How does this medication work? What will it do for me?

Rotavirus vaccine is used to prevent infection by the rotavirus, which causes severe gastrointestinal (digestive system) infections in newborns and young children. The vaccine is made up of live virus that has been weakened so that it does not cause infection. The vaccine works by exposing your body to the weakened virus, thus allowing your body to produce its own protection (antibodies) against the disease.

Rotavirus is the most common cause of severe diarrhea in newborns and young children. It is spread from hand-to-mouth contact with stools from an infected person. Although most children get over this infection on their own, some develop severe vomiting, diarrhea and dehydration, needing hospital care to recover.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each 1.5 mL dose of clear, colourless liquid, free of visible particles, contains not less than 106.0 CCID50 of human rotavirus RIX4414 strain (live, attenuated), produced on Vero cells. Nonmedicinal ingredients: Dulbecco's Modified Eagle Medium (DMEM), sucrose, di-sodium adipate and sterile water. Residues: Porcine Circovirus type 1 (PCV-1) material has been detected in ROTARIX®. Applicator stopper contains butyl rubber.

How should I use this medication?

Rotarix® is given by mouth in 2 doses. The first dose should be given after the baby is at least 6 weeks old. The second dose should be given at least 4 weeks later. Both doses should be given before the baby is 24 weeks old, but preferably by 16 weeks of age.

Rotavirus vaccine is provided as a single, pre-measured dose which can be opened and given directly into the baby's mouth. This medication should not be mixed with any food or drink.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important this medication be given exactly as recommended by your doctor. If you miss an appointment for your child to receive rotavirus vaccine, contact your doctor as soon as possible to reschedule your appointment.

Store this medication in the refrigerator, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not give the rotavirus vaccine to someone who:

  • is allergic to rotavirus vaccine or any ingredients of the medication
  • has severe combined immunodeficiency disorder (SCID)
  • has a history of intussusception (a condition where part of the intestine is pulled into itself)
  • has a medical condition that may make intussusceptions more likely to occur

This vaccine is intended for children only and should not be taken by adults.

Do not give this medication to infants under 6 weeks of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • gas
  • irritability
  • skin irritation

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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

  • abdominal pain
  • blood in the stools

Seek immediate medical attention if any of the following occur:

  • signs of blocked intestine (e.g., severe stomach pain, vomiting, blood in stools, swollen belly, high fever)
  • signs of a serious allergic reaction (shortness of breath; wheezing; trouble breathing; hives; swelling of the lips, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Fever: Your child's doctor may decide to delay this vaccine if your child has an acute infection or fever. Mild infections without fever, such as colds, usually do not require delay of the vaccine.

Immune problems: As with any vaccine, rotavirus vaccine may not provide complete protection against rotavirus for all people. When used for children with impaired immune systems, rotavirus vaccine may not create enough of an antibody response to protect against infections caused by these bacteria. Also, this vaccine may not be effective for people receiving immunosuppressive therapy (e.g., some medications used to treat cancer or for transplant recipients).

Other vaccines: Rotavirus vaccine may be given in the doctor's office at the same time as your child receives other routine infant vaccinations.

Pregnancy: This vaccine is intended for infants and young children only and should not be used by pregnant women.

Breast-feeding: This vaccine is intended for infants and young children only and should not be used by breast-feeding women.

What other drugs could interact with this medication?

There may be an interaction between rotavirus vaccine and any of the following:

  • acetaminophen
  • immune globulin
  • immunosuppressants
    • azathioprine
    • belimumab
    • corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
    • cyclosporine
    • fingolimod
    • golimumab
    • hydroxychloroquine
    • leflunomide
    • infliximab
    • medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
    • rituximab
    • tacrolimus
  • tuberculin skin tests

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.