Rotavirus Vaccine, Live, Pentavalent (ROE-ta-vye-rus VAX-een lyve, pen-ta-VAY-lent)

Prevents infants and children from getting rotavirus stomach infection.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• A nurse or other trained health professional will give your child this vaccine. It is given by mouth.
• Your child should receive 3 doses of this vaccine. The first dose should be given at 6 to 12 weeks of age. The second dose should be given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last dose should be given to your child by 32 weeks of age.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

If a dose is missed:

• This vaccine needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child's doctor for another appointment.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if your child is receiving a treatment that may weaken the immune system. This may include radiation therapy, steroid medicine (such as cortisone, dexamethasone, prednisone, Cortef®, or Medrol®), or medicines to treat cancer (such as cyclophosphamide, doxorubicin, etoposide, Adriamycin®, Cycloblastin®, Cytoxan®, or Etopophos®). This vaccine may not work as well if your child is also using these medicines. Your doctor may still want your child to get the vaccine because it can give your child some protection.
• Tell you child's doctor if your child has received a blood transfusion or blood products (including immunoglobulins) within the past 42 days.

Warnings While Using This Medicine:

• Tell your child's doctor if your child had any previous vaccinations, a blood transfusion, has a fever, chronic diarrhea, a blood disease, or any type of cancer. Tell your child's doctor if your child has had an abdominal or stomach surgery, was born with digestive problems, or has an active stomach illness. Your child's doctor should also know if your child has not been gaining weight, is not growing as expected, or has a weak immune system because of a disease (such as HIV or AIDS) or a medicine (such as steroids).
• Tell your child's doctor if your child spends time with a person who has immune system problems or is getting cancer treatment. Your doctor may recommend ways (e.g., proper hand washing after changing of diapers) to help prevent the spread of vaccine virus.
• Call your child's doctor right away if your child has diarrhea, blood in their stool, a high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.
• If your child is very sick and has a high fever, your child will probably need to wait until he or she is well before receiving the vaccine.
• This vaccine may not protect all children who are receiving it against rotavirus stomach infection.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever.
• Pain on urination, or a change in how much or how often your child urinates.
• Problems with hearing, or fluid draining from the ear.
• Rash, red eyes or mouth, swollen glands, or swollen hands and feet.
• Runny or stuffy nose, cough, sore throat, or trouble breathing.
• Seizures.
• Sudden stomach pain, red or black stools, or changes in your child's bowel movements.
• Trouble breathing.

If you notice these less serious side effects, talk with your doctor:

• Crying, fussiness, or irritability.
• Diarrhea, nausea, vomiting, or upset stomach.
• Loss of appetite.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088