IMPORTANT SAFETY INFORMATION and INDICATION for STIOLTO RESPIMAT
WARNING: ASTHMA‑RELATED DEATH
Long‑acting beta2‑adrenergic agonists (LABA) such as olodaterol, one
of the active ingredients in STIOLTO RESPIMAT, increase the risk of
asthma‑related death. Data from a large, placebo‑controlled US study
that compared the safety of another long‑acting beta2‑adrenergic
agonist (salmeterol) with placebo added to usual asthma therapy
showed an increase in asthma‑related deaths in patients receiving
salmeterol. This finding with salmeterol is considered a class
effect of all LABA, including olodaterol, one of the active
ingredients in STIOLTO RESPIMAT. The safety and efficacy of STIOLTO
RESPIMAT in patients with asthma have not been established. STIOLTO
RESPIMAT is not indicated for the treatment of asthma.
All LABA are contraindicated in patients with asthma without use of a
long‑term asthma control medication. 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
WARNINGS AND PRECAUTIONS
STIOLTO should not be initiated 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. Patients who have been taking
inhaled, short‑acting beta2‑agonists on a regular basis should
discontinue the regular use of these drugs and use them only for acute
STIOLTO should not be used more often or at higher doses than
recommended, or in conjunction with other LABA as an overdose may
Immediate hypersensitivity reactions, including urticaria, angioedema,
rash, bronchospasm, anaphylaxis, or itching may occur after
administration of STIOLTO. If such a reaction occurs, discontinue
therapy with STIOLTO and consider alternative treatments. Patients with
a history of hypersensitivity reactions to atropine or its derivatives
should be closely monitored for similar hypersensitivity reactions to
If paradoxical bronchospasm occurs, STIOLTO should be discontinued immediately.
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 (e.g., eye pain or discomfort,
blurred vision, visual halos or colored images in association with red
eyes from conjunctival congestion and corneal edema).
Use with caution in patients with urinary retention, which can be
associated with symptoms like difficulty passing urine and painful
urination 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) treated with STIOLTO should be monitored closely for
anticholinergic side effects.
Be alert to hypokalemia, which has the potential to produce adverse
cardiovascular effects. Be alert to hyperglycemia.
The most common adverse reactions with STIOLTO (>3% incidence and
higher than any of the comparators — tiotropium and/or olodaterol) were:
nasopharyngitis, 12.4% (11.7%/12.6%), cough, 3.9% (4.4%/3.0%), and back
pain, 3.6% (1.8%/3.4%).
- 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.
- Beta agonists, such as olodaterol, can acutely worsen the ECG
changes and/or hypokalemia that may result from administration of
non‑potassium sparing diuretics. 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 beta‑agonists should be used
with extreme caution in patients being treated with these drugs.
Drugs that prolong the QTc interval may be associated with an
increased risk of ventricular arrhythmias.
Beta‑blockers should be used with caution as they can inhibit the
therapeutic effect of beta agonists which may produce severe
bronchospasms in patients with COPD. However, under certain
circumstances, e.g. as prophylaxis after myocardial infarction,
there may be no acceptable alternatives to the use of beta‑blockers
in patients with COPD. In this setting, cardio selective
beta‑blockers could be considered, although they should be
administered with caution.
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.
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 airflow obstruction in
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.
Please see full Prescribing
Information, including boxed WARNING,
Guide, and Instructions for Use.
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