Pronunciation:

ROE-ta-vye-rus VAX-een lyve, pen-ta-VAY-lent

Brand Names:

• RotaTeq

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

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

Rotavirus is a serious infection that causes diarrhea and vomiting. This infection may also lead to severe dehydration in infants and children.

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

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 rotavirus vaccine live pentavalent in infants younger than 6 weeks of age or older than 32 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 rotavirus vaccine live pentavalent 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.

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.

• Aclarubicin
• Aldesleukin
• Altretamine
• Amonafide
• Amsacrine
• Asparaginase
• Azacitidine
• Betamethasone
• Bleomycin
• Broxuridine
• Busulfan
• Capecitabine
• Carboplatin
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Corticotropin
• Cortisone
• Cosyntropin
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dactinomycin
• Daunorubicin
• Daunorubicin Citrate Liposome
• Decitabine
• Deflazacort
• Dexamethasone
• Docetaxel
• Doxifluridine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Edatrexate
• Eflornithine
• Epirubicin
• Estramustine
• Etoposide
• Floxuridine
• Fludarabine
• Fludrocortisone
• Fluocortolone
• Fluorouracil
• Fotemustine
• Gallium Nitrate
• Gemcitabine
• Hydrocortisone
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Interferon Alfa
• Interferon Alfacon-1
• Interferon Beta
• Interferon Beta-1a
• Interferon Beta-1b
• Interferon Gamma
• Irinotecan
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Methylprednisolone
• Mitolactol
• Mitomycin
• Mitotane
• Mitoxantrone
• Oxaliplatin
• Paclitaxel
• Paclitaxel Protein-Bound
• Paramethasone
• Pegaspargase
• Pentostatin
• Pipobroman
• Pirarubicin
• Plicamycin
• Prednisolone
• Prednisone
• Procarbazine
• Raltitrexed
• Rituximab
• Streptozocin
• Teceleukin
• Tegafur
• Teniposide
• Thioguanine
• Thiotepa
• Topotecan
• Treosulfan
• Triamcinolone
• Trimetrexate
• Trofosfamide
• Uracil Mustard
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome
• Vindesine
• 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
• Alemtuzumab
• Azathioprine
• Certolizumab Pegol
• Etanercept
• Everolimus
• Fingolimod
• Golimumab
• Immune Globulin
• Infliximab
• Mycophenolic Acid
• Rilonacept
• Secukinumab
• Siltuximab
• Sirolimus
• Tacrolimus
• Temsirolimus
• 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
• Leflunomide
• Vaccinia Immune Globulin, Human

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:

• Blood disorders (e.g., leukemia, lymphoma) or
• Receiving immunosuppressive treatment (e.g., corticosteroids) or
• Weakened immune system (e.g., HIV or AIDS)—There is no evidence that this vaccine is safe or effective in 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)—Use with caution. 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.

• Severe combined immunodeficiency disease or SCID (an inherited disease), history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. It is given by mouth.

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 child's 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.

• For oral dosage form (solution):
  • To prevent rotavirus infection:
    • Infants and children 32 weeks (8 months) of age and older—Use and dose must be determined by your doctor.
    • Infants 6 weeks of age to 32 weeks of age—The first dose should be given when your child is 6 to 12 weeks of age. The second dose should be given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks (8 months) of age.
    • Infants younger than 6 weeks of age—Use and dose must be determined by your doctor.

Precautions While Using This Medicine:

It is very important that your child return to your doctor's office at the right time for his or her next dose of this vaccine. Be sure to notify your child's doctor of any side effects that occur after your child receive this vaccine.

Make sure your child's doctor knows if your child has any type of cancer or is receiving a treatment that may weaken the immune system (steroid medicine, radiation treatment, or medicine to treat cancer). Tell you child's doctor if your child has received a blood transfusion or blood products within the past 42 days.

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

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 maybe 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 immediately if any of the following side effects occur:

More common

Diarrhea

earache

fever

headache

irritability

muscle aches

sore throat

stuffy or runny nose

unusual tiredness or weakness

vomiting

Less common

Cough

difficulty with breathing

noisy breathing

shortness of breath

tightness in the chest

wheezing

Rare

Black, tarry stools

seizures

Incidence not known

Nausea

pain or cramping in the abdomen or stomach

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

Irritability

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.