WARNINGS
Who should not take ROTARIX?
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 in the section ADDITIONAL INFORMATION below.
• 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.
Tell your doctor if your baby:
• is allergic 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, as the spread of vaccine virus to non-vaccinated contacts could occur.
Hand washing is recommended after diaper changes to help prevent the spread of vaccine virus. If your baby has been having diarrhea and vomiting, your doctor may want to wait before giving your baby a dose of ROTARIX.
USES
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.
HOW TO USE
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
• fussiness
• 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, even if it has been several weeks since the last vaccine dose because these may be signs of a serious problem called intussusception:
• 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. Since FDA approval, reports of infants with intussusception have been received by Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some infants needed hospitalization, surgery on their intestines, or a special enema to treat this problem. Death due to intussusception has occurred. 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). Talk to your baby’s doctor if your baby has any 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. 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.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
ROTARIX is available in single-dose vials of lyophilized vaccine, accompanied by a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution.
Supplied as an outer package of 10 doses (NDC 58160-854-52) containing:
NDC 58160-851-01 vial of lyophilized vaccine in package of 10: NDC 58160-851-10 NDC 58160-853-02 oral applicator of diluent (10 applicators)
Storage before Reconstitution
Lyophilized vaccine in vials: Store refrigerated at 2-degrees to 8-degrees C (36-degrees to 46-degrees F). Protect vials from light.
Diluent in oral applicators: Store refrigerated at 2-degrees to 8-degrees C (36-degrees to 46-degrees F) or at a controlled room temperature up to 25-degrees C (77-degrees 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-degrees to 8-degrees C (36-degrees to 46-degrees F) or at a controlled room temperature up to 25-degrees C (77-degrees 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.
NOTES
Medication Guide: revision date 11/2022
Prescribing Information: revision date: 01/2024
DRUG INTERACTIONS
1. Concomitant Vaccine Administration
In clinical trials, ROTARIX was administered concomitantly with U.S.-licensed and non–U.S.-licensed vaccines. In a U.S. coadministration study in 484 infants, there was no evidence of interference in the immune responses to any of the antigens when PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], a U.S.-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.), and a U.S.-licensed Hib conjugate vaccine (Sanofi Pasteur SA) were coadministered with ROTARIX as compared with separate administration of ROTARIX.
2. Immunosuppressive Therapies
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to ROTARIX. See the section WARNINGS above.
See the section WARNINGS above.
