with regards to [0.001).:<0.001). Efficacy Through Two Rotavirus Seasons The efficacy of Rotarix persisting through two rotavirus seasons was evaluated in two studies. In the European study, the efficacy of Rotarix against any grade of severity of rotavirus gastroenteritis through two rotavirus seasons was 78.9% (95% CI: 72.7, 83.8). Efficacy in preventing any grade of severity of rotavirus gastroenteritis cases occurring only during the second season post-vaccination was 71.9% (95% CI: 61.2, 79.8). The efficacy of Rotarix against severe rotavirus gastroenteritis through two rotavirus seasons was 90.4% (95% CI: 85.1, 94.1). Efficacy in preventing severe rotavirus gastroenteritis cases occurring only during the second season post-vaccination was 85.6% (95% CI: 75.8, 91.9). The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 96.0% (95% CI: 83.8, 99.5). In the Latin American study, the efficacy of Rotarix against severe rotavirus gastroenteritis through two years was 80.5% (95% CI: 71.3, 87.1). Efficacy in preventing severe rotavirus gastroenteritis cases occurring only during the second year post-vaccination was 79.0% (95% CI: 66.4, 87.4). The efficacy of Rotarix in reducing hospitalizations for rotavirus gastroenteritis through two years was 83.0% (95% CI: 73.1, 89.7). The efficacy of Rotarix beyond the second season post-vaccination was not evaluated. Efficacy Against Specific Rotavirus Types The type-specific efficacy against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types was statistically significant through one year. Additionally, type-specific efficacy against any grade of severity and severe rotavirus gastroenteritis caused by G1P[8], G2P[4], G3P[8], G4P[8], G9P[8], and combined non-G1 (G2, G3, G4, G9) types was statistically significant through two years (Table 6). Table 6. Type-Specific Efficacy of Rotarix Against Any Grade of Severity and Severe Rotavirus Gastroenteritis (According to Protocol) Through One Rotavirus Season Through Two Rotavirus Seasons Number of Cases Number of Cases Rotarix Placebo % Efficacy Rotarix Placebo % Efficacy Type Identified a N = 2,572 N = 1,302 (95% CI) N = 2,572 N = 1,302 (95% CI) ANY GRADE OF SEVERITY G1P[8] 4 46 95.6% b (87.9, 98.8) 18 89 c,d 89.8% b (82.9, 94.2) G2P[4] 3 4 c NS 14 17 c 58.3% b (10.1, 81.0) G3P[8] 1 5 89.9% b (9.5, 99.8) 3 10 84.8% b (41.0, 97.3) G4P[8] 3 13 88.3% b (57.5, 97.9) 6 18 83.1% b (55.6, 94.5) G9P[8] 13 27 75.6% b (51.1, 88.5) 38 71 d 72.9% b (59.3, 82.2) Combined non-G1 (G2, G3, G4, G9, G12) types e 20 49 79.3% b (64.6, 88.4) 62 116 72.9% b (62.9, 80.5) SEVERE G1P[8] 2 28 96.4% b (85.7, 99.6) 4 57 96.4% b (90.4, 99.1) G2P[4] 1 2 c NS 2 7 c 85.5% b (24.0, 98.5) G3P[8] 0 5 100% b (44.8, 100) 1 8 93.7% b (52.8, 99.9) G4P[8] 0 7 100% b (64.9, 100) 1 11 95.4% b (68.3, 99.9) G9P[8] 2 19 94.7% b (77.9, 99.4) 13 44 d 85.0% b (71.7, 92.6) Combined non-G1 (G2, G3, G4, G9, G12) types e 3 33 95.4% b (85.3, 99.1) 17 70 87.7% b (78.9, 93.2) CI = Confidence Interval; NS = Not significant. a Statistical analyses done by G type; if more than one rotavirus type was detected from a rotavirus gastroenteritis episode, the episode was counted in each of the detected rotavirus type categories. b Statistically significant vs. placebo ( P> <0.05). c The P genotype was not typeable for one episode. d P[8] genotype was not detected in one episode. e Two cases of G12P[8] were isolated in the second season (one in each group). REFERENCES Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564 572. Tate JE, Simonsen L, Viboud C, et al. Trends in intussusception hospitalizations among US infants, 1993 2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics 2008;121:e1125-e1132. Centers for Disease Control and Prevention. Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-12):1-13. Parashar UD, Holman RC, Clarke MJ, et al. Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995: surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code. J Infect Dis 1998;177:13-17. Ruuska T, Vesikari T. Rotavirus disease in Finnish children: use of numerical scores for severity of diarrheal episodes. Scand J Infect Dis 1990;22:259-267. How Supplied/Storage and Handling Rotarix is available as a vial of lyophilized vaccine, a prefilled oral applicator of liquid diluent (1 mL) with a plunger stopper, and a transfer adapter for reconstitution. Supplied as: NDC 58160-805-11 (package of 10) Storage Before Reconstitution Vials: Store the vials of lyophilized Rotarix refrigerated at 2 to 8 C (36 to 46 F). Protect vials from light. Diluent: The diluent may be stored at a controlled room temperature 20 to 25 C (68 to 77 F). Do not freeze. Discard if the diluent has been frozen. Storage After Reconstitution Rotarix should be administered within 24 hours of reconstitution. It may be stored refrigerated at 2 to 8 C (36 to 46 F) or at room temperature up to 25 C (77 F), after reconstitution. Discard the reconstituted vaccine if not used within 24 hours in biological waste container. Do not freeze. Discard if the vaccine has been frozen. Patient Counseling Information See FDA-approved patient labeling. Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information. Patient Advice Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with Rotarix, and of the importance of completing the immunization series. The healthcare provider should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with administration of Rotarix or other vaccines containing similar components. The parent or guardian accompanying the recipient should be instructed to report any adverse events to their healthcare provider. The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). Rotarix and PEDIARIX are registered trademarks of GlaxoSmithKline. Manufactured by GlaxoSmithKline Biologicals Rixensart, Belgium, US License 1617 Distributed by GlaxoSmithKline Research Triangle Park, NC 27709 2010, GlaxoSmithKline. All rights reserved. RTX:7PI ------------------------------------------------------------------------------------------------------------- PATIENT INFORMATION Rotarix (ROW-tah-rix) 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: 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 Severe Combined Immunodeficiency Disease (SCID), a severe problem with his/her immune system. Tell your doctor if your baby: 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. 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, especially if symptoms occur in the first 7 days after the first dose, but even if it has been several weeks since the last vaccine dose because these may be signs of a serious problem called intussusception that happens when a part of the intestine gets blocked or twisted: 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). Preliminary data from a study in Mexico suggests an increased risk of intussusception in the first month, but especially in the first 7 days, after the first dose. 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. How is Rotarix given? Rotarix is a liquid that is dropped into your baby s mouth and swallowed. Figure 1. Administration of Rotarix 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 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. Rotarix is a registered trademark of GlaxoSmithKline. Manufactured by GlaxoSmithKline Biologicals Rixensart, Belgium, US License 1617 Distributed by GlaxoSmithKline Research Triangle Park, NC 27709 2010, GlaxoSmithKline. All rights reserved. RTX:5PIL Principal Display Panel NDC 58160-805-11 Rotarix Rotavirus Vaccine, Live, Oral R x only For Oral Use Only Rota Contents (see back panel for storage instructions): 10 Vials of Lyophilized Vaccine 10 Prefilled Oral Dosing Applicators of Diluent 10 Transfer Adapters for Reconstitution STORAGE: Vials: Store lyophilized vaccine refrigerated at 2 o to 8 o C (36 o to 46 o F). Protect vials from light. Diluent: May be stored at room temperature. Do not freeze; discard if frozen. Transfer Adapters: May be stored at room temperature. RECONSTITUTION: Reconstitute only with accompanying diluent (calcium carbonate, sterile water, xanthan). After reconstitution, each dose of Rotarix contains at least 10 6.0 median Cell Culture Infective Dose of live attenuated human rotavirus strain. Rotarix should be administered within 24 hours of reconstitution. It may be stored refrigerated at 2 o to 8 o C (36 o to 46 o F) or at a room temperature up to 25 o C (77 o F), after reconstitution. Discard the reconstituted vaccine if not used within 24 hours. Do not freeze; discard if frozen. For oral use only. Shake well immediately before using. Dosage: For infants, 1 mL oral dose after reconstitution. See complete prescribing information for reconstitution instructions and vaccination schedule. Rotarix is a registered trademark of GlaxoSmithKline. Manufactured by GlaxoSmithKline Biologicals Rixensart, Belgium, US License 1617 Distributed by GlaxoSmithKline Research Triangle Park, NC 27709 2008, GlaxoSmithKline Rotarix rotavirus vaccine, live, oral kit Product Information Product Type VACCINE Item Code (Source) NDC:58160-805 Packaging # Item Code Package Description 1 NDC:58160-805-11 1 KIT (KIT) in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 10 VIAL 10 mL Part 2 10 APPLICATOR 10 mL Part 1 of 2 Rotarix rotavirus vaccine, live, oral powder, for solution Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ROTAVIRUS G1 P(8) LIVE ANTIGEN, A (ROTAVIRUS ANTIGEN) ROTAVIRUS G1 P(8) LIVE ANTIGEN, A 1000000 [CCID_50] in 1 mL Inactive Ingredients Ingredient Name Strength DEXTRAN 1 SORBITOL SUCROSE SODIUM CHLORIDE POTASSIUM CHLORIDE MAGNESIUM STEARATE FERRIC NITRATE SODIUM PHOSPHATE SODIUM PYRUVATE DEXTROSE CYSTINE TYROSINE GLUTAMINE CALCIUM CHLORIDE PHENOLSULFONPHTHALEIN Packaging # Item Code Package Description 1 1 mL in 1 VIAL Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125265 08/01/2008 Part 2 of 2 DILUENT water solution Product Information Route of Administration ORAL DEA Schedule Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE WATER XANTHAN GUM Packaging # Item Code Package Description 1 1 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125265 08/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA125265 08/01/2008 Labeler - GlaxoSmithKline Biologicals SA (372748392) Revised: 09/2010 GlaxoSmithKline Biologicals SA Next Interactions Print this page Add to My Med List More about Rotarix (rotavirus vaccine) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: viral vaccines Consumer resources Rotarix Rotarix (Advanced Reading) Professional resources Rotavirus Vaccine Live Oral (AHFS Monograph) Other brands: RotaTeq Related treatment guides Gastroenteritis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer GlaxoSmithKline Drug Class Viral vaccines Related Drugs viral vaccines Zostavax , Fluzone , Fluvirin , Afluria , Fluzone High-Dose , zoster vaccine live Gastroenteritis doxycycline , ceftriaxone , Rocephin , ampicillin , Vibramycin , Monodox , Doryx , Vibra-Tabs , Doryx MPC , Morgidox , RotaTeq , Principen , Omnipen-N , rotavirus vaccine , More... 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