Rotarix
Generic Name: Rotavirus Vaccine, live, oral
Date of Approval: April 3, 2008
Company: GlaxoSmithKline Biologicals
Treatment for: Prevention of Rotavirus Gastroenteritis
FDA Approves Rotarix
The U.S. Food and Drug Administration (FDA) has approved Rotarix [Rotavirus Vaccine, live, oral] for the prevention of rotavirus gastroenteritis in infants.
Rotarix will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Since rotavirus disproportionately affects young children -- severe rotavirus diarrhea and dehydration can occur as young as three months of age -- Rotarix could help prevent many of the 55,000-70,000 hospitalizations by young children that result from rotavirus in the U.S. each year.
Not only does Rotarix confer protection at an early age, but clinical trials have shown that protection is broad and sustained. Rotarix is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series of Rotarix show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, Rotarix was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S.
The FDA's approval of Rotarix was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
The CDC Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that infants receive routine rotavirus vaccination in order to prevent rotavirus gastroenteritis. Rotarix will be commercially available in the U.S. in the second half of 2008.
About Rotarix
Rotarix is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of Rotarix have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five phase III clinical trials were conducted worldwide to assess the safety and efficacy of Rotarix in support of U.S. licensure. The biological license application for Rotarix is based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. Rotarix is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract.
About Rotavirus
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency department visits. In addition, between 55,000 and 70,000 children are hospitalized and 20 to 60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November-December and spreads to the northeast by April-May.
Rotarix Patient Information
Rotavirus Vaccine, Live, Oral
Read this Patient Information carefully before your baby gets Rotarix and before your baby receives the next dose of Rotarix. This leaflet is a summary of information about Rotarix and does not take the place of talking with your baby’s doctor.
What is Rotarix?
Rotarix is a vaccine that protects your baby from a kind of virus (called a rotavirus) that can cause bad diarrhea and vomiting. Rotavirus can cause diarrhea and vomiting that is so bad that your baby can lose too much body fluid and need to go to the hospital. Rotavirus vaccine is a liquid that is given to your baby by mouth. It is not a shot.
Who should not take Rotarix?
Your baby should not get Rotarix if a doctor has told you that your baby’s digestive system has a defect (is not normal).
Tell your doctor if your baby:
- Has had an allergic reaction to the last dose of Rotarix.
- Is allergic to any ingredient of Rotarix or to latex.
- Has problems with his/her immune system.
- Has cancer.
- Will be in close contact with someone who has problems with his/her immune system or is getting treated for cancer.
If your baby has been having diarrhea and vomiting, your doctor may want to wait before giving your baby a dose of Rotarix.
Call your child’s doctor right away if your child has vomiting, diarrhea, severe stomach pain, severe crying, blood in their stool or change in his/her bowel movements as these may be signs of a serious problem called intussusception. It is important to contact your doctor if you have questions or if your child has any of these symptoms, even if it has been several weeks since the last vaccine dose.
How is Rotarix given?
Rotarix is a liquid that is dropped into your baby’s mouth and swallowed.
Your baby will get the first dose at around 6 weeks old.
The second dose will be at least 4 weeks after the first dose (before 6 months old).
Be sure to plan the time for your baby’s second dose with the doctor because it is important that your baby gets both doses of Rotarix before your baby is 6 months old. The doctor may decide to give your baby shots at the same time as Rotarix.
Your baby can be fed normally after getting Rotarix.
What are possible side effects of Rotarix?
The most common side effects of Rotarix are:
- Crying
- Fussy
- Cough
- Runny nose
- Fever
- Loss of appetite
- Vomiting.
Call your doctor right away or go to the emergency department if your baby has any of these problems after getting Rotarix because these may be signs of a serious problem:
- Bad vomiting
- Bad diarrhea
- Bloody bowel movement
- High fever
- Severe stomach pain (if your baby brings his/her knees to his/her chest while crying or screaming).
Talk to your baby’s doctor if your baby has any other problems that concern you.
What are the ingredients in Rotarix?
Rotarix contains weakened human rotavirus. Rotarix also contains dextran, sorbitol, xanthan, and Dulbecco’s Modified Eagle Medium (DMEM). The ingredients of DMEM are as follows: sodium chloride, potassium chloride, magnesium sulphate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. Rotarix contains no preservatives. The dropper used to give your baby Rotarix contains latex.
For more information, please see Rotarix Product Label
| Link to this page |  |
Printable Version |  |
Email Page |  |
Add to my drug list |
