Stiolto
For Healthcare Professionals
skip to main
GOLD 2024 Report Banner

With a focus on symptoms, 
landmark changes put 
LAMA/LABA at the forefront of 
first-line therapy1

LAMA/LABA is preferred initial therapy for the majority of patients regardless of exacerbation risk2,3

LAMA/LABA is the preferred initial pharmacological treatment for the majority of patients with COPD
  • *
    Single inhaler therapy may be more convenient and effective than multiple inhalers; single inhalers improve adherence to treatment. 
    Exacerbations refers to the number of exacerbations per year; eos: blood eosinophil count in cells per microliter; mMRC: modified Medical Research Council dyspnea questionnaire; CATTM: COPD Assessment TestTM.

Adapted from © 2023, 2024 Global Initiative for Chronic Obstructive Lung Disease, Inc. Available from www.goldcopd.org; published in Deer Park, IL, USA.

Quick links

The use of LABA + ICS is no longer encouraged
for the treatment of COPD1,4

Approximately 80% of COPD patients should begin treatment with a LAMA/LABA
  • †
    The International Journal of Chronic Obstructive Pulmonary Disease study assessed the proportion of patients with COPD who may benefit the most from ICS-based therapy in a real-world population of 1528 patients.2
  • ‡
    The EClinicalMedicine study assessed the distribution of COPD patients initiating maintenance therapy and established patients by GOLD group, as well as the prevalence of comorbidities and appropriateness of therapy, in 12,108 patients.3

Learn more about using LAMA/LABA in COPD from the Chair of the GOLD Science Committee

Review the 2024 GOLD report.

LAMA, long-acting antimuscarinic agent; LABA, long-acting beta2-agonist; GOLD, Global Initiative for Chronic Obstructive Lung Disease; ICS, inhaled corticosteroid.

INDICATION for STIOLTO RESPIMAT

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 

Important Limitations of Use

STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION for STIOLTO RESPIMAT

CONTRAINDICATION

Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid (ICS) is contraindicated in patients with asthma.

STIOLTO is contraindicated in patients with hypersensitivity to tiotropium, ipratropium (atropine derivatives), olodaterol, or any component of this product.

In clinical trials and postmarketing experience with tiotropium, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported. Hypersensitivity reactions were also reported in clinical trials with STIOLTO.

 

WARNINGS AND PRECAUTIONS

LABA as monotherapy (without an ICS), for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, increases the risk of asthma-related hospitalizations.

Do not initiate STIOLTO in patients with acutely deteriorating COPD, which may be a life-threatening condition, or used as rescue therapy for acute symptoms. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.

STIOLTO should not be used more often or at higher doses than recommended, or with other LABAs as an overdose may result.

If immediate hypersensitivity reactions occur, such as urticaria, angioedema, rash, bronchospasm, anaphylaxis, or itching, discontinue STIOLTO at once and consider alternative treatment. Patients with a history of hypersensitivity reactions to atropine or its derivatives should be closely monitored for similar hypersensitivity reactions to STIOLTO.

If paradoxical bronchospasm occurs, discontinue STIOLTO immediately and institute alternative therapy.

STIOLTO can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, and/or symptoms. If such effects occur, STIOLTO may need to be discontinued.

Use caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a physician immediately if signs or symptoms of acute narrow-angle glaucoma develop.

Use with caution in patients with urinary retention especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a physician immediately should any of these signs or symptoms develop.

Patients with moderate to severe renal impairment (creatinine clearance of <60 mL/min) should be monitored closely for anticholinergic side effects.

Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

The most common adverse reactions with STIOLTO (>3% incidence and higher than an active control) were: nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back pain, 3.6% (1.8%/3.4%).

DRUG INTERACTIONS

  • Use caution if administering adrenergic drugs because sympathetic effects of olodaterol may be potentiated.

  • Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of olodaterol.

  • Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.

  • The action of adrenergic agents on the cardiovascular system may be potentiated by monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval. Therefore, STIOLTO should be used with extreme caution in patients being treated with these drugs. Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.

  • Avoid co-administration of STIOLTO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.  
     

STIOLTO is for oral inhalation only.

The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Inform patients not to spray STIOLTO into the eyes as this may cause blurring of vision and pupil dilation.

CL-STO-100021 6.5.2019

Please see full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

REFERENCES

  1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [2024 report]. Accessed November 20, 2023.
    https://goldcopd.org/wp-content/uploads/2023/11/GOLD-2024_v1.0-30Oct23_WMV.pdf

  2. Vestbo J, Vogelmeier CF, Small M, Siddall J, Fogel R, Kostikas K. Inhaled corticosteroid use by exacerbations and eosinophils: a real-world COPD population. Int J Chron Obstruct Pulmon Dis. 2019;14:853-861.

  3. Halpin DMG, de Jong HJI, Carter V, Skinner D, Price D. Distribution, temporal stability and appropriateness of therapy of patients with COPD in the UK in relation to GOLD 2019. EClinicalMedicine. 2019;14:32-41.

  4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [2022 report]. Accessed September 28, 2023.
    https://goldcopd.org/wp-content/uploads/ 2021/12/GOLD-REPORT-2022-v1.1-22Nov2021_WMV.pdf