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 with STIOLTO.
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 respiratory symptoms.
STIOLTO should not be used more often or at higher doses than recommended, or in conjunction with other LABA as an overdose may result.
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 STIOLTO.
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%).
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.
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.
STIOLTO is NOT indicated to treat acute deterioration of COPD and is not indicated to treat asthma.