Drugs List

Therapeutic Indications

Uses

Asthma - prophylaxis
Chronic obstructive pulmonary disease (FEV1<70% predicted normal)

Regular treatment of asthma in patients:
Not controlled with inhaled corticosteroids and inhaled short acting beta2-agonists
Controlled on both inhaled corticosteroid and long-acting beta2-agonist

Chronic obstructive pulmonary disease (FEV1<70% predicted normal) with an exacerbation history despite regular bronchodilator therapy.

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Body mass index less than 25kg per square metre
Children aged 12 to 18 years
Elderly
Major risk factors for decreased bone mineral content
Tobacco smoking
Uncontrolled systemic infection
Adrenal insufficiency
Cardiac arrhythmias
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hypokalaemia
Lactose intolerance
Pregnancy
Pulmonary tuberculosis
Recent history of pneumonia
Severe cardiovascular disorder
Thyrotoxicosis

Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Advise visual disturbances may affect ability to drive or operate machinery
Ensure patient has a fast acting bronchodilator available
Not all available strengths are licensed for all indications
Not all strengths are suitable for use in children under 18 years
Contains lactose
Check patient is using correct inhaler technique
Consider adrenal suppression when transferring from systemic steroid
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor adrenal function in stressed patients e.g.surgery/intensive care
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor regularly the height of children receiving prolonged treatment
Advise patient to seek medical advice if asthma seems to be worsening
During transfer from oral steroids allergic conditions may be unmasked
High doses may cause adrenal suppression/bone metabolism changes
May reduce serum potassium levels
Patient should seek medical advice if signs of pulmonary infection develop
Systemic effects possible with any inhaled corticosteroid
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient not to reduce steroid therapy without medical advice
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Consider issuing Steroid Treatment/Steroid Emergency Card
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone furoate with vilanterol with caution in pregnancy.

The manufacturer notes that there is little information on the combined use of fluticasone furoate and vilanterol and that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus.

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 combination of fluticasone furoate with vilanterol is contraindicated in breastfeeding.

The manufacturer notes that a decision whether to discontinue breastfeeding or discontinue this medication must be made. There is insufficient information on the excretion of fluticasone furoate and vilanterol and/or their metabolites in human milk, hence a risk to the breastfed newborn/infant cannot be excluded.

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
Adrenal suppression
Aggression in children
Anaphylaxis
Angioedema
Anxiety
Arthralgia
Back pain
Behavioural disturbances
Blurred vision
Bronchitis
Candidiasis (mouth or throat)
Cataracts
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Dysphonia
Extrasystoles
Fractures
Glaucoma
Growth retardation (children)
Headache
Hyperglycaemia
Hypersensitivity reactions
Influenza
Muscle spasm
Nasopharyngitis
Oropharyngeal pain
Palpitations
Paradoxical bronchospasm (on inhalation)
Pharyngitis
Pneumonia
Psychological changes
Psychomotor hyperactivity
Pyrexia
Rash
Rhinitis
Sinusitis
Sleep disturbances
Tachycardia
Tremor
Upper respiratory tract infection
Urticaria
Visual disturbances

Presentation

Inhalation powder containing fluticasone furoate and vilanterol (as trifenatate).

Drugs List

Therapeutic Indications

Uses

Asthma - prophylaxis
Chronic obstructive pulmonary disease (FEV1<70% predicted normal)

Regular treatment of asthma in patients:
Not controlled with inhaled corticosteroids and inhaled short acting beta2-agonists
Controlled on both inhaled corticosteroid and long-acting beta2-agonist

Chronic obstructive pulmonary disease (FEV1<70% predicted normal) with an exacerbation history despite regular bronchodilator therapy.

Dosage

Patients usually experience an improvement in lung function within 15 minutes of inhaling this medication.

Adults

Children

Patients with Hepatic Impairment

Contraindications

Children under 12 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Body mass index less than 25kg per square metre
Children aged 12 to 18 years
Elderly
Major risk factors for decreased bone mineral content
Tobacco smoking
Uncontrolled systemic infection
Adrenal insufficiency
Cardiac arrhythmias
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hypokalaemia
Lactose intolerance
Pregnancy
Pulmonary tuberculosis
Recent history of pneumonia
Severe cardiovascular disorder
Thyrotoxicosis

Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Advise visual disturbances may affect ability to drive or operate machinery
Ensure patient has a fast acting bronchodilator available
Not all available strengths are licensed for all indications
Not all strengths are suitable for use in children under 18 years
Contains lactose
Check patient is using correct inhaler technique
Consider adrenal suppression when transferring from systemic steroid
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor adrenal function in stressed patients e.g.surgery/intensive care
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor regularly the height of children receiving prolonged treatment
Advise patient to seek medical advice if asthma seems to be worsening
During transfer from oral steroids allergic conditions may be unmasked
High doses may cause adrenal suppression/bone metabolism changes
May reduce serum potassium levels
Patient should seek medical advice if signs of pulmonary infection develop
Systemic effects possible with any inhaled corticosteroid
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient not to reduce steroid therapy without medical advice
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patients to avoid chickenpox, measles etc - see doctor if exposed
Consider issuing Steroid Treatment/Steroid Emergency Card
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone furoate with vilanterol with caution in pregnancy.

The manufacturer notes that there is little information on the combined use of fluticasone furoate and vilanterol and that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus.

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 combination of fluticasone furoate with vilanterol is contraindicated in breastfeeding.

The manufacturer notes that a decision whether to discontinue breastfeeding or discontinue this medication must be made. There is insufficient information on the excretion of fluticasone furoate and vilanterol and/or their metabolites in human milk, hence a risk to the breastfed newborn/infant cannot be excluded.

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
Adrenal suppression
Aggression in children
Anaphylaxis
Angioedema
Anxiety
Arthralgia
Back pain
Behavioural disturbances
Blurred vision
Bronchitis
Candidiasis (mouth or throat)
Cataracts
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Dysphonia
Extrasystoles
Fractures
Glaucoma
Growth retardation (children)
Headache
Hyperglycaemia
Hypersensitivity reactions
Influenza
Muscle spasm
Nasopharyngitis
Oropharyngeal pain
Palpitations
Paradoxical bronchospasm (on inhalation)
Pharyngitis
Pneumonia
Psychological changes
Psychomotor hyperactivity
Pyrexia
Rash
Rhinitis
Sinusitis
Sleep disturbances
Tachycardia
Tremor
Upper respiratory tract infection
Urticaria
Visual disturbances

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

Summary of Product Characteristics: Relvar Ellipta 92 micrograms/22 micrograms inhalation powder. GlaxoSmithKline UK. Revised September 2018.

Summary of Product Characteristics: Relvar Ellipta 184 micrograms/22 micrograms inhalation powder. GlaxoSmithKline UK. Revised September 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 July 2018