Rotavirus Vaccine, Live, Oral ROH-ta-vy-ris vak-SEEN

What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: rotavirus vaccine, live, oral, monovalent; Rotarix; rotavirus vaccine, live, oral, pentavalent; RotaTeq

What is this medicine used for?

This vaccine is given by mouth to prevent rotavirus infection. Rotavirus causes severe diarrhea, mostly in babies and young children. Children with the disease often also have vomiting and fever. This vaccine will not protect a child who already has the rotavirus infection.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if your baby has ever had:

• an allergic reaction to other vaccine shots, latex, or any medicine
• a blood disorder or bone marrow disease such as leukemia or lymphoma
• a blood transfusion or treatment with immune globulin
• an intestinal problem such as intussusception or surgery on the abdomen
• a weakened immune system from diseases such as cancer or HIV/AIDS, Severe Combined Immunodeficiency Disease (SCID), or from cancer chemotherapy, radiation therapy, or other medicines

Tell your healthcare provider if your baby has any infection with fever, diarrhea, or vomiting, or has not been gaining weight. Also, tell your healthcare provider if your child has regular close contact with someone who has a weakened immune system.

How do I use it?

This vaccine is given by a healthcare provider. The liquid is squeezed gently into the baby's mouth.

There are two brands of rotavirus vaccine. A baby should get either 2 or 3 doses, depending on which brand is used.

The doses are recommended at these ages:

• First Dose: 2 months of age
• Second Dose: 4 months of age
• Third Dose: 6 months of age (if needed)

The first dose may be given as early as 6 weeks of age, and should be given by age 14 weeks 6 days. The last dose should be given by 8 months of age.

This vaccine may be given at the same time as other routine childhood shots, such as DPT, hepatitis B, and pneumonia vaccines. Other live virus vaccines should be given at least 1 month apart from this vaccine.

What should I watch out for?

Three doses are needed to protect against rotavirus. It is very important that your child receive all of the doses on schedule.

Contact your healthcare provider right away, after any dose of this vaccine, even if it has been several weeks after the last dose of this vaccine, if your child has:

• high fever
• sudden or severe stomach pain
• vomiting
• diarrhea
• blood in the stool or change in bowel movements

These symptoms may be signs of a serious and life-threatening problem.

Blood transfusions or immunoglobulin medicine can block the effect of this vaccine. Your baby should not receive this vaccine within 42 days of a blood transfusion or immunoglobulin injection.

If your child needs emergency care or surgery tell the healthcare provider that your child has received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in the chest; swelling of lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Sudden stomach pain, high fever, behavior changes, severe diarrhea or vomiting; blood or mucus in stools or other changes in bowel movements; rash, red eyes, red mouth, swollen glands, and swollen hands and feet.

Other: Mild, temporary diarrhea or vomiting, mild fever, irritability, fussiness, runny nose, sore throat, wheezing or coughing, ear infection.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. This vaccine may not protect your baby if he or she receives it while taking:

• chemotherapy, radiation therapy, or medicines to treat cancer
• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef), methylprednisolone (Medrol), prednisone, prednisolone (Orapred, and triamcinolone (Aristospan, Kenalog)
• immune globulin
• immunosuppressants such as azathioprine (Imuran), cyclosporine (Sandimmune, Gengraf, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)

Keep a record of all vaccines received and when your child received them.

If you are not sure if medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child’s medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.