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