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Fobumix Easyhaler (budesonide / formoterol fumarate dihydrate)

Product info | 04/12/2019
Fobumix Easyhaler (budesonide / formoterol fumarate dihydrate)

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FOBUMIX EASYHALER®
(budesonide/formoterol fumarate dihydrate)

Full prescribing information can be found here

 

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COMPOSITIONS:

  • budesonide/formoterol fumarate dihydrate

STRENGTHS:

  • 80/4.5mcg
  • 160/4.5mcg
  • 320/9mcg

METERED DOSE:
The mass of drug that is available within the aerosol generator per actuation. 

DELIVERED DOSE:
The mass of drug emitted per actuation that is actually available for inhalation at the mouth.

For Fobumix Easyhaler® the delivered dose and the metered dose are the same. However, for Symbicort Turbohaler® the delivered dose and the metered dose are different. For example, Symbicort Turbohaler® 100/6 and Fobumix Easyhaler® 80/4.5 deliver the equivalent dose to the patient, however, Symbicort Turbohaler® is labelled with the metered dose. 

INDICATIONS (FOR ADULTS ONLY):
Not intended for the initial management of asthma.

Asthma: Maintenance Therapy - For patients aged 18 years and over

STRENGTH INDICATIONS
80/4.5mcg Regular treatment of asthma where the use of a combination (inhaled corticosteroid and long-acting beta-2-adrenoceptor agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta-2-adrenoceptor agonists or patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-adrenoceptor agonists
160/4.5mcg
320/9mcg

 

Asthma: Maintenance And Reliever Therapy (MART) - For patients aged 18 years and over

STRENGTH INDICATIONS
80/4.5mcg Regular treatment of asthma where the use of a combination (inhaled corticosteroid and long-acting beta-2-adrenoceptor agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta-2-adrenoceptor agonists or patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-adrenoceptor agonists
160/4.5mcg
320/9mcg This strength is not indicated for MART

 

COPD - For patients aged 18 years and over

STRENGTH INDICATIONS
80/4.5mcg This strength is not indicated for COPD
160/4.5mcg Symptomatic treatment of adults (18 years and older) with COPD with FEV1 < 70% predicted normal (post-bronchodilators) and an exacerbation history despite regular bronchodilator therapy
320/9mcg

 

CONTRAINDICATIONS:
Fobumix Easyhaler® is contraindicated for patients with hypersensitivity to the active substances or lactose monohydrate (which contains milk proteins)

 

UNDESIRABLE EFFECTS:
Pharmacological side effects of beta-2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.

Very Common side effects include: headache, nasopharyngitis.

Common side effects include: candidiasis of the mouth and throat, pneumonia (in COPD patients), bronchitis, hypokalaemia, throat irritation, hoarseness/dyspnoea, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalgia.

Prescribers should consult the SmPC in relation to special warnings and precautions.

 

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CONSISTENT DOSING EVEN WITH LOW PATIENT INHALATION FLOW:
Fobumix Easyhaler® provides more accurate and consistent dose delivery vs Turbohaler across different patient inhalation flow rates (p<0.001, Figure 1). The dose delivery remains consistent throughout the inhaler lifespan, and is not affected by environmental stress, such as moisture, dropping, vibration, or repeated freeze-thaw cycles. Fobumix Easyhaler® ensures accurate and consistent dosing, starting from a peak inspiratory flow (PIF) of 30 L/min.2,3

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Figure 1: Adapted from Haikarainen et al., 2017. Fobumix Easyhaler® offers consistent dosing even with low patient inhalation flows

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Titration to the lowest effective dose could include once daily use, when a long acting bronchodilator and inhaled corticosteroid would be required to maintain control. Children: not indicated for use in children and adolescents (13-17 yrs).1

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INDICATION:1
Fobumix Easyhaler® 80/4.5mcg & 160/4.5mcg are indicated for Maintenance and Reliever
Therapy (MART) in asthma for patients 18 years of age and over.

Fobumix Easyhaler® 320/9 is not indicated for Maintenance and Reliever Therapy.

 

HOW DOES MART WORK?

Formoterol, in addition to its dose-dependent bronchodilating effect,
has a rapid onset of action of 1-3 minutes


The fast-acting formoterol in the ICS/LABA combination means patients are not required
to have an additional SABA as they can get fast acting relief with just the single inhaler.

 

DOSING WITH MART

USUAL DOSING:

80/4.5mcg
fobumix-small-pack.jpg 2 inhalations per day, given as a single or divided dose + as needed inhalations
160/4.5mcg
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2 inhalations per day, given as a single or divided dose + as needed inhalations


A maximum 6 inhalations on any single occasion may be taken.

A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.

For some patients on the 160/4.5 strength only, 2 maintenance inhalations twice daily may be appropriate.

Fobumix Easyhaler® 320/9 is not indicated for Maintenance and Reliever Therapy

 

WHAT COULD THE USUAL DOSING REGIMEN LOOK LIKE FOR A PATIENT?

A hypothetical example illustrating a possible dosing regimen for a patient using Fobumix
Easyhaler® 80/4.5mcg or 160/4.5mcg. The example demonstrates a patient taking their
Fobumix Easyhaler® twice per day as a divided dose for their maintenance treatment, as well as
also taking additional inhalations of their Fobumix Easyhaler® as needed throughout the day to
relieve their symptoms.

 

COMPREHENSIVE CARE – IMPROVED ASTHMA CONTROL
Fobumix Easyhaler® combines both maintenance and reliever therapy (MART) within a single
inhaler device. Patients treated with budesonide/formoterol as part of a MART regimen
experience less asthma exacerbations compared to those receiving fixed-dose therapy in
individual devices with as needed terbutaline or formoterol (p<0.0001).1,4

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EXPERIENCING LIFE WITH FEWER SYMPTOMS
Fobumix Easyhaler® significantly improves asthma and COPD-related quality of life (mini-AQLQ,
mMRC dyspnea scale, p<0.001).

Figure 2: Adapted from Tamási et al., 2018. Fobumix Easyhaler® combination therapy improves asthma and COPD control. N (total) = 1498 patients (621 with asthma, 778 with COPD, and 99 with asthma-COPD overlap; 455 newly diagnosed and 1043 patients switching from another inhaler device). *P<0.001 for average ACT and CAT score.
**Impact of COPD symptoms on everyday life. Patients received 12 weeks of Fobumix Easyhaler therapy.5

 

†This article refers to UK brand names. Within the clinical papers the brand names reflect the
location of where the studies took place.

 

COPD = Chronic obstructive pulmonary disease, ICS = Inhaled corticosteroid, SABA = Short
acting beta agonist, LABA = Long acting beta agonist, ICS + LABA = Inhaled corticosteroid +
long acting beta agonist.

 

June 2021/RESP-330bba(2)

 

REFERENCES:

  1. Fobumix Easyhaler® 80/4.5, 160/4.5, and 320/9 mcg. SmPC. Orion Pharma.
  2. Haikarainen J, Selroos O, Löytänä T, Metsärinne S, Happonen A, Rytila P. Budesonide/Formoterol Easyhaler®: Performance under simulated real-life conditions. Pulm
    Ther 2017;3:125–38.
  3. Ghosh S, Ohar J, Drummond M. Peak inspiratory flow rate in chronic obstructive pulmonary
    disease: implications for dry powder inhalers. J Aerosol Pulm Drug Deliv 2017;30(6):381–87.
  4. Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and
    reliever therapy on asthma exacerbations. Int J Clin Pract, May 2007,61,5,725–736.
  5. Tamási L, Szilasi M, Gálffy G. Clinical eectiveness of budesonide/formoterol fumarate
    Easyhaler® for patients with poorly controlled obstructive airway disease: a real-world study
    of patient-reported outcomes. Adv Ther 2018;35(8):1140–52.

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Orion Pharma (UK) Ltd on 01635 520300.

ORIONPHARMA.CO.UK

 

Full prescribing information available here

 

MAY 2021 / RESP-330b(3)

 

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Orion Pharma (UK) Ltd on 01635 520300.

Orion Pharma (UK) Ltd, Abbey Gardens, 4 Abbey Street, Reading, RG1 3BA, UK | Tel: +44 1635 520 300 | February 2021 / RESP-330(1)
Policies Contact us Orion Corporation 2021