Rotarix

Name: Rotarix

Rotarix and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Rotarix falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Rotarix should only be given to a pregnant woman if clearly needed.

Rotarix Usage

Use Rotarix exactly as prescribed.

Rotarix comes in liquid form to be administered orally by a healthcare professional.

What is the most important information I should know about rotavirus oral vaccine?

Your child should not receive this vaccine if he or she has severe combined immunodeficiency disease (SCID). This vaccine should not be given if the child has a history of an intestinal problem called intussusception (in-tuh-suh-SEP-shun).

How is rotavirus oral vaccine given?

Your child will receive this vaccine in a clinic, hospital, or doctor's office. The rotavirus oral vaccine is given as an oral (by mouth) liquid.

The RotaTeq brand of rotavirus oral vaccine is given in a series of 3 doses. The first dose is usually given when the child is 6 to 12 weeks old. The booster doses are then given at 4-week to 10-week intervals before the child reaches 32 weeks of age.

The Rotarix brand of rotavirus oral vaccine is given in a series of 2 doses. The first dose is usually given when the child is 6 weeks old. The second dose is then given at least 4 weeks after the first dose, but before the child reaches 24 weeks of age.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Tell your doctor if your child spits up or vomits within 1 or 2 hours after receiving rotavirus oral vaccine. The child may need to receive a replacement dose to be fully protected from rotavirus.

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Before Using Rotarix

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of live rotavirus vaccine in infants younger than 6 weeks of age or older than 24 weeks of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of live rotavirus vaccine in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

  • Alemtuzumab
  • Bendamustine
  • Betamethasone
  • Bortezomib
  • Bosutinib
  • Cabazitaxel
  • Capecitabine
  • Carboplatin
  • Carfilzomib
  • Carmustine
  • Chlorambucil
  • Cisplatin
  • Cladribine
  • Clofarabine
  • Corticotropin
  • Cortisone
  • Cosyntropin
  • Cyclophosphamide
  • Cytarabine
  • Cytarabine Liposome
  • Dacarbazine
  • Dasatinib
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Deflazacort
  • Dexamethasone
  • Docetaxel
  • Doxorubicin
  • Epirubicin
  • Etoposide
  • Fludarabine
  • Fludrocortisone
  • Fluocortolone
  • Fluorouracil
  • Gemcitabine
  • Gemtuzumab Ozogamicin
  • Hydrocortisone
  • Hydroxyurea
  • Idarubicin
  • Ifosfamide
  • Imatinib
  • Interferon Alfa
  • Irinotecan
  • Irinotecan Liposome
  • Lomustine
  • Mechlorethamine
  • Melphalan
  • Mercaptopurine
  • Methotrexate
  • Methylprednisolone
  • Mitomycin
  • Mitoxantrone
  • Nelarabine
  • Nilotinib
  • Ofatumumab
  • Oxaliplatin
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Paramethasone
  • Pemetrexed
  • Pentostatin
  • Ponatinib
  • Prednisolone
  • Prednisone
  • Procarbazine
  • Rituximab
  • Temozolomide
  • Teniposide
  • Thiotepa
  • Topotecan
  • Tositumomab
  • Triamcinolone
  • Vinblastine
  • Vinorelbine

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adalimumab
  • Antithymocyte Globulin Rabbit
  • Azathioprine
  • Brodalumab
  • Certolizumab Pegol
  • Dupilumab
  • Etanercept
  • Everolimus
  • Fingolimod
  • Golimumab
  • Guselkumab
  • Immune Globulin
  • Infliximab
  • Leflunomide
  • Mycophenolic Acid
  • Rilonacept
  • Sarilumab
  • Secukinumab
  • Sirolimus
  • Teriflunomide
  • Tocilizumab
  • Trabectedin
  • Ustekinumab

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blocked or slow bowels, history of or
  • Intussusception (serious bowel problem), history of or
  • Meckel's diverticulum (a bowel disease), history of or
  • Severe combined immunodeficiency disease (SCID) (an inherited disease), history of—Should not be used in patients with these conditions.
  • Blood disorders (e.g., leukemia, lymphoma) or
  • Cancer or
  • Receiving immunosuppressive treatment (e.g., corticosteroids) or
  • Weakened immune system (e.g., from HIV or AIDS)—These conditions may increase the risk for serious side effects. There is no evidence that this vaccine is safe or effective infants with these conditions.
  • Chronic diarrhea or
  • Digestive problems (e.g., abdominal or stomach surgery, active stomach illness) or
  • Failure to thrive (poor weight gain and physical growth failure) or
  • Vomiting—Use with caution. May make these conditions worse. There is no evidence that this vaccine is safe or effective in infants with these conditions.
  • Illness with fever, moderate or severe—Your child may need to wait until he or she feels better before receiving the vaccine.

Rotarix Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Diarrhea
  • earache
  • fever
  • headache
  • irritability
  • muscle aches
  • nausea and vomiting
  • pain or cramping in the abdomen or stomach
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Cough
  • difficulty with breathing
  • noisy breathing
  • shortness of breath
  • tightness in the chest
  • wheezing
Rare
  • Black, tarry stools
  • confusion
  • decreased urination
  • dizziness
  • dry mouth
  • fainting
  • increase in heart rate
  • lightheadedness
  • loss of appetite
  • rapid breathing
  • seizures
  • sunken eyes
  • thirst
  • unusual tiredness or weakness
  • wrinkled skin
Incidence not known
  • Blood in the urine
  • bloody nose
  • heavier menstrual periods
  • pinpoint red spots on the skin
  • red eyes
  • red mouth
  • skin rash
  • swollen glands
  • swollen hands and feet
  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Crying, fussiness, or irritability
  • runny nose
Less common
  • Bloated
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas
Incidence not known
  • Hives or welts
  • itching
  • redness of the skin
  • skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Drug Interactions

Concomitant Vaccine Administration

In clinical trials, Rotarix was administered concomitantly with US-licensed and non-US-licensed vaccines. In a US 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 Combined], a US-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.), and a US-licensed Hib conjugate vaccine (Sanofi Pasteur SA) were coadministered with Rotarix as compared with separate administration of Rotarix.

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 Warnings and Precautions (5.2).]

References

  1. Murphy TV, Gargiullo PM, Massoudi MS, et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564–572.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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

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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

Rx 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 2o to 8oC (36o to 46oF). 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 106.0 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 2o to 8oC (36o to 46oF) or at a room temperature up to 25oC (77oF), 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

What happens if I miss a dose?

Contact your doctor if you miss a booster dose or if you get behind schedule. Your child may not be protected from rotavirus if the doses aren't given within 10 weeks of each other. Be sure your child receives all recommended doses of Rotarix.

For the Consumer

Applies to rotavirus vaccine: oral powder for suspension, oral suspension

Along with its needed effects, rotavirus vaccine (the active ingredient contained in Rotarix) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking rotavirus vaccine:

More common
  • Diarrhea
  • earache
  • fever
  • headache
  • irritability
  • muscle aches
  • nausea and vomiting
  • pain or cramping in the abdomen or stomach
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
Less common
  • Cough
  • difficulty with breathing
  • noisy breathing
  • shortness of breath
  • tightness in the chest
  • wheezing
Rare
  • Black, tarry stools
  • confusion
  • decreased urination
  • dizziness
  • dry mouth
  • fainting
  • increase in heart rate
  • lightheadedness
  • loss of appetite
  • rapid breathing
  • seizures
  • sunken eyes
  • thirst
  • unusual tiredness or weakness
  • wrinkled skin
Incidence not known
  • Blood in the urine
  • bloody nose
  • heavier menstrual periods
  • pinpoint red spots on the skin
  • red eyes
  • red mouth
  • skin rash
  • swollen glands
  • swollen hands and feet
  • unusual bleeding or bruising

Some side effects of rotavirus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Crying, fussiness, or irritability
  • runny nose
Less common
  • Bloated
  • excess air or gas in the stomach or intestines
  • full feeling
  • passing gas
Incidence not known
  • Hives or welts
  • itching
  • redness of the skin
  • skin rash

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