Rotarix

What is Rotarix?

• Rotarix (rotavirus vaccine, live, oral) is a vaccine used for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9).

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Rotarix

What are the uses of this medicine?

• Rotarix (rotavirus vaccine, live, oral) 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.
• ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

How does this medicine work?

• The exact immunologic mechanism by which ROTARIX protects against rotavirus gastroenteritis is unknown.
• ROTARIX contains a live, attenuated human rotavirus that replicates in the small intestine and induces immunity.

Who Should Not Use this medicine ?

Your baby should not get ROTARIX if:

• he or she has had an allergic reaction after getting a dose of ROTARIX.
• he or she is allergic to any of the ingredients of this vaccine. A list of ingredients can be found at the end of this leaflet.
• a doctor has told you that your baby’s digestive system has a defect (is not normal).
• he or she has a history of a serious problem called intussusception that happens when a part of the intestine gets blocked or twisted.
• he or she has Severe Combined Immunodeficiency Disease (SCID), a severe problem with his/her immune system.

What drug interactions can this medicine cause?

• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to ROTARIX.

Is this medicine FDA approved?

• It was approved in Europe in 2006 and by the U.S. FDA in April 2008.

How should this medicine be used?

Recommended dosage:

• Each dose is 1 mL administered orally.
• Administer first dose to infants beginning at 6 weeks of age.
• Administer second dose after an interval of at least 4 weeks and up to 24 weeks of age.

Administration:

• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Vial of lyophilized vaccine to be reconstituted with a liquid diluent in a prefilled oral applicator.
• Each 1-mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P[8] rotavirus after reconstitution.

This medicine is available in fallowing brand namesː

• ROTARIX

What side effects can this medication cause?

The most common side effects of this medicine include:

• crying
• fussiness
• cough
• runny nose
• fever
• loss of appetite
• vomiting

ROTARIX can cause serious side effects, including:

• 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).

• Studies showed an increased risk of intussusception after the first and second dose of vaccine, especially in the first 7 days.

Other reported side effects include:

• Kawasaki disease (a serious condition that can affect the heart; symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet, and, if not treated, death can occur).

What special precautions should I follow?

• The tip caps of the prefilled oral applicators of diluent contain natural rubber latex which may cause allergic reactions.
• Administration of ROTARIX in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness of ROTARIX in infants with chronic gastrointestinal disorders have not been evaluated.
• Rotavirus shedding in stool occurs after vaccination with peak excretion occurring around Day 7 after Dose 1.Caution is advised when considering whether to administer ROTARIX to individuals with immunodeficient close contacts, such as individuals with malignancies, primary immunodeficiency or receiving immunosuppressive therapy.
• In a postmarketing study, cases of intussusception were observed in temporal association within 31 days following the first dose of ROTARIX, with a clustering of cases in the first 7 days.
• Safety and effectiveness of ROTARIX when administered after exposure to rotavirus have not been evaluated.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• ROTARIX is not intended to use in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of ROTARIX in infants younger than 6 weeks or older than 24 weeks of age have not been evaluated.

What are the active and inactive ingredients in this medicine?

• 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.
• Porcine circovirus type 1 (PCV-1), a virus found in pigs, is present in ROTARIX. PCV-1 is not known to cause disease in humans.
• ROTARIX contains no preservatives.
• The dropper used to give your baby ROTARIX contains latex.

Who manufactures and distributes this medicine?

• Manufactured by GlaxoSmithKline Biologicals
• Rixensart, Belgium.

• Distributed by GlaxoSmithKline
• Research Triangle Park, NC.

What should I know about storage and disposal of this medication?

Storage before Reconstitution:

• Lyophilized vaccine in vials: Store refrigerated at 2° to 8°C (36° to 46°F). Protect vials from light.
• Diluent in oral applicators: Store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F).
• Do not freeze.
• Discard if the diluent has been frozen.

Storage after Reconstitution:

• ROTARIX should be administered within 24 hours of reconstitution.
• After reconstitution, store refrigerated at 2° to 8°C (36° to 46°F) or at a controlled room temperature up to 25°C (77°F).
• Discard the reconstituted vaccine in biological waste container if not used within 24 hours.
• Do not freeze.
• Discard if the reconstituted vaccine has been frozen.

• Dailymed label info on Rotarix
• FDA Rotarix

Rotarix Resources
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