Rotavirus Vaccine Oral Solution (Rotarix)

What is this medication?

ROTAVIRUS VACCINE (ROH tuh vahy ruhs vak SEEN) reduces the risk of rotavirus. It does not treat rotavirus. It is still possible to get rotavirus after receiving this vaccine, but the symptoms may be less severe or not last as long. It works by helping your immune system learn how to fight off a future infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rotarix

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood disorder
• Cancer
• Diarrhea or vomiting
• Fever or infection
• Growth problems
• History of stomach or intestine problems
• Immune system problems in infant or household member
• An unusual or allergic reaction to vaccines, latex, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This vaccine is given by mouth. It is given by your care team.

A copy of Vaccine Information Statements will be given before each vaccination. Be sure to read this information carefully each time. This sheet may change often.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 weeks old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Adalimumab
• Anakinra
• Certolizumab
• Etanercept
• Infliximab
• Medications that lower your chance of fighting an infection
• Medications to treat cancer

This medication may also interact with the following:

• Immunoglobulins
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Report any side effects to your care team.

This vaccine, like all vaccines, may not fully protect everyone.

It may be possible to pass the rotavirus to others. Talk to your care team if the infant has close contact with people who are sick or have immune system problems.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Severe or prolonged diarrhea

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Fever
• Irritability
• Poor feeding
• Runny or stuffy nose
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.