Rotarix

rotavirus vaccine, live, oral

(ro-ta-vye-russ vak-seen) ,

Rotarix

(trade name),

Rotateq

(trade name)

Classification

Therapeutic: vaccines immunizing agents
Pharmacologic: active immunizer
Pregnancy Category: C

Indications

Prevention of rotavirus gastroenteritis in infants.

Action

Live attenuated vaccine replicates in the small intestine and produces immunity.

Therapeutic effects

Prevention of rotavirus gastroenteritis and its sequelae.

Pharmacokinetics

Absorption: Unknown.
Distribution: Remains in GI tract.
Metabolism and Excretion: Excreted in feces.
Half-life: Unknown.

Time/action profile

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

Contraindicated in: Hypersensitivity; History of intussusception; Severe combined immunodeficiency disease.
Use Cautiously in: Acute diarrhea or vomiting (delay immunization); Chronic gastrointestinal disorders (safety and efficacy not established); Febrile illness; Immunosuppression due to disease (including HIV), concurrent immunosuppressive drug therapy, malignant neoplasms affecting bone marrow/lymphatic system, or receipt of blood transfusion or blood products (including immunoglobulins) (safety and effectiveness not established).

Adverse Reactions/Side Effects

Respiratory

  • cough

Ear, Eye, Nose, Throat

  • runny nose

Gastrointestinal

  • Intussusception (life-threatening)
  • flatulence
  • loss of appetite
  • rotavirus shedding in stool
  • vomiting

Miscellaneous

  • fussiness/irritability

Interactions

Drug-Drug interaction

Concurrent immunosuppressants, antineoplastics, corticosteroids or radiation therapy may ↓ antibody response and ↑ risk of adverse reactions.

Route/Dosage

Rotarix

Oral (Infants 6–24 wk) 2 dose series; first dose at 6 weeks of age, followed at least 4 weeks later with a second dose; series should be completed by 24 weeks of age.

Rotateq

Oral (Infants 6–32wk) 3 dose series; first dose at 6–12 weeks of age, followed by the 2nd and 3rd doses at 4–10 week intervals; series should be completed by 32 weeks of age.

Availability

Powder for oral suspension (Rotarix) (requires reconstitution): 1 mL prefilled oral applicator (applicator contains latex)
Oral solution (Rotateq): 2 mL prefilled dosing tube

Nursing implications

Nursing assessment

  • Determine current health status and previous vaccination history of infant, including any reactions to previous dose of rotavirus vaccine. Delay administration in infants with acute diarrhea and vomiting.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • May be administered with food or liquid, including breast milk, either before or after vaccination.
  • Oral: For Rotarix: Remove vial cap and push transfer adaptor into vial. Shake diluent in oral applicator (white, turbid suspension); push plunger of oral applicator to transfer diluent into vial. Reconstitute only with accompanying diluent. Do not mix with other vaccines or solutions. Do not administer if vial has cracks. Withdraw vaccine in oral applicator and twist to remove oral applicator. Do not use a needle; not for injection Vials of vaccine may be stored in the refrigerator and diluent may be stored at room temperature. Do not freeze. Administer within 24 hr of reconstitution. Discard in biological waste container if not used within 24 hrs.
    • If infant spits out or regurgitates most of dose, single replacement dose may be considered at same vaccination visit.
  • For RotaTeq: Open the dosing tube and puncture dispensing tip by screwing cap clockwise until it becomes tight. Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. A residual drop may remain in the tip of the tube.
    • If infant spits out or regurgitates most of dose, a replacement dose is not recommended. The infant should continue to receive any remaining doses in the recommended series.

Patient/Family Teaching

  • Instruct parents or guardians to read Patient Information before first dose and prior to second dose and ask any questions they may have during the visit. Provide parent or guardian with the Vaccine Information Statements available at www.cdc.gov/nip. Emphasize the importance of completing the immunization series.
  • Advise parent to contact health care professional immediately if signs of intussusception (vomiting, diarrhea, severe stomach pain, severe crying, blood in the stool, or change in bowel movements) occur even if it has been several months since last vaccine dose.

Evaluation/Desired Outcomes

  • Prevention of rotavirus gastroenteritis and its sequelae.

Rotarix

(rōt′ă-riks″),

RV1

Human live, oral rotavirus vaccine, monovalent.
References in periodicals archive ?
Vaccines offered are Polio, hepatitis B, Menveo (Meningitis vaccine), DTaP, TD, Tdap, Varicella (chickenpox), MMR, Prevnar (pneumonia), Pediarix (DTaP-HEPB-IPV Combo), Rotarix, hepatitis A, and Gardasil (Human Papillomavirus vaccine).
These vaccines include Prevnar/ Prevnar 13, Gardasil/ Gardasil 9, Vaxigrip, Fluzone, Flublok, Varivax, Proquad, Menactra, Fluarix/ FluLaval, Pneumovax 23, Havrix/ Twinrix/ Engerix-B, Priorix, Priorix Tetra, Varilrix, M-M-R II, Adacel, Boostrix, Menveo, Bexsero, Cervarix, Shingrix, Trumenba, Rotateq, Pentacel, Pentaxim, Imovax, Hexaxim, Zostavax, Rotarix, Sunflorix, Pediarix, Infanrix, Ticovac, Biken Ha, Tetrabik, Mearubik, Varicella (MTP), Jebik V, Flumist/ Fluenz, Bio Thrax, Dukoral, In Live, Ixiaro, HeaLive, In Live, BiLive, EasySix, Imvamune, and Anflu.
Despite wide temporal and regional diversity of rotavirus strains being reported throughout the Indian subcontinent, a study based in Lahore, Pakistan identified the G2P and G9 genotypes as the most prevalent among children suffering acute gastroenteritis.2 Nevertheless, it has been shown that rotavirus vaccines (Rotarix and Rotateq) generate heterotypic immune response, providing equivalent efficacy against a vast range of rotavirus genotypes.
Rotarix is a monovalent vaccine of rotavirus strain G1P8 attenuated in Vero cell culture.
([paragraph][paragraph]) Includes [greater than or equal to] 2 doses of Rotarix monovalent rotavirus vaccine (RV1), or [greater than or equal to] 3 doses of RotaTeq pentavalent rotavirus vaccine (RV5).
According to the FDA's industry guidelines on vaccine production, the removal of foreign DNA and protein contamination from vaccines employing human and animal cell lines is a "non-binding recommendation." (15) A recent example of a vaccine temporarily removed from the market by the FDA is Glaxo's rotavirus vaccine Rotarix. In 2010, an independent California laboratory identified a foreign pig virus, porcine circovirus 1 or PCV1, present in Rotarix.
The results of the study conducted in 7,500 infants across 6 Indian sites demonstrated that Rotasiil's efficacy was comparable to the performance of the leading RotaTeq and Rotarix brands in Bangladesh and in some African countries, according to the study published in the journal Vaccine.
The results demonstrated by ROTASIIL in India appear generally comparable to the performance of RotaTeq and Rotarix in Bangladesh and in some African countries.
The efficacy is around 58% for Rotarix and 83% for Rotateq, by different ways of assessment [21, 22].
She had received her 4-month vaccines (Rotarix, Pediarix, Hib, and Prevnar) at a health supervision visit 7 days prior to presentation to the local emergency department
Mixing the RotaTeq and Rotarix rotavirus vaccines schedules resulted in noninferior immunogenicity compared with using only one vaccine schedule, found a new multicenter, open-label study, said Dr.
In June 2013, the CDC published a study in the journal Pediatrics that analyzed the VAERS database to assess intussusception events in recipients of two rotavirus vaccines, RotaTeq and Rotarix. (Intussusception is a serious intestinal condition that may require emergency surgery and can be fatal.) Although there were hundreds of confirmed intussusception events after vaccination, and a statistically significant clustering of intussusception events 3 to 6 days after the first dose of RotaTeq vaccination, CDC researchers concluded that an increased risk of intussusception "is outweighed by the benefits of rotavirus vaccination." (6)