Glucocorticoids - ATC code: R03BA01

beclometasone dipropionate

Beclometasone Dipropionate 50 micrograms per metered (ex-valve) dose. (The dose delivered from the mouthpiece is an average 37.5 micrograms)

Pressurised inhalation, solution. A colourless solution in a pressurised aluminium canister fitted with a metering valve and an actuator. Qvar Easi-Breathe contains a propellant, which does not contain any chlorofluorocarbons (CFCs)

Prophylactic management of mild, moderate or severe asthma.

Qvar Easi-Breathe is for inhalation use only.

Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use. Patients should be advised that Qvar may have a different taste and feel than a CFC inhaler.

NOTE: The recommended total daily dose of Qvar Easi-Breathe is lower than that for current beclometasone dipropionate CFC containing products and should be adjusted to the needs of the individual patient.

ADULT STARTING AND MAINTENANCE DOSE:

It is important to gain control of asthma symptoms and optimise pulmonary function as soon as possible. When patients' symptoms remain under satisfactory control, the dose should be titrated to the lowest dose at which effective control of asthma is maintained.

To be effective, inhaled Qvar Easi-Breathe must be used on a regular basis even when patients are asymptomatic.

THERAPY IN NEW PATIENTS SHOULD BE INITIATED AT THE FOLLOWING DOSAGES

TRANSFERRING PATIENTS TO QVAR EASI-BREATHE FROM A CFC-CONTAINING INHALER

The general approach to switching patients to Qvar Easi-Breathe involves two steps as detailed below. Specific guidance on switching well-controlled and poorly-controlled (symptomatic) patients is given below the table.

Step 1: Consider the dose of CFC containing beclometasone dipropionate product appropriate to the patient's current condition.

Step 2: Convert the CFC containing beclometasone dipropionate dose to the Qvar Easi-Breathe dose according to the table below.

*CFC-BDP = CFC beclometasone dipropionate

1. Dosing in well-controlled patients with asthma

Patients with well-controlled asthma using beclometasone dipropionate CFC containing product should be switched to Qvar Easi-Breathe at a dose in accordance with the table above.

For example:

Patients on 2 puffs twice daily of CFC beclometasone dipropionate 100 micrograms would change to 2 puffs twice daily of Qvar Easi-Breathe 50 micrograms.

2. Dosing in poorly-controlled (symptomatic) patients with asthma

Patients with poorly-controlled asthma may be switched from CFC containing beclometasone dipropionate products to Qvar Easi-Breathe at the same microgram for microgram dose up to 800 micrograms daily. Comparative clinical studies have demonstrated that asthma patients achieve equivalent pulmonary function and control of symptoms with Qvar aerosol (an equivalent inhaler) at lower total daily doses than with CFC containing beclometasone dipropionate products.

Alternatively the patient's current CFC containing beclometasone dipropionate dose can be doubled and this dose can be converted to the Qvar Easi-Breathe dose according to the table above.

Patients on budesonide inhalers may be transferred to Qvar Easi-Breathe as described for CFC containing beclometasone dipropionate products.

Patients on fluticasone inhalers may be transferred to the same total daily dose of Qvar Easi-Breathe up to 800 micrograms daily.

Once transferred to Qvar Easi-Breathe the dose should be adjusted to meet the needs of the individual patient.

The maximum recommended dose is 800 micrograms per day in divided doses.

The same total daily dose in micrograms from either Qvar Easi-Breathe 50 or Qvar Easi-Breathe 100 (a higher strength) Inhaler provides the same clinical effect.

Patients should be instructed in the proper use of their inhaler, including rinsing out their mouth with water after use. Patients should be advised that Qvar Easi-Breathe may have a different taste and feel than a CFC inhaler.

SPECIAL PATIENT GROUPS

No special dosage recommendations are made for elderly or patients with hepatic or renal impairment.

There are no data to date on Qvar Easi-Breathe in children under 12 years of age, hence no definitive dosage recommendation can be made.

No special dosage recommendations are made for elderly or patients with hepatic or renal impairment.

Hypersensitivity to beclometasone dipropionate or to any of the excipients.

To be effective, Qvar Easi-Breathe must be used by patients on a regular basis, even when patients do not have asthma symptoms. When symptoms are controlled, maintenance Qvar Easi-Breathe therapy should be reduced in a stepwise manner to the minimum effective dose. Inhaled steroid treatment should not be stopped abruptly. Patients with asthma are at risk of acute attacks and should have regular assessments of their asthma control including pulmonary function tests.

Qvar Easi-Breathe is not indicated for the immediate relief of asthma attacks. Patients therefore need to have relief medication (inhaled short-acting bronchodilator) available for such circumstances.

Qvar Easi-Breathe is not indicated in the management of status asthmaticus.

Severe asthma exacerbations should be managed in the usual way. Subsequently, it may be necessary to increase the dose of Qvar Easi-Breathe up to the maximum daily dose. Systemic steroid treatment may be needed and/or an antibiotic, if there is an infection.

Patients should be advised to seek medical attention for review of maintenance Qvar Easi-Breathe therapy if peak flow falls, symptoms worsen or if the short-acting bronchodilator becomes less effective and increased inhalations are required. This may indicate worsening asthma.

Patients who have received systemic steroids for long periods of time or at high doses, or both, need special care and subsequent management when being transferred to inhaled steroid therapy. Patients should have stable asthma before being given inhaled steroids in addition to the usual maintenance dose of systemic steroid. Withdrawal of systemic steroids should be gradual, starting about seven days after the introduction of Qvar Easi-Breathe therapy. For daily oral doses of prednisolone of 10mg or less, dose reduction in 1mg steps, at intervals of not less than one week is recommended. For patients on daily maintenance doses of oral prednisolone greater than 10mg, larger weekly reductions in the dose might be acceptable. The dose reduction scheme should be chosen to correlate with the magnitude of the maintenance systemic steroid dose.

Most patients can be successfully transferred to inhaled steroids with maintenance of good respiratory function, but special care is necessary for the first few months after the transfer, until the hypothalamic-pituitary-adrenal (HPA) system has sufficiently recovered to enable the patient to cope with stressful emergencies such as trauma, surgery or serious infections. Patients should, therefore, carry a steroid warning card to indicate the possible need to re-instate systemic steroid therapy rapidly during periods of stress or where airways obstruction or mucus significantly compromises the inhaled route of administration. In addition, it may be advisable to provide such patients with a supply of corticosteroid tablets to use in these circumstances. The dose of inhaled steroids should be increased at this time and then gradually reduced to the maintenance level after the systemic steroid has been discontinued. As recovery from impaired adrenocortical function, caused by prolonged systemic steroid therapy is slow, adrenocortical function should be monitored regularly.

Patients should be advised that they may feel unwell in a non-specific way during systemic steroid withdrawal despite maintenance of, or even improved respiratory function. Patients should be advised to persevere with their inhaled product and to continue withdrawal of systemic steroids, even if feeling unwell, unless there is evidence of HPA axis suppression.

Discontinuation of systemic steroids may also cause exacerbation of allergic diseases such as atopic eczema and rhinitis. These should be treated as required with topical therapy, including corticosteroids and/or antihistamines.

Beclometasone dipropionate, like other inhaled steroids, is absorbed into the systemic circulation from the lungs. Beclometasone dipropionate and its metabolites may exert detectable suppression of adrenal function. Within the dose range 100-800 micrograms daily, clinical studies with Qvar aerosol (an equivalent inhaler) have demonstrated mean values for adrenal function and responsiveness within the normal range. However, systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma, and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained.

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.

Like other corticosteroids, caution is necessary in patients with active or latent pulmonary tuberculosis.

No interaction studies have been performed.

A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.

As with other inhaled therapy, paradoxical bronchospasm may occur after dosing. Immediate treatment with a short-acting bronchodilator should be initiated, Qvar should be discontinued immediately and an alternate prophylactic treatment introduced.

Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children, decrease in bone mineral density and the occurrence of cataract and glaucoma.

Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth may occur. To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler.

Based on the MedDra system organ class and frequencies, adverse events are listed in the table below according to the following frequency estimate: very common ( 1/10); common (1/100 to <1/10); Uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Teva UK Limited

(POM)

14 February 2012