Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW
This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
Or
Flutiform 50 microgram/5 microgram inhaler is indicated in adults, adolescents and children aged 5 years and above.
Flutiform 125 microgram/5 microgram inhaler is indicated in adults and adolescents aged 12 years and above.
Flutiform 250 microgram/10 microgram inhaler is indicated in adults only.
Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once control of asthma is achieved with the lowest strength of Flutiform inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important.
There are no data available for use of Flutiform inhaler in patients with COPD. Flutiform inhaler should not be used in patients with COPD.
Patients should be given the strength of Flutiform inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Flutiform 50 microgram/5 microgram per actuation, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β2 agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed.
Flutiform inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses).
Flutiform 50 microgram/5 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
For adults and adolescents:
If the patient’s asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product – i.e. Flutiform 125 microgram/5 microgram inhaler – two inhalations (puffs) twice daily. This strength should not be used in children under the age of 12 years.
For adults only:
The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents and children.
Experience in children under the age of 5 years is limited (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform inhaler in any strength is not recommended for use in children less than 5 years of age; Flutiform inhaler should not be used in this young age group.
Flutiform 125 microgram/5 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Patients may be transferred to the lowest strength of this combination product i.e. Flutiform 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained
For adults only:
The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily. This highest strength is for use in adults only; it should not be used in adolescents aged 12 years and above.
No data are available for this strength of Flutiform inhaler in children. Experience in children under the age of 12 years is limited to the lowest strength (50 microgram/5 microgram) (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform inhaler in this strength (125 microgram/5 microgram) is not recommended for use in children less than 12 years of age; Flutiform inhaler 125 microgram/5 microgram per actuation should not be used in this young age group.
Flutiform 250 microgram/10 microgram inhaler – two inhalations (puffs) twice daily normally taken in the morning and in the evening.
Patients may be transferred to a lower strength of this combination product i.e. Flutiform 125 microgram/5 microgram inhaler or ultimately Flutiform 50 microgram/5 microgram inhaler if their asthma is adequately controlled. A patient’s dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
No data are available for this strength of Flutiform inhaler in children or adolescents. Experience in children is limited to the lowest strength (50 microgram/5 microgram) (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform inhaler in this strength (250 microgram/10 microgram) is not recommended for use in adolescents or children; Flutiform inhaler 250 microgram/10 microgram per actuation should not be used in this young age group.
Flutiform inhaler 250 microgram/10 microgram per actuation should not be used in adolescents or children. However there are lower strengths available i.e. 50 microgram/5 microgram per actuation which may be used in children or adolescents or 125 microgram/5 microgram per actuation which may be used in adolescents.
There is no need to adjust the dose in elderly patients.
There are no data available for use of Flutiform inhaler in patients with hepatic or renal impairment (see section 5.2). These patients should be regularly monitored by a physician to ensure titration to the lowest dose at which effective control of symptoms is maintained. As the fractions of fluticasone and formoterol which reach systemic circulation are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe hepatic impairment.
Inhaled corticosteroids alone are the first line of treatment for most patients. Flutiform inhaler is not intended for the initial treatment of mild asthma. For patients with severe asthma the inhaled corticosteroid therapy should be established before prescribing a fixed-dose combination product.
Patients should be made aware that Flutiform inhaler must be used daily for optimum benefit, even when asymptomatic.
Patients using Flutiform inhaler should not use additional long-acting β2 agonists for any reason. If asthma symptoms arise in the period between doses, an inhaled, short-acting β2 agonist should be taken for immediate relief.
For patients who are currently receiving medium to high doses of inhaled corticosteroid therapy, and whose disease severity clearly warrants treatment with two maintenance therapies, the recommended starting dose is two inhalations twice daily of Flutiform 125 microgram /5 microgram inhaler.
Use of a spacer device with Flutiform inhaler is recommended in patients who find it difficult to synchronise aerosol actuation with inspiration of breath. The AeroChamber Plus Flow-Vu is the recommended spacer device.
Patients should be instructed in the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled drug to the lungs.
Re-titration to the lowest effective dose should always follow the introduction of a spacer device.
For inhalation use.
To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professionals. The correct use of the pressurised metered dose inhaler (pMDI) is essential for successful treatment. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use and pictograms in the leaflet.
The actuator has an integrated counter which counts down the number of actuations (puffs) remaining. This counter is also colour coded. It starts off green then, when there are less than 50 puffs (actuations) left it changes to yellow and when there are less than 30 puffs (actuations) left it changes to red. The counter counts down from 120 to 60 in intervals of 10, and from 60 to 0 in intervals of 5. When this is getting near to zero the patient should be advised to contact their prescriber for a replacement inhaler. The inhaler must not be used after the dose indicator reads “0”.
Before using the inhaler for the first time, or if the inhaler has not been used for 3 days or more, or after exposure to freezing or refrigerated conditions (see section 6.4) the inhaler must be primed before use:
Whenever possible patients should stand or sit in an upright position when inhaling from the inhaler.
Steps to follow when using the inhaler:
IMPORTANT: Do not perform steps 2 to 6 too quickly.
Patients may be advised to practise their technique in front of a mirror. If a mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.
Patients should rinse their mouth, gargle with water or brush the teeth after inhaling and spit out the residue to minimise the risk of oral candidiasis or dysphonia.
Cleaning:
Patients should be advised to read the Patient Information Leaflet carefully for cleaning instructions:
The inhaler should be cleaned once a week.
If a patient requires an AeroChamber Plus/Flow-Vu spacer device then they must be advised to read the instructions provided by the manufacturer to ensure they use it and clean and maintain it properly.
There are no data available from clinical trials on overdose with Flutiform inhaler, however, data on overdose with both single drugs are given below:
An overdose of formoterol would likely lead to an exaggeration of effects that are typical for β2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.
Treatment of formoterol overdose consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of cardio selective β receptor blockers may be considered, bearing in mind that such medication can induce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial in cases of formoterol overdose. Cardiac monitoring is recommended.
If Flutiform inhaler therapy has to be withdrawn due to overdose of the β agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Serum potassium levels should be monitored as hypokalaemia can occur. Potassium replacement should be considered.
Acute overdose with fluticasone propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.
There are reports of rare cases of acute adrenal crisis. Children and adolescents <16 years taking high doses of fluticasone propionate: (typically ≥1000 microgram/day) may be at particular risk. Presenting symptoms can be vague (anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting and hypotension). Typical symptoms of an adrenal crisis are decreased level of consciousness, hypoglycaemia and/or seizures.
Following chronic use of very high doses a degree of atrophy of the adrenal cortex and HPA axis suppression may occur. Monitoring of adrenal reserve may be necessary. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see section 4.4).
In the management of chronic overdose oral or systemic corticosteroids may be required in situations of stress. All patients deemed to be chronically overdosed should be treated as if steroid dependent with a suitable maintenance dose of a systemic corticosteroid. When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose for symptom control.
2 Years.
In use shelf – life: 3 months after opening the foil pouch.
Do not store above 25°C. Do not refrigerate or freeze. If the inhaler is exposed to freezing conditions then the patient must be advised to allow the inhaler to warm at room temperature for 30 minutes then re-prime the inhaler (see section 4.2).
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn, even when apparently empty.
120 actuations per inhaler.
The actuator is white with a grey integrated dose indicator and a light grey mouthpiece cover. The suspension is contained in an aluminium pressurised canister crimped with a standard metering valve. This canister is inserted into a press-and-breathe actuator fitted with a mouthpiece cover (both made of polypropylene) and an integrated dose indicator which indicates the number of actuations (puffs) remaining. Each container delivers 120 actuations. The assembled MDI inhaler is pouched in an aluminium foil laminate and is packed in a cardboard carton.
Pack sizes:
1 inhaler (120 actuations)
multipack of 3 × 1 inhaler (120 actuations)
Not all pack sizes may be marketed.
No special requirements for disposal.
For detailed instructions on the use of the medicinal product see section 4.2.
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