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.
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%).
- 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
- 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.
Please see accompanying full
Patient Information, and
Instructions for Use for STIOLTO RESPIMAT.
References: 1. STIOLTO RESPIMAT [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2018.
2. Bateman ED, Tashkin D, Siafakas N, et al. A one-year trial of tiotropium Respimat® plus usual therapy in COPD patients. Respir Med. 2010;104(10):1460-1472.
3. Calverley P, Anzueto A, Carter K, et al. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active controlled trial. Lancet Respir Med. 2018;6(5):337-344.