Vaccine, rotavirus

Oral
Prevention of rotavirus gastroenteritis

May be taken with or without food.

Hypersensitivity. History of intussusception, uncorrected congenital malformations of the gastrointestinal tract (e.g. Meckel’s diverticulum) that would predispose to intussusception, severe combined immunodeficiency (SCID) disorder. Children born to mothers who received immunosuppressive biological therapy during pregnancy.

Patient with or with history of gastrointestinal illnesses, chronic diarrhoea, congenital abdominal disorders, failure to thrive, abdominal surgery, immunodeficiency, growth retardation, minor illnesses, personal or family history of febrile convulsions. Postpone vaccination in patients with diarrhoea, vomiting or acute severe febrile illness. Children. Pregnancy.

Ear and labyrinth disorders: Otitis media.
Gastrointestinal disorders: Diarrhoea, flatulence, vomiting, haematochezia.
General disorders and administration site conditions: Irritability, fever.
Metabolism and nutrition disorders: Loss of appetite.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, cough, runny nose.
Vascular disorders: Kawasaki disease.
Potentially Fatal: Anaphylactoid or hypersensitivity reactions, intussusception.

PO: C

Reduced immune response or risk of generalised infection when used concomitantly with immunosuppressants (e.g. corticosteroids).

May interfere with tuberculin tests.

Description:
Mechanism of Action: Rotavirus is one of the important causes of severe acute gastroenteritis in infants and young children. There are 2 commercially available forms of rotavirus vaccine, including, a) live, attenuated monovalent vaccine derived from human strain indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4 and G9 serotypes; and b) live, pentavalent human-bovine reassortant vaccine indicated for prevention of gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and G9. Although presence of porcine circoviruses (PCV1 and PCV2) DNA have been detected in the rotavirus vaccine, current available information shows that there is no evidence that PCV1 or PCV2 poses a safety risk to humans. The exact immunologic mechanism by which the vaccine protects against rotavirus gastroenteritis is unknown. However, studies suggest a combination of factors is important in rotavirus immunity including neutralising antibodies to the outer capsid G proteins, serum and secretory IgA, and other local mucosal responses.

Store between 2-8°C. Do not freeze. Protect from light.
Any unused portions should be disposed of in accordance with local requirements.

Vaccines, Antisera & Immunologicals

J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.

Anon. Rotavirus Vaccine Live Oral. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 26/06/2018.

Anon. Rotavirus Vaccine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/06/2018.

Buckingham R (ed). Rotavirus Vaccine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2018.

Joint Formulary Committee. Rotavirus Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/06/2018.

Rotarix (GlaxoSmithKline Biologicals SA). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2018.

RotaTeq (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 26/06/2018.