose of Rotarix, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Rotarix.

Important safety information:

  • The risk of a severe type of blockage or twisting of the intestine (intussusception) may be increased in infants and children after taking Rotarix. If this occurs, most cases have happened within 7 days after the first dose. However, this can occur up to several weeks after the last dose. Seek medical attention right away if your child develops blood in the stool, high fever, severe or persistent diarrhea or vomiting, or severe stomach pain.
  • It is important to follow the recommended immunization schedule in order for Rotarix to be effective. Discuss any questions or concerns with your child's doctor.
  • Rotarix should be used with extreme caution in CHILDREN younger than 6 weeks or older than 24 weeks; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if Rotarix can cause harm to the fetus. It is not known if this medicine is found in breast milk. Rotarix is not approved for use in patients of childbearing age.

Possible side effects of Rotarix:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; decreased appetite; fussiness; increased crying or irritability; mild fever or vomiting; runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; change in bowel movements; high fever; red eyes or mouth; severe or persistent crying; severe or persistent diarrhea, stomach pain, or vomiting; swelling of the hands or feet; swollen glands; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Rotarix:

Rotarix is usually handled and stored by a health care provider. If you are using Rotarix at home, store Rotarix as directed by your pharmacist or health care provider. Protect from light. Keep Rotarix out of the reach of children and away from pets.

General information:

  • If you have any questions about Rotarix, please talk with your doctor, pharmacist, or other health care provider.
  • Rotarix is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Rotarix or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Rotarix. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rotarix. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Rotarix.

Issue Date: June 3, 2015