Frequently asked questions

Frequently Asked Questions cover a diverse range of subjects, including evidence from the SPIOLTO®RESPIMAT® clinical trial programme, prescribing guidelines for SPIOLTO® RESPIMAT® and the administration of SPIOLTO® via the RESPIMAT® inhaler.

Administration of SPIOLTO® RESPIMAT®

How do you use SPIOLTO® RESPIMAT® (Assembly, Priming, and Daily Dosing)?

Please follow this link on how to use SPIOLTO® RESPIMAT® or view the first-time use and daily use instructions in the SmPC.

Why does the inhaler need to be primed before first use?

RESPIMAT® works mechanically, without a propellant. Before the first use, the solution with the medication needs to be drawn up through a tube. This will ensure patients get the full dose. Priming does not affect the number of doses available in the inhaler.

How does the dose indicator work?

The dose indicator shows how many puffs of medicine are left. When the pointer enters the red area of the scale, there is approximately enough medication left for 7 days. This is when patients need to refill the prescription or ask you about whether they need another prescription for SPIOLTO® RESPIMAT®. Once the dose indicator has reached the end of the scale, all puffs have been used and RESPIMAT® locks automatically. At this point, the clear base of the inhaler cannot be turned.1

Why are two puffs needed for once daily SPIOLTO® RESPIMAT®?

In general, the dose of medication delivered by RESPIMAT® is precise and consistent. Since dosing is more precise when administered as two actuations versus one actuation for a product used once daily, it was Boehringer Ingelheim’s decision to use two actuations per dose for SPIOLTO® RESPIMAT®. This is in agreement with all worldwide approvals and was accepted by all Health Authorities. (Administering the recommended medicinal dose as two actuations is not unusual for other inhalative products including pressurized metered dose inhalers (pMDIs)).

Can patients take one puff of SPIOLTO® RESPIMAT®?

No, SPIOLTO® RESPIMAT® will accurately deliver the consistent and appropriate dose when two actuations are administered once-daily.1

Can the dose be split into one puff each in the morning and evening?

According to the SPIOLTO® RESPIMAT® SmPC, the recommended dose is 5 μg tiotropium and 5 μg olodaterol given as two puffs once daily from RESPIMAT®, in accordance with the dosing used in clinical trials. The dose of two puffs once daily should not be split into one puff in the morning and one puff in the evening. Due to the 24-hour duration of action of SPIOLTO® RESPIMAT®, patients are fully covered throughout the entire day and night with once-daily dosing.1,2

Should SPIOLTO® RESPIMAT® be taken in the morning or the evening?

SPIOLTO® RESPIMAT® is a once-daily treatment with 24-hour duration of action. SPIOLTO® RESPIMAT® should be administered once a day, around the same time every day. The Summary of Product Characteristics (SmPC) does not specify the time of day. In clinical trials, SPIOLTO® RESPIMAT® was administered in the morning.1

Why is lung deposition important?

The success of inhaled respiratory therapies depends on the efficient delivery of the medication to the lungs via the inhaler. Only medication particles that reach the lungs and stay there can provide therapeutic effects. The therapeutic effect of an inhaled therapy depends on the dose deposited as well as its distribution in the lungs.3

Does the patient need to breathe differently when using SPIOLTO® RESPIMAT®?

Patients need to breathe out slowly and fully, then close their lips around the mouthpiece. While taking in a slow deep breath, they need to press the dose release button and keep breathing in slowly.1

How long can the patient keep SPIOLTO® RESPIMAT® after the inhaler has been opened?

SPIOLTO® RESPIMAT® should be discarded three months after patients have prepared it for first use, even if it has not been fully used or used at all.1

How should patients dispose of SPIOLTO® RESPIMAT®?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.1

SPIOLTO® RESPIMAT® and special populations

Is SPIOLTO® RESPIMAT® suitable for use in renally impaired patients?

Renally impaired patients can use  SPIOLTO® RESPIMAT® at the recommended dose.1

SPIOLTO® RESPIMAT® contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.1

As plasma concentration of tiotropium increases with decreased renal function in patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min) SPIOLTO® RESPIMAT® should be used only if the expected benefit outweighs the potential risk. There is no long term experience in patients with severe renal impairment.1

There is limited experience with the use of olodaterol in patients with severe renal impairment.1

Is SPIOLTO® RESPIMAT® suitable for use in hepatically impaired patients?

Patients with mild and moderate hepatic impairment can use SPIOLTO® RESPIMAT® at the recommended dose.1

There are no data available for use of olodaterol in patients with severe hepatic impairment.1

SPIOLTO® RESPIMAT® contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.1

Is SPIOLTO® RESPIMAT® suitable for use in geriatric patients?

Elderly patients can use SPIOLTO® RESPIMAT® at the recommended dose.1

Is SPIOLTO® RESPIMAT® suitable for use in pregnant and breast-feeding women?

There is no or very limited amount of data from the use of tiotropium and olodaterol in pregnant women. As a precautionary measure, it is preferable to avoid the use of SPIOLTO® RESPIMAT® during pregnancy.1

Like other beta2-adrenergic agonists, olodaterol a component of SPIOLTO® RESPIMAT® may inhibit labour due to a relaxant effect on uterine smooth muscle.1

Clinical data from nursing women exposed to tiotropium and/or olodaterol are not available.1

In animal studies for both tiotropium and olodaterol the substances and/or their metabolites have been detected in the milk of lactating rats, but it is not known whether tiotropium and/or olodaterol passes into human breast milk.1

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with SPIOLTO® RESPIMAT® should be made taking into account the benefit of breast-feeding to the child and the benefit of SPIOLTO® RESPIMAT® therapy to the woman.1

Is SPIOLTO® RESPIMAT® suitable for use in COPD patients with cardiovascular comorbidities?

SPIOLTO® RESPIMAT® is not contraindicated in patients with cardiovascular disease however any LABA-containing treatment should be used with caution in patients with cardiovascular disease, especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension, and aneurysm, in patients with convulsive disorders or thyrotoxicosis, in patients with known or suspected prolongation of the QT interval (e.g. QT> 0.44 s), and in patients who are unusually responsive to sympathomimetic amines.1,4

Data from the TONADO pivotal trials taken together with data from the wider Phase III clinical programme, provide evidence for the long-term safety and tolerability of once-daily tiotropium/olodaterol 5/5 mg. There was no evidence of increased cardiovascular risk with tiotropium/olodaterol 5/5 mg in comparison to its monocomponents.4,5

Is SPIOLTO® RESPIMAT® indicated for asthma?

No,  SPIOLTO® RESPIMAT® is not indicated for the treatment of asthma. SPIOLTO® RESPIMAT® is indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.1

Can SPIOLTO® RESPIMAT® be prescribed for patients who have both asthma and COPD?

SPIOLTO® RESPIMAT® is not approved for the treatment of asthma. If you diagnose both COPD and asthma in one patient, asthma guidelines recommend to treat the asthma component with an ICS.6

SPIOLTO® RESPIMAT® is only indicated for the treatment of COPD. It can be used to treat the COPD component in these patients. SPIOLTO® RESPIMAT® can help them maximise their lung function from the start of maintenance therapy.1,7

SPIOLTO® RESPIMAT® – evidence from clinical trials

How does SPIOLTO® RESPIMAT® work (Mode of Action)?

SPIOLTO® RESPIMAT® combines a long-acting anticholinergic (tiotropium) with a long-acting beta2‑agonist (olodaterol).1

Tiotropium and olodaterol in combination provide additive bronchodilation due to their different mode of action and different locations of the target receptors in the lungs.1

SPIOLTO® RESPIMAT® provides sustained 24-hour maintenance treatment for COPD.1

How quickly is the onset of action of SPIOLTO® RESPIMAT®?

SPIOLTO® RESPIMAT® starts working within 5 minutes of the first dose and provides efficacy over 24 hours.1,2,8

What is the SPIOLTO® RESPIMAT® clinical trial programme?

TOviTO® is the >16,000 patient Phase III clinical trial programme investigating the efficacy and safety of SPIOLTO® RESPIMAT® in COPD.2,5,7, 9-15

TOviTO® evaluates the effect of SPIOLTO® RESPIMAT® on lung function, quality of life, exacerbations, exercise tolerance and other important clinical outcomes related to the daily life of patients with COPD.2,5,7, 9-15

 

What were the most common SPIOLTO® RESPIMAT® adverse events?

SPIOLTO® RESPIMAT®, tiotropium/olodaterol in combination, has a comparable adverse event (AE) profile to the component monotherapies.1,2,5 The rate of discontinuation due to AEs with SPIOLTO® RESPIMAT® was comparable to that of SPIRIVA®.2,5 The most common AEs with SPIOLTO® RESPIMAT® (>3% incidence and higher than any of the monotherapies- tiotropium and/or olodaterol) in the pivotal TONADO® trials were nasopharyngitis, cough and back pain.For more information see the SmPC.

Are there certain patient groups who respond better to SPIOLTO® RESPIMAT®?

SPIOLTO® RESPIMAT® is indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.1

All COPD patients qualifying for maintenance treatment can receive benefits from using SPIOLTO® RESPIMAT®. Consistent superiority has been demonstrated for SPIOLTO® RESPIMAT® over its monocomponents and placebo.5,7,14

In addition, the greatest improvements in lung function and quality of life compared with SPIRIVA® have been seen in maintenance-naïve patients*, including patients with GOLD 2 airflow limitation.7 Improvements in quality of life vs SPIRIVA® are most apparent in GOLD B patients (i.e, in those patients with higher symptom load and none or only one moderate exacerbation in the previous year).11

*prior LAMA or LABA maintenance therapy

What is the difference between SPIOLTO® RESPIMAT® and SPIRIVA® in COPD?

SPIOLTO® RESPIMAT® contains tiotropium, the active ingredient in SPIRIVA®, plus the beta2-agonist olodaterol. SPIOLTO® RESPIMAT® offers consistent benefits beyond SPIRIVA® in lung function, quality of life, breathlessness and a trend towards reducing the risk of exacerbations.5,14 The safety profile of SPIOLTO® RESPIMAT® is comparable to that of SPIRIVA® and STRIVERDI®.1,5,16 For details regarding efficacy differences please see the SPIOLTO® RESPIMAT® efficacy section.

How does SPIOLTO® RESPIMAT® compare with SPIRIVA® with respect to COPD exacerbations?

SPIOLTO® RESPIMAT® contains tiotropium, the active ingredient in SPIRIVA®.1 SPIRIVA® is unsurpassed in reducing the risk of moderate-to-severe exacerbations vs mono- and dual-combination therapies.17-21

The TONADO trials showed an initial signal that SPIOLTO® RESPIMAT® reduced the number of moderate to severe exacerbations beyond SPIRIVA® but the TONADO trials were not powered for exacerbations.5

* SPIRIVA® RESPIMAT® and SPIRIVA® HandiHaler® showed comparable exacerbation efficacy.21
† Exacerbations were considered as severe if admission to hospital was needed. Data presented refer to treatment with once-daily SPIRIVA® 18 μg via HandiHaler®.17-21

How does SPIOLTO® RESPIMAT® compare with a LABA/ICS?

In contrast to a LABA/ICS, a LAMA/LABA (such as SPIOLTO® RESPIMAT®) is a recommended option in the GOLD 2017 Strategy Report for treatment initiation in a majority of symptomatic COPD patients.22

In the ENERGITO® trial, SPIOLTO® RESPIMAT® provided significantly greater lung function improvement compared with a LABA/ICS. Specifically, once-daily SPIOLTO® RESPIMAT® demonstrated a 69% improvement in FEV1 AUC0-12 over twice-daily fluticasone/salmeterol 50/500 µg (Seretide®).13

What is the effect on the reduction of COPD symptoms with SPIOLTO® RESPIMAT®?

Compared to SPIRIVA®, SPIOLTO® RESPIMAT® has demonstrated up to 52% improvement in breathlessness and a reduction in hyperinflation.2,13 In another trial SPIOLTO® RESPIMAT® has demonstrated clinically meaningful improvements in SGRQ scores (a measure of quality of life in COPD patients) versus placebo.12,14

References

  1. SPIOLTO® RESPIMAT® Summary of Product Characteristics.
  2. Beeh K-M, et al. Pulm Pharmacol Ther 2015; 32:53-59.
  3. Dalby R, et al. Int J Pharm. 2004;283:1-9.
  4. Buhl R et al Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe COPD Resp Med 2017; 122: 58-66
  5. Buhl R, et al. Eur Respir J 2015;45:969-979 and supplementary information.
  6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Available at: www.ginasthma.org. [Accessed July 2017].
  7. Ferguson GT, et al. Adv Ther 2015; 32:523-536.
  8. Ferguson GT, et al. Poster PA2957 presented at European Respiratory Society International Congress, Amsterdam, The Netherlands, 26–30 September 2015.
  9. O’Donnell DE, et al. Eur Respir J 2017;49:(4).Pii:4601348.
  10. Troosters T, et al. BMJ Open 2016;6(4):e010106. doi: 10.1136/bmjopen-2015-010106.
  11. Bourbeau J, et al. BMJ Open 2016;6(4):e010109. doi: 10.1136/bmjopen-2015-010109.
  12. Singh D, et al. Respiratory Research 2016; 17:73.
  13. Beeh K-M, et al. Int J COPD 2016;11:193-205.
  14. Singh D, et al. Resp Med 2015;109(10):1312-19 and supplementary information.
  15. Maltais F, et al. Thorax 2014; 69: A186-A187.
  16. SPIRIVA® RESPIMAT® Summary of Product Characteristics.
  17. Wedzicha JA, et al. Lancet Respir Med. 2013;1:199-209.
  18. Decramer M, et al. Lancet Respir Med. 2014;2:472-486.
  19. Wedzicha JA, et al; for the INSPIRE Investigators. Am J Respir Crit Care Med. 2008;177(1):19-26.
  20. Vogelmeier C, et al; for the POET-COPD Investigators. N Engl J Med. 2011;364(22):1093-1103.
  21. Decramer ML, et al. Lancet Respir Med. 2013;1(7):524-53.
  22. Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Available at: http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. [Accessed August 2017].