Drugs List

Therapeutic Indications

Uses

Influenza - prophylaxis

Prophylaxis of influenza in individuals aged 24 months to 18 years.

Administration

The vaccine is administered as a divided dose in both nostrils.

After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.

The patient can breathe normally while the vaccine is being administered. There is no need to actively inhale or sniff.

Contraindications

Children under 2 years
Immunosuppression
Patients over 18 years
Within 48 hours of discontinuing influenza antiviral agents
Breastfeeding
Immunodeficiency syndromes
Pregnancy

Precautions and Warnings

HIV infection without clinical manifestation
Severe asthma

Egg allergy: Use products containing less than 120 nanograms/ml ovalbumin
Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Theoretical risk of transmission of live virus to susceptible contacts
Follow national immunisation guidelines
Avoid contact with susceptible individuals for 1-2 weeks after vaccination

Except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with influenza vaccine nasal spray in any setting (including primary care and schools); those with clinical risk factors that contraindicate influenza vaccine nasal spray should be offered an inactivated influenza vaccine with a very low ovalbumin content (less than 120 nanograms/ml). Children with a history of severe anaphylaxis to egg which has previously required intensive care, should be referred to specialists for immunisation in hospital.

Vaccine recipients should attempt to avoid close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1 to 2 weeks following vaccination. Where this is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.

Pregnancy and Lactation

Pregnancy

Influenza nasal vaccine is contraindicated in pregnancy.

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

Influenza nasal vaccine is contraindicated in breastfeeding.

It is not known if influenza virus is excreted in human breast milk. Some viruses are excreted into human milk, but the vaccine is heat sensitive and does not survive in the plasma or milk and therefore limited risk to the infant. Some sources suggest influenza nasal vaccine is compatible with breastfeeding however the manufacturer advises it should not be used.

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

Anaphylactic reaction
Decreased appetite
Epistaxis
Facial oedema
Guillain-Barre syndrome
Headache
Hypersensitivity reactions
Leigh syndrome
Malaise
Myalgia
Nasal congestion
Pyrexia
Rash
Rhinorrhoea
Urticaria

Presentation

Nasal spray vaccine containing influenza virus (live, attenuated).

This product has been produced by reverse genetic technology using VERO cells.

Drugs List

Therapeutic Indications

Uses

Influenza - prophylaxis

Prophylaxis of influenza in individuals aged 24 months to 18 years.

Dosage

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

Children

Administration

The vaccine is administered as a divided dose in both nostrils.

After administering half of the dose in one nostril, administer the other half of the dose in the other nostril immediately or shortly thereafter.

The patient can breathe normally while the vaccine is being administered. There is no need to actively inhale or sniff.

Contraindications

Children under 2 years
Immunosuppression
Patients over 18 years
Within 48 hours of discontinuing influenza antiviral agents
Breastfeeding
Immunodeficiency syndromes
Pregnancy

Precautions and Warnings

HIV infection without clinical manifestation
Severe asthma

Egg allergy: Use products containing less than 120 nanograms/ml ovalbumin
Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Theoretical risk of transmission of live virus to susceptible contacts
Follow national immunisation guidelines
Avoid contact with susceptible individuals for 1-2 weeks after vaccination

Except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with influenza vaccine nasal spray in any setting (including primary care and schools); those with clinical risk factors that contraindicate influenza vaccine nasal spray should be offered an inactivated influenza vaccine with a very low ovalbumin content (less than 120 nanograms/ml). Children with a history of severe anaphylaxis to egg which has previously required intensive care, should be referred to specialists for immunisation in hospital.

Vaccine recipients should attempt to avoid close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1 to 2 weeks following vaccination. Where this is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.

Pregnancy and Lactation

Pregnancy

Influenza nasal vaccine is contraindicated in pregnancy.

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

Influenza nasal vaccine is contraindicated in breastfeeding.

It is not known if influenza virus is excreted in human breast milk. Some viruses are excreted into human milk, but the vaccine is heat sensitive and does not survive in the plasma or milk and therefore limited risk to the infant. Some sources suggest influenza nasal vaccine is compatible with breastfeeding however the manufacturer advises it should not be used.

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

Anaphylactic reaction
Decreased appetite
Epistaxis
Facial oedema
Guillain-Barre syndrome
Headache
Hypersensitivity reactions
Leigh syndrome
Malaise
Myalgia
Nasal congestion
Pyrexia
Rash
Rhinorrhoea
Urticaria

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: July 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Fluenz Tetra nasal spray suspension Influenza vaccine (live attenuated, nasal). AstraZeneca UK Limited. Revised March 2018.

Immunisation against infectious disease - The Green Book.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 03 July 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 July 2018

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Influenza vaccine. Last revised: 11 April 2017.
Last accessed: 03 July 2018.