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Rotavirus Vaccine

Pronunciation

(ROE ta vye rus vak SEEN)

Index Terms

  • Human Rotavirus Vaccine, Attenuated (HRV)
  • Pentavalent Human-Bovine Reassortant Rotavirus Vaccine (PRV)
  • Rotavirus Vaccine, Pentavalent
  • RV1 (Rotarix)
  • RV5 (RotaTeq)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Powder, for suspension, oral [preservative free; human derived]:

Rotarix: G1P[8] ≥106 CCID50 per 1 mL [contains sorbitol, sucrose; supplied with diluent which may contain natural rubber/natural latex in packaging]

Solution, oral [preservative free; bovine and human derived]:

RotaTeq: G1 ≥2.2 x 106 infectious units, G2 ≥2.8 x 106 infectious units, G3 ≥2.2 x 106 infectious units, G4 ≥2 x 106 infectious units, and P1A [8] ≥2.3 x 106 infectious units per 2 mL (2 mL) [contains sucrose]

Brand Names: U.S.

  • Rotarix
  • RotaTeq

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

A live vaccine; replicates in the small intestine and promotes active immunity to rotavirus gastroenteritis. Rotarix is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G3, G4, and G9 and RotaTeq is specifically indicated for prevention of rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4. However, these vaccines may provide immunity to other rotavirus serotypes.

Onset of Action

Seroconversion:

Rotarix: Antirotavirus IgA antibodies were noted 1 to 2 months following completion of the 2-dose series in 77% to 87% of infants.

RotaTeq: A threefold increase in antirotavirus IgA was noted following completion of the 3-dose regimen in 93% to 100% of infants.

Duration of Action

Following administration of rotavirus vaccine, efficacy of protecting against any grade of rotavirus gastroenteritis through two seasons was 71% to 79%.

Use: Labeled Indications

Rotavirus gastroenteritis prevention:

Rotarix: Prevention of rotavirus gastroenteritis in infants 6 to 24 weeks of age caused by the serotypes G1,G3, G4, and G9 when administered as a 2-dose series.

RotaTeq: Prevention of rotavirus gastroenteritis in infants 6 to 32 weeks of age caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all infants (CDC/ACIP [Cortese, 2009]).

Contraindications

Hypersensitivity to rotavirus vaccine or any component of the formulation; history of uncorrected congenital malformation of the GI tract (such as Meckel diverticulum) that would predispose the infant for intussusception (Rotarix only); history of intussusception; severe combined immunodeficiency disease

Dosing: Pediatric

Prevention of rotavirus gastroenteritis: Oral:

Manufacturer's labeling:

Infants 6 to 24 weeks of age: Rotarix: A total of two 1 mL doses (U.S. labeling) or two 1.5 mL doses (Canadian labeling), the first dose given at 6 weeks of age, followed by the second dose given ≥4 weeks later. The 2-dose series should be completed by 24 weeks of age.

Infants 6 to 32 weeks of age: RotaTeq: A total of three 2 mL doses, the first dose given at 6 to 12 weeks of age, followed by subsequent doses at 4- to 10-week intervals. Administer all doses by 32 weeks of age.

ACIP recommendations (CDC/ACIP [Cortese, 2009]): The first dose can be given at 6 to 14 weeks of age. The series should not be started in infants ≥15 weeks. The final dose in the series should be administered by 8 months 0 days of age. The minimum interval between doses is 4 weeks. RotaTeq should be given in 3 doses administered at 2-, 4-, and 6 months of age. Rotarix should be given in 2 doses administered at 2- and 4 months of age. For infants inadvertently administered rotavirus vaccine at ≥15 weeks of age, the vaccine series may be completed according to schedule. The ACIP recommends to complete the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown, vaccination should be completed with the product available. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given. Infants who have had rotavirus gastroenteritis before getting the full course of vaccine should still initiate or complete the recommended schedule; initial infection provides only partial immunity.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Rotarix: Reconstitute only with provided diluent and transfer adapter. After removing the vial cap, connect transfer adapter onto vial and push downwards until transfer adapter is in place. Shake oral applicator containing the liquid diluent (suspension will be a turbid liquid). Connect oral applicator to transfer adapter and transfer entire contents (diluent) of oral applicator into the lyophilized vaccine. With transfer adapter in place, shake vigorously. Withdraw entire mixture back into oral applicator. Twist and remove oral applicator.

RotaTeq: Clear the fluid from the dispensing tip by holding the tube vertically and tapping the cap. Puncture the dispensing tip by screwing the cap clockwise until it becomes tight and then remove the cap by turning it counterclockwise.

Administration

For oral administration only; do not give by injection. May be administered before or after food, milk, or breast milk. To avoid potential eye splashes caused by coughing, sneezing, and spitting, administer gently inside the cheek (CDC [Hibbs, 2014]). US federal law requires that the name of medication, date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

Rotarix: Using oral applicator, administer contents into infant’s inner cheek. Dispose of applicator and vaccine vial in biologic waste container.

RotaTeq: Gently squeeze dose from ready-to-use dosing tube into infant’s inner cheek. After use, dispose of the empty tube and cap in a biologic waste container.

Note: Although the Rotarix prescribing information states that a regurgitated or spit out dose may be repeated, the AAP, ACIP, and the RotaTeq prescribing information do not recommend readministering doses. Any remaining dose(s) should be administered on schedule (AAP, 2009; CDC/ACIP [Cortese, 2009]).

Dietary Considerations

May be administered before or after food, milk, or breast milk.

Storage

Rotarix: Store intact vials under refrigeration at 2°C to 8°C (36°F to 46°F); diluent may be stored under refrigeration at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25°C (77°F). Protect vaccine from light; discard diluent if frozen. Following reconstitution, may be refrigerated at 2°C to 8°C (36°F to 46°F) or stored at room temperature up to 25°C (77°F) for up to 24 hours. Discard if frozen. Note: In Canada, Rotarix is available as an oral suspension ready for use and does not need to be reconstituted. The oral suspension may be stored at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light.

RotaTeq: Store and transport under refrigeration at 2°C to 8°C (36°F to 46°F). Use as soon as possible once removed from refrigerator. Protect from light. Canadian labeling suggests that once the vaccine is removed from refrigeration, it may be stored at temperatures up to 25°C (77°F) for up to 4 hours; do not freeze. Protect from light.

Drug Interactions

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; Dexamethasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of methotrexate should be avoided. Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. Consider therapy modification

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

Test Interactions

Tuberculin tests: Rotavirus vaccine may diminish the diagnostic effect of tuberculin tests.

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index.

Note: Ranges reported; actual percentage may vary between products.

>10%:

Central nervous system: Fever ≥38.1°C (17% to 43%; equal to or less than placebo), fussiness/irritability (3% to 52%)

Gastrointestinal: Diarrhea (4% to 24%), vomiting (3% to 15%)

Otic: Otitis media (15%)

1% to 10%:

Gastrointestinal: Flatulence (2%)

Respiratory: Nasopharyngitis (7%), bronchospasm (1%)

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, gastroenteritis with severe diarrhea and prolonged vaccine viral shedding in infants with SCID, hematochezia, immune thrombocytopenia (ITP), intussusception, Kawasaki disease, seizure, transmission of vaccine virus from recipient to nonvaccinated contacts, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine administration (NCIRD/ACIP, 2011).

• Intussusception: An increased risk of intussusception was observed with a previously licensed rotavirus vaccine. Cases have been noted in postmarketing reports and a temporal association has been observed in postmarketing observational studies with current vaccines. Cases were noted within 21 to 31 days of the first dose, with a clustering of cases within the first 7 days following administration. An increased risk was also observed within the first 7 days of the second dose. Use of RotaTeq and Rotarix is contraindicated with a history of intussusception. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose.

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP, 2011).

• Gastrointestinal disease: Use with caution in infants with history of GI disorders, acute mild GI illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, and abdominal surgery; vaccine may be used with controlled gastroesophageal reflux disease. ACIP recommends that the vaccine should generally not be administered to infants with acute moderate or severe gastroenteritis. (CDC/ACIP [Cortese, 2009]). Rotarix is contraindicated with a history of an uncorrected congenital malformation of the GI tract; RotaTeq and Rotarix are contraindicated with a history of intussusception.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (NCIRD/ACIP, 2011).

Special populations:

• Adults: Not intended for use in adults.

• Immunocompromised family members: Virus from live virus vaccines may be transmitted to nonvaccinated contacts; use with caution in the presence of immunocompromised family members. Viral shedding occurs within the first weeks of administration; peak viral shedding generally occurs ~7 days after the first dose. The ACIP recommends vaccination of infants living in households with persons who are immunocompromised (CDC/ACIP [Cortese, 2009]).

• Immunocompromised infants: Safety and efficacy have not been established for use in immunocompromised infants (including blood dyscrasias, leukemia, lymphoma, malignant neoplasms affecting bone marrow or lymphatic system), infants on immunosuppressants (including high-dose corticosteroids; may be administered with topical corticosteroids or inhaled steroids), or infants with primary and acquired immunodeficiencies (including HIV/AIDS, cellular immune deficiencies, hypogammaglobulinemic and dysgammaglobulinemic states). The ACIP recommendations support vaccination of HIV-exposed or infected infants, since the diagnosis of infection may not be made prior to the first dose of the vaccine and also because strains of rotavirus vaccine are considerably attenuated (CDC/ACIP [Cortese, 2009]). In general, live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible. Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin, 2014).

Dosage form specific issues:

• Latex: Some packaging may contain natural latex/natural rubber

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).

• Appropriate use: Administration errors have been reported. This vaccine is for oral administration only; doses inadvertently administered by injection are not considered valid and an oral replacement dose should be given according to the appropriate age and schedule (CDC [Hibbs, 2014]).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP, 2011).

• Postexposure prophylaxis: Information is not available for use in postexposure prophylaxis.

Pregnancy Risk Factor

C

Pregnancy Considerations

Reproduction studies have not been conducted. Not indicated for use in women of reproductive age. Infants living in households with pregnant women may be vaccinated (CDC/ACIP [Cortese, 2009]).

Patient Education

• Discuss specific use of vaccine and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience irritability, rhinorrhea, lack of appetite, abnormal crying, or pharyngitis. Have caregiver report immediately to prescriber ear pain, wheezing, cough, blood in stool, severe diarrhea, vomiting, abdominal pain, or signs of Kawasaki disease (high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs) (HCAHPS).

• Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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