Drugs List

Therapeutic Indications

Uses

Active immunisation of infants against rotavirus infection

Active immunisation of infants aged 6 to 24 weeks for prevention of gastro-enteritis due to rotavirus infection.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Contraindications

Children under 6 weeks
Diarrhoea
Infants under 6 months exposed to immunosuppressive biological in utero
Patients over 24 weeks
Severe febrile conditions
Vomiting
Congenital malformation of the gastrointestinal tract
Hereditary fructose intolerance
History of intussusception
Severe Combined Immunodeficiency (SCID)

Precautions and Warnings

Immunosuppression
Infants exposed to immunosuppressive biological therapy via breast milk
Glucose-galactose malabsorption syndrome
Immunodeficiency syndromes

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Vaccine may not be effective in 100% of patients
Preparation contains sucrose
Strict hygiene near the immunocompromised:Longer viral presence in faeces
Establish full medical history and health status prior to vaccine
Risk of apnoea in premature infants - monitor respiration for 72 hours
Advise carer to report symptoms of intussusception
Follow national immunisation guidelines
Advise contacts of recent vaccinees of need for strict personal hygiene

There are no data on the safety and efficacy of the vaccine in infants with gastrointestinal illnesses or growth retardation. Administration of the vaccine may be considered with caution in such infants when withholding the vaccine entails a greater risk.

Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of the vaccine. Careful consideration of potential benefits and risks should be given when administering the rotavirus vaccine to infants who have known or suspected immunodeficiency.

Excretion of the vaccine virus in the stools is known to occur, with the peak excretion around the seventh day. Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccines have been observed without causing any clinical symptoms.

The potential risk of apnoea and the need for respiratory monitoring for 48h to 72h should be considered when administering the primary immunisation series to very premature infants (born after 27 weeks gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.

The vaccine does not protect against gastro-enteritis due to other pathogens than rotavirus.

No data are available on the use for post-exposure prophylaxis.

Pregnancy and Lactation

Pregnancy

The vaccine is not intended for use in adults.

Human data on use during pregnancy are not available and animal reproduction studies have not been performed.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The vaccine is not intended for use in adults.

Human data on use during breastfeeding are not available and animal reproduction studies have not been performed.

Based on evidence from clinical trials breastfeeding does not reduce the protection against rotavirus gastro-enteritis afforded by the vaccine. Breastfeeding may be continued during the vaccination schedule.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Apnoea
Cough
Decreased appetite
Dermatitis
Diarrhoea
Fever
Flatulence
Gastro-enteritis
Haematochezia
Intussusception
Irritability
Runny nose
Vomiting

Presentation

Oral vaccine containing human rotavirus RIX4414 strain (live, attenuated).

Drugs List

Therapeutic Indications

Uses

Active immunisation of infants against rotavirus infection

Active immunisation of infants aged 6 to 24 weeks for prevention of gastro-enteritis due to rotavirus infection.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Dosage

Children

Additional Dosage Information

Contraindications

Children under 6 weeks
Diarrhoea
Infants under 6 months exposed to immunosuppressive biological in utero
Patients over 24 weeks
Severe febrile conditions
Vomiting
Congenital malformation of the gastrointestinal tract
Hereditary fructose intolerance
History of intussusception
Severe Combined Immunodeficiency (SCID)

Precautions and Warnings

Immunosuppression
Infants exposed to immunosuppressive biological therapy via breast milk
Glucose-galactose malabsorption syndrome
Immunodeficiency syndromes

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Vaccine may not be effective in 100% of patients
Preparation contains sucrose
Strict hygiene near the immunocompromised:Longer viral presence in faeces
Establish full medical history and health status prior to vaccine
Risk of apnoea in premature infants - monitor respiration for 72 hours
Advise carer to report symptoms of intussusception
Follow national immunisation guidelines
Advise contacts of recent vaccinees of need for strict personal hygiene

There are no data on the safety and efficacy of the vaccine in infants with gastrointestinal illnesses or growth retardation. Administration of the vaccine may be considered with caution in such infants when withholding the vaccine entails a greater risk.

Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of the vaccine. Careful consideration of potential benefits and risks should be given when administering the rotavirus vaccine to infants who have known or suspected immunodeficiency.

Excretion of the vaccine virus in the stools is known to occur, with the peak excretion around the seventh day. Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccines have been observed without causing any clinical symptoms.

The potential risk of apnoea and the need for respiratory monitoring for 48h to 72h should be considered when administering the primary immunisation series to very premature infants (born after 27 weeks gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.

The vaccine does not protect against gastro-enteritis due to other pathogens than rotavirus.

No data are available on the use for post-exposure prophylaxis.

Pregnancy and Lactation

Pregnancy

The vaccine is not intended for use in adults.

Human data on use during pregnancy are not available and animal reproduction studies have not been performed.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

The vaccine is not intended for use in adults.

Human data on use during breastfeeding are not available and animal reproduction studies have not been performed.

Based on evidence from clinical trials breastfeeding does not reduce the protection against rotavirus gastro-enteritis afforded by the vaccine. Breastfeeding may be continued during the vaccination schedule.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Apnoea
Cough
Decreased appetite
Dermatitis
Diarrhoea
Fever
Flatulence
Gastro-enteritis
Haematochezia
Intussusception
Irritability
Runny nose
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: February 2018

Reference Sources

Summary of Product Characteristics: Rotarix Oral Applicator. GlaxoSmithKline UK. Revised April 2017.

Summary of Product Characteristics: Rotarix Tube. GlaxoSmithKline UK. Revised April 2017.

Immunisation against infectious diseases: 'The Green Book', Department of Health.
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book#the-green-book
Last accessed: 06 February 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 February 2018.