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STIOLTO® RESPIMAT® (TIOTROPIUM BROMIDE & OLODATEROL) INHALATION SPRAY

 * Home
 * Inhaleability
 * Symptom Control
 * Efficacy
 * Safety Profile
 * How to Use
 * Savings & Support




PATIENTS WITH COPD STRUGGLE TO INHALE BECAUSE THEY LIVE WITH DAMAGED LUNGS.[1]
WHY SHOULD THEY ALSO STRUGGLE TO INHALE THEIR MEDICINE?




START WITH INHALEABILITY, START WITH THE SOFT MIST OF STIOLTO RESPIMAT.[2]


Inhaleability
The soft mist of STIOLTO RESPIMAT gives your patients inhaleability.
Efficacy
STIOLTO RESPIMAT has been studied in clinical trials including over 15,000
patients.[3]
Patient Support
Improved coverage for eligible patients—prescribe STIOLTO RESPIMAT with expanded
access.

QUICK LINKS

 * Quick Start Guide
 * RespiPoints™

Do not use more than 2 puffs every 24 hours.

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

 
REFERENCES

 1. 1.
    
    Loh CH, Peters SP, Lovings TM, Ohar JA. Suboptimal inspiratory flow rates
    are associated with chronic obstructive pulmonary disease and all-cause
    readmissions. Ann Am Thorac Soc. 2017;14(8):1305-1311.
    
     
 2. 2.
    
    STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer
    lngelheim Pharmaceuticals, Inc; August 2020.

 3. 3.
    
    Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

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