Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Moderate to severe chronic obstructive pulmonary disease (COPD) in patients who are not adequately treated by a combination of an inhaled corticosteriod and a long acting beta2-agonist or a combination of a long acting beta2-agonist and long acting muscarinic antagonist.

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Chronic infection
Uncontrolled systemic infection
Benign prostatic hyperplasia
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hypokalaemia
Lactose intolerance
Moderate hepatic impairment
Narrow angle glaucoma
Pregnancy
Pulmonary tuberculosis
Recent history of pneumonia
Severe cardiovascular disorder
Thyrotoxicosis
Unstable cardiac disorder
Urinary retention

Advise visual disturbances may affect ability to drive or operate machinery
Ensure patient has a fast acting bronchodilator available
Contains lactose
Check patient is using correct inhaler technique
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
May reduce serum potassium levels
Systemic effects possible with any inhaled corticosteroid
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Discontinue if symptoms of acute angle closure glaucoma occur
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Consider issuing Steroid Treatment/Steroid Emergency Card
High dose:Advise patient to avoid chickenpox,measles etc; see Dr if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone furoate, umeclidinium and vilanterol with caution during pregnancy.

The manufacturer recommends this medication is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies show reproductive toxicity, however exposures were not clinically relevant. There is little data available on the use of fluticasone furoate, umeclidinium and vilanterol in pregnant women. A potential risk cannot be ruled out.

Lactation

The combination of fluticasone furoate, umeclidinium and vilanterol is contraindicated during breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication. It is unknown whether fluticasone furoate, umeclidinium, vilanterol and their metabolites are excreted in human milk. Other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk, hence a risk to the infants cannot be excluded.

Side Effects

Anaphylaxis
Angioedema
Arthralgia
Atrial fibrillation
Back pain
Blurred vision
Bronchitis
Candidiasis (mouth or throat)
Constipation
Cough
Dry mouth
Dysphonia
Fractures
Headache
Hypersensitivity reactions
Influenza
Nasopharyngitis
Oropharyngeal pain
Pharyngitis
Pneumonia
Rash
Respiratory tract infection
Rhinitis
Sinusitis
Supraventricular tachycardia
Tachycardia
Upper respiratory tract infection
Urinary tract infections
Urticaria

Presentation

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

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Moderate to severe chronic obstructive pulmonary disease (COPD) in patients who are not adequately treated by a combination of an inhaled corticosteriod and a long acting beta2-agonist or a combination of a long acting beta2-agonist and long acting muscarinic antagonist.

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Galactosaemia

Precautions and Warnings

Chronic infection
Uncontrolled systemic infection
Benign prostatic hyperplasia
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
Hypokalaemia
Lactose intolerance
Moderate hepatic impairment
Narrow angle glaucoma
Pregnancy
Pulmonary tuberculosis
Recent history of pneumonia
Severe cardiovascular disorder
Thyrotoxicosis
Unstable cardiac disorder
Urinary retention

Advise visual disturbances may affect ability to drive or operate machinery
Ensure patient has a fast acting bronchodilator available
Contains lactose
Check patient is using correct inhaler technique
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs/symptoms of pneumonia in patients at risk
May reduce serum potassium levels
Systemic effects possible with any inhaled corticosteroid
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Discontinue if symptoms of acute angle closure glaucoma occur
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Consider issuing Steroid Treatment/Steroid Emergency Card
High dose:Advise patient to avoid chickenpox,measles etc; see Dr if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone furoate, umeclidinium and vilanterol with caution during pregnancy.

The manufacturer recommends this medication is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies show reproductive toxicity, however exposures were not clinically relevant. There is little data available on the use of fluticasone furoate, umeclidinium and vilanterol in pregnant women. A potential risk cannot be ruled out.

Lactation

The combination of fluticasone furoate, umeclidinium and vilanterol is contraindicated during breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication. It is unknown whether fluticasone furoate, umeclidinium, vilanterol and their metabolites are excreted in human milk. Other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk, hence a risk to the infants cannot be excluded.

Side Effects

Anaphylaxis
Angioedema
Arthralgia
Atrial fibrillation
Back pain
Blurred vision
Bronchitis
Candidiasis (mouth or throat)
Constipation
Cough
Dry mouth
Dysphonia
Fractures
Headache
Hypersensitivity reactions
Influenza
Nasopharyngitis
Oropharyngeal pain
Pharyngitis
Pneumonia
Rash
Respiratory tract infection
Rhinitis
Sinusitis
Supraventricular tachycardia
Tachycardia
Upper respiratory tract infection
Urinary tract infections
Urticaria

Further Information

Last Full Review Date: February 2021

Reference Sources

Summary of Product Characteristics: Trelegy Ellipta 92micrograms/55micrograms/22micrograms inhalation powder. GlaxoSmithKline UK. Revised September 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 02 February 2021