Rotavirus Oral Vaccine Live

Rotavirus Oral Vaccine, Live is a live attenuated oral vaccine indicated for immunization to prevent rotavirus gastroenteritis in infants and children.

• Rotavirus Oral Vaccine, Live is available under the following different brand names: Rotarix, RotaTeq

Common side effects of the Rotavirus Oral Vaccine, Live include:

• mild fussiness
• crying
• mild diarrhea
• vomiting
• stuffy nose
• sinus pain
• sore throat

Serious side effects of the Rotavirus Oral Vaccine, Live include:

• seizure
• severe or ongoing diarrhea
• ear pain, swelling, or drainage
• fever
• chills
• cough with yellow or green mucus
• stabbing chest pain
• wheezing
• shortness of breath
• pain or burning with urination
• high fever
• redness of the skin or eyes
• swollen hands
• peeling skin rash
• chapped or cracked lips

Rare side effects of the Rotavirus Oral Vaccine, Live include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

Oral vaccine

• Rotarix
  • Monovalent
  • 89-12 strain (G1P[8] type); 10^6 cell culture infective dose or more
• RotaTeq
  • Pentavalent

Rotavirus Gastroenteritis Prophylaxis

Pediatric dosage

• RotaTeq: 3 Dose Regimen
  • Total of three 2 mL doses were administered orally
  • First dose is given at 6-12 weeks of age
  • Subsequent doses administered at 4-10 week intervals
  • The third dose should not be given after 32 weeks of age
• Rotarix: 2-Dose Regimen
  • Total of two 1 mL doses were administered orally
  • Administer the first dose to infants beginning at 6 weeks of age
  • Administer the second dose after at least 4 weeks and before 24 weeks of age

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Rotavirus Oral Vaccine, Live has severe interactions with the following drugs.
  • belimumab
  • certolizumab pegol
  • ibrutinib
  • ifosfamide
  • ixekizumab
  • lomustine
  • mechlorethamine
  • melphalan
  • methotrexate
  • onasemnogene abeparvovec
  • oxaliplatin
  • procarbazine
  • secukinumab
  • ustekinumab
• Rotavirus Oral Vaccine, Live has serious interactions with at least 65 drugs
• Rotavirus Oral Vaccine, Live has moderate interactions with the following drugs:
  • anthrax immune globulin
  • belatacept
  • betibeglogene autotemcel
  • leniolisib
  • obinutuzumab
  • ublituximab
• Rotavirus Oral Vaccine, Live has minor interactions with the following drug:
  • chloroquine

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Immunosuppression
• Infants with severe combined immunodeficiency disease (SCID)
• Infants aged less than 6 weeks and greater than 32 weeks
• History of uncorrected congenital malformation of the GI tract that would predispose the infant to intussusception.
• Infants with a history of intussusception 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Rotavirus Oral Vaccine, Live?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Rotavirus Oral Vaccine, Live?”

Cautions

• Do not reconstitute or dilute
• Postpone administration in moderate or severe acute illness (with or without fever)
• Caution with a history of GI disorders
• Not for use in adults
• Use caution when administered in the presence of immunocompromised family members (viral shedding occurs within the first weeks of administration)
• Safety and efficacy not established for use in immunocompromised infants
• Postmarketing reports of Kawasaki disease in some recipient infants
• Effectiveness unknown for postexposure prophylaxis
• Vaccination may not result in effective immunity in all patients
• Intussusception
  • Postmarketing reports of intussusception and hematochezia; interim postmarketing safety data from the study suggest an increased risk of intussusception in the 31 days following the first dose (most often within the first 7 days)
  • Intussusception incidence in the U.S. is estimated to be 1 to 5 cases per 100,000 vaccinees In a study of 1.5 million infants, the monovalent vaccine showed a relative risk of 8.4 and the pentavalent vaccine did not show increased risk compared with historical background rates of intussusception; N Engl J Med Jan 2014
  • Another study observed an increased risk with the pentavalent vaccine, but was underpowered to evaluate the monovalent form and involved ~600,000 infant years; N Engl J Med Jan 2014

Pregnancy and Lactation

• Not for use in adults
• Lactation
  • Not for use in adults