Pronunciation:

ROE-ta-vye-rus VAX-een, lyve

Brand Names:

• Rotarix
• RotaTeq

Dosage Forms:

• Powder for Suspension
• Suspension

Classifications:

Therapeutic—

Vaccine, Live

Uses of This Medicine:

Rotavirus vaccine live is used to prevent infants and children from getting a rotavirus stomach infection. It works by causing your body to produce its own protection (antibodies) against the virus.

Rotavirus is a serious infection that causes diarrhea and vomiting. It may also cause severe dehydration in infants and children.

This vaccine is to be administered only by or under the supervision of your child's doctor.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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
• Bortezomib
• Bosutinib
• Budesonide
• Cabazitaxel
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cortisone
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deflazacort
• Dexamethasone
• Docetaxel
• Doxorubicin
• Epirubicin
• Etoposide
• Fludarabine
• Fludrocortisone
• 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
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Brexucabtagene Autoleucel
• Brodalumab
• Canakinumab
• Certolizumab Pegol
• Cyclosporine
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Etanercept
• Etrasimod
• Everolimus
• Fingolimod
• Golimumab
• Guselkumab
• Hyaluronidase
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Ixekizumab
• Leflunomide
• Leniolisib
• Lovotibeglogene Autotemcel
• Mirikizumab-mrkz
• Mycophenolic Acid
• Ocrelizumab
• Ozanimod
• Ponesimod
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rozanolixizumab-noli
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Trabectedin
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Voclosporin

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
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Other interactions—

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 (eg, leukemia, lymphoma) or
• Cancer or
• Receiving immunosuppressive treatment (eg, corticosteroids) or
• Weakened immune system (eg, 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 (eg, 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.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. It is given by mouth. The dose is specific to the brand of the rotavirus vaccine and the age of the child.

This medicine needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child’s doctor for another appointment.

This medicine comes with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions While Using This Medicine:

It is very important that your child's doctor check your child's progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.

Make sure your child's doctor knows if your child has any type of cancer or is receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation.

Tell your child's doctor if your child spends time with a person who has an immune system problem or is getting cancer medicines. Your doctor may recommend ways (eg, proper hand washing after changing of diapers) to help prevent the spread of vaccine virus to other people.

The oral applicator of this vaccine may contain dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These could be symptoms of a serious bowel problem called intussusception.

Side Effects of This Medicine:

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

Chest tightness

cough

noisy breathing

trouble breathing

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.