Fluticasone Furoate/ Vilanterol

Registered South African indications:

• Asthma
• Chronic obstructive pulmonary disease

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe milk-protein allergy

Cautions

• Pregnancy
• Breastfeeding
• Hepatic impairment
• Acute asthma
• Severe cardiovascular disease 
• Cardiac rhythm abnormalities
• Thyrotoxicosis
• Uncorrected hypokalaemia 
• Patients predisposed to low levels of serum potassium
• Pulmonary tuberculosis
• Patients with chronic or untreated infections
• High doses
• Prolonged duration
• History of diabetes mellitus
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption 

Forms avail. in SA and covered in this monograph: inh

Asthma
- Maintenance and preventive treatment of asthma

Fluticasone Furoate/ Vilanterol
92/22 (μg)
184/22 (μg)

• Inhaled (inh): 1 inhalation, daily either morning or evening but at the same time every day

Asthma: 
Patients should be made aware that fluticasone furoate/ vilanterol must be used regularly, even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief. Patients should be regularly re-assessed by a healthcare professional so that the strength of fluticasone furoate/ vilanterol they are receiving remains optimal and is only changed on medical advice

A starting dose of fluticasone furoate/ vilanterol 92/22 (μg) should be considered for patients who require a low to mild dose of inhaled corticosteroid in combination with a long acting beta₂-agonist. Fluticasone furoate/ vilanterol 184/22 (μg) should be considered for patients who require a higher dose of inhaled corticosteroid in combination with a long acting beta₂-agonist

If patients are inadequately controlled on fluticasone furoate/ vilanterol 92/22 (μg) consider increasing the dose to fluticasone furoate/ vilanterol 184/22 (μg), which may provide additional improvement in asthma control

Chronic obstructive pulmonary disease (COPD)
- Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with an exacerbation history

Fluticasone Furoate/ Vilanterol
92/22 (μg)

• Inhaled (inh): 1 inhalation, daily either morning or evening but at the same time every day

Fluticasone furoate/ vilanterol 184/22 (μg) is not indicated for patients with COPD

All indications:
For inhalation only.  After inhalation, patients should rinse their mouth with water without swallowing

Not established for use in children below 12 years

Pregnancy

• Caution
• Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant. There are no or limited data from the use of fluticasone furoate and vilanterol trifenatate in pregnant women
• Administration of fluticasone furoate/vilanterol to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus

Breastfeeding

• Caution 
• There is insufficient information on the excretion of fluticasone furoate or vilanterol trifenatate and/or metabolites in human milk. However, other corticosteroids and beta-2 agonists are detected in human milk. A risk to breastfed newborns/infants cannot be excluded
• A decision must be made whether to discontinue breastfeeding or to discontinue fluticasone furoate/vilanterol therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Mild: Caution; no dose adjustment recommended
• Moderate to severe: Caution; dose adjustment recommended
  Max dose: 92/22 (μg)

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Prohibited - At all times

Central Nervous System Disorders

• Headache
• Tremor
• Anxiety

Cardiovascular Disorders

• Extrasystoles
• Palpitations
• Tachycardia

Respiratory Disorders

• Nasopharyngitis
• Paradoxical bronchospasm
• Oropharyngeal pain
• Sinusitis
• Pharyngitis
• Rhinitis
• Cough
• Dysphonia
• Pneumonia
• Upper respiratory tract infection
• Bronchitis

Gastrointestinal Disorders

• Abdominal pain

Musculoskeletal Disorders

• Arthralgia
• Back pain
• Fractures
• Muscle spasms

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions 
• Influenza
• Candidiasis of mouth and throat
• Pyrexia

• Beta blockers 
• CYP3A4 inhibitors
• Other long-acting beta-2 agonists
• Sympathomimetic agents

• Pulmonary function tests
• Bone mineral density 
• Vital signs

Specific cases may require

• Serum potassium 
• Blood glucose
• Ophthalmic examination

Fluticasone Furoate
Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which fluticasone furoate affects asthma and chronic obstructive pulmonary disorder symptoms is not known. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines involved in inflammation).

Vilanterol
Vilanterol trifenatate is a selective long-acting, beta-2 adrenergic agonist (LABA). The pharmacologic effects of beta-2 adrenoceptor agonists, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Molecular interactions occur between corticosteroids and LABAs, whereby steroids activate the beta-2 receptor gene, increasing receptor number sensitivity; and LABAs prime the glucocorticoid receptor for steroid-dependent activation and enhance cell nuclear translocation.

COMBINATION PREPARATIONS

Fluticasone Furoate/ Vilanterol

Inhaler 92μg/22μg

• Relvar Ellipta (GSK) originator

Inhaler 184μg/22μg

• Relvar Ellipta (GSK) originator