Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Rotavirus vaccine

Generic name
Rotavirus vaccine
Brand name
ATC Code
J07BH01

Pharmacokinetics in children

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

ROTARIX: Active immunization against gastroenteritis caused by rotavirus
  • Oral
    • Premature infants Gestational age 27 weeks up to 37 weeks
      [1] [2]

      • From a postnatal age of 6 weeks: 2 doses at an interval of at least 4 weeks.
        Complete second dose before 16 weeks of age, but no later than 24 weeks of age

      • 1 dose = at least 1 million CCID50.

    • Term neonate
      [1]

      • From a postnatal age of 6 weeks: 2 doses at an interval of at least 4 weeks.
        Complete second dose before 16 weeks of age, but no later than 24 weeks of age

      • 1 dose = at least 1 million CCID50.
Dutch National Vaccination Programm: Rota virus vaccination
  • Oral
    • < 24 weeks
      [1]
        • 1st dose at postnatal age of 6-9 weeks, but no later than 12 weeks
        • 2nd dose at postnatal age of 3 months.

        1 dose = at least 1 million CCID50)

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Common (1-10%): diarrhoea. Irritability.

Uncommon (0.1-1%): abdominal pain, flatulence. Dermatitis.

Very rare (<0.01%): intussusception (see also Warnings and Precautions section). Urticaria.

Furthermore, apnea (in very premature children) have been reported. Bloody faeces. Gastroenteritis with vaccine virus shedding in children with SCID.

The rotavirus vaccines are associated with an increased risk of intussusception during the first 7 days after the first dose. It is not yet clear whether this is the case for the entire immunization. Symptoms that are an indication for intussusception (severe abdominal pain, persistent vomiting, bloody stools, a swollen stomach and/or high fever) should be monitored.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

  • acute severe fever;
  • diarrhea and vomiting;
  • history of intussusception, or an uncorrected congenital anomaly of the gastrointestinal tract that predisposes to intussusception;
  • severe combined immunodeficiency syndrome (SCID).

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Use with caution in infants with known or suspected immunodeficiency including in utero exposure to immunosuppressive therapy. No safety concerns have been observed in infants with asymptomatic HIV infection or with HIV infection with mild symptoms. Use with caution in infants with immunocompromised people in their close environment (such as individuals with malignancies or individuals undergoing immunosuppressive therapy) due to the risk of transmission of fecal excreted vaccine virus. After contact with recently vaccinated people, think about personal hygiene (eg washing hands).

Apnea: Be alert for the occurrence of apnea during primary immunization in very preterm infants (≤ 28 weeks gestation). Consider monitoring respiratory function for 48–72 hours, especially for children with a not yet fully developed respiratory system.

There is an increased risk of intussusception, usually within 7 days of vaccination administration; be alert for symptoms such as severe abdominal pain, persistent vomiting, bloody stools, abdominal distension and/or high fever.

There are no data on the safety and efficacy of rotavirus vaccine in infants with gastrointestinal disease or growth retardation.

There are no data on the use of rotavirus vaccine as post-exposure prophylaxis.

Live  vaccines (e.g., rotavirus vaccine) should not be given to infants exposed to infliximab in utero until 12 months after birth. Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless serum levels of infliximab are undetectable in the infant. These infants may be at increased risk of infection, including severe disseminated infection that can become fatal. [DHPC]

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Encephalitis vaccines
J07BA02
J07BA01
Influenza vaccines
J07BB02
Hepatitis vaccines
J07BC20
J07BC02
J07BC01
Measles vaccines
J07BD52
Poliomyelitis vaccines
J07BF03
Rabies vaccines
J07BG01
Varicella zoster vaccines
J07BK01
Yellow fever vaccines
J07BL01
Papillomavirus vaccines
J07BM03
J07BM02
Other viral vaccines
J07BX04

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References

  1. GlaxoSmithKline Biologicals s.a., SPC Rotarix EU/1/05/330/009-011, 21-02-11, www.ema.europa.eu
  2. LCI, Richtlijn rotavirus, www.rivm.nl, 01-10-2013
  3. Sanofi-Pasteur MSD, SNC, SmPC Rotateq (EU/1/06/348/001-002 27 juni 2011, www.ema.europa.eu
  4. Zorginstituut Nederland, Farmacotherapeutisch Kompas (Eigenschappen, Contra-Indicaties, Bijwerkingen, Waarschuwingen en Voorzorgen), Geraadpleegd 10-2-2022
  5. Representatives of marketing authorisation holders of infliximab, DHPC Infliximab 07 maart 2022,, https://www.cbg-meb.nl/documenten/brieven/2022/03/08/dhpc-infliximab

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Changes

Changes