Rotavirus Vaccine Live

Trade Names:
Rotarix
- Powder for suspension, lyophilized, oral rotavirus vaccine derived from human 89-12 strain (G1P[8] type), ≥ 10 ⁶ cell culture infective dose per 1 mL (after reconstitution)

Trade Names:
RotaTeq
- Oral suspension rotavirus outer capsid proteins from the human rotavirus parent strain and the attachment protein (2.2 × 10 ⁶ infectious units of G1, 2.8 × 10 ⁶ infectious units of G2, 2.2 × 10 ⁶ infectious units of G3, 2 × 10 ⁶ infectious units of G4 and 2.3 × 10 ⁶ infectious units of rotavirus attachment protein P1A) per 2 mL

Pharmacology

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Rotavirus vaccine is a live viral vaccine that replicates in the small intestine and induces immunity against rotavirus.

Indications and Usage

Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.

Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, and G4.

Contraindications

Hypersensitivity to any component of the product.

History of uncorrected congenital malformation of the GI tract (eg, Meckel diverticulum) that would predispose the infant for intussusception.

Infants developing hypersensitivity symptoms after receiving a dose should not receive further doses.

Dosage and Administration

PO 2 doses of 1 mL. Administer the first dose when infant is 6 wk of age. The interval between the first and last dose should be at least 4 wk. The series should be completed by 24 wk of age.

PO Three 2 mL doses administered at 4- to 10-wk intervals starting at 6 to 12 wk of age. Third dose should not be given after 32 wk of age.

General Advice

• For oral use. Not for injection.
• Administer without regard to food or liquid, including breast milk.
• May be coadministered with the following: diphtheria and tetanus toxoids and acellular pertussis (DTaP); inactivated poliovirus vaccine (IPV); Haemophilus influenza type b conjugate vaccine (Hib); hepatitis B vaccine; pneumococcal conjugate vaccine.
• Discard in biohazard waste container.
• Do not dilute or mix with any other oral vaccines or solutions.

• Rotarix
• Reconstitute only with accompanying diluent.
• When administered, infant should be seated in a reclining position.
• In the event that the infant spits out or regurgitates most of the dose, a single replacement dose may be considered at the same vaccination visit.

• RotaTeq
• Do not administer a replacement dose if an incomplete dose is administered for any reason (eg, infant spits out or regurgitates vaccine).

Storage/Stability

Store refrigerated at 36° to 46°F. After reconstitution, may be stored at up to 77°F. Discard reconstituted vaccine if not used within 24 h. Do not freeze. Discard if vaccine has been frozen.

Store and transport in refrigerator (36° to 46°F). Protect from light. Administer vaccine as soon as possible after removing from refrigerator.

Drug Interactions

Immune response to vaccines may be reduced.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Irritability (11%).

Dermatologic

Urticaria (postmarketing).

EENT

Otitis media (15%); nasopharyngitis (7%).

GI

Vomiting (13%); diarrhea (4%); flatulence (2%); bloody stool, intussusception (postmarketing).

Diarrhea (24%); vomiting (15%); bloody stool, intussusception including death (postmarketing).

Hematologic-Lymphatic

Idiopathic thrombocytopenic purpura (postmarketing).

Respiratory

Bronchospasm (1%).

Miscellaneous

Death (0.2%).

Elevated temperature (20%); Kawasaki disease (postmarketing).

Precautions

Pregnancy

Category C .

Children

Safety and efficacy not established in infants younger than 6 wk of age or older than 24 wk of age.

Safety and efficacy not established in infants younger than 6 wk of age or older than 32 wk of age.

Hypersensitivity

Review immunization history for hypersensitivity and other reactions to any component of the product, including latex rubber (contained in the oral applicator).

Hypersensitivity may occur after any dose of vaccine; do not administer subsequently.

Febrile illness

Delay administration of rotavirus vaccine during febrile illness (fever higher than 100.5°F) unless health care provider determines that withholding the vaccine entails a greater risk.

GI disorders

Delay administration in infants suffering from acute diarrhea or vomiting. Safety and efficacy not evaluated in infants with chronic GI disorders.

No safety or efficacy data available. Use with caution in infants with history of GI disorders (eg, abdominal surgery, active acute GI illness, chronic diarrhea, congenital abdominal disorders, failure to thrive, intussusception).

Immunocompetence

Safety and efficacy in infants with known primary or secondary immunodeficiencies, including HIV infections or malignant neoplasm affecting the bone marrow or lymphatic system, have not been evaluated.

No safety and efficacy data available for administration of rotavirus vaccine to infants who are potentially immunocompromised.

Immunodeficient close contacts of vaccine recipient

Use caution when considering administration of vaccine to persons with immunodeficient close contacts.

Intussusception

No evidence of increased risk of intussusception with current rotavirus vaccine.

Latex

Oral applicator contains latex rubber that may cause allergic reactions in latex-sensitive persons.

Level of protection

Level of protection provided by only 1 or 2 doses of rotavirus vaccine has not been established.

Postexposure prophylaxis

There are no clinical data regarding administration of rotavirus vaccine after exposure to rotavirus.

Shedding and transmission

Rotavirus shedding in stool occurs after vaccination, with peak excretion occurring around 7 days after the dose. Transmission of virus was not evaluated.

Theoretical risk that live virus vaccine can be transmitted to nonvaccinated contacts. Weigh theoretical risk of vaccine virus transmission against risk of acquiring and transmitting natural rotavirus.

Overdosage

Symptoms

None documented.

Patient Information

• Determine current health status and previous vaccination history, including whether there has been a reaction to a previous dose of this or other rotavirus vaccines.
• Provide and review the Vaccine Information Statements prior to immunization.
• Advise parent or caregiver to review the patient information leaflet before vaccine is administered.
• Review immunization schedule.
• Provide parent or guardian with an immunization history record and log this immunization in the patient's immunization record.

• Rotarix
• Instruct parent or guardian to contact health care provider immediately or to go to an emergency room if the infant experiences bloody bowel movements, high fever, severe diarrhea or vomiting, or severe stomach pain.

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