HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
STIOLTO RESPIMAT safely and effectively. See full prescribing
information for STIOLTO RESPIMAT.
STIOLTO
®
RESPIMAT
®
(tiotropium bromide and olodaterol inhalation
spray), for oral inhalation use
Initial U.S. Approval: 2015
----------------------------INDICATIONS AND USAGE---------------------------
STIOLTO RESPIMAT is a combination of tiotropium, an anticholinergic and
olodaterol, a long-acting beta
2
-adrenergic agonist (LABA) indicated for the
long-term, once-daily maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD). (1.1)
Important limitations:
• STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of
COPD. (1.1)
• STIOLTO RESPIMAT is NOT indicated to treat asthma. (1.1)
----------------------DOSAGE AND ADMINISTRATION-----------------------
• For oral inhalation only.
• Two inhalations of STIOLTO RESPIMAT once-daily at the same time
of day. (2)
---------------------DOSAGE FORMS AND STRENGTHS----------------------
Inhalation spray: Each actuation from the mouthpiece delivers 2.5 mcg
tiotropium (equivalent to 3.124 mcg tiotropium bromide monohydrate), and
2.5 mcg olodaterol (equivalent to 2.736 mcg olodaterol hydrochloride).
Two actuations equal one dose. (3)
-------------------------------CONTRAINDICATIONS------------------------------
• Use of a LABA, including STIOLTO RESPIMAT, without an inhaled
corticosteroid is contraindicated in patients with asthma. (4)
• Hypersensitivity to tiotropium, ipratropium, olodaterol, or any
component of this product. (4)
-----------------------WARNINGS AND PRECAUTIONS------------------------
• LABA as monotherapy (without an inhaled corticosteroid) for asthma
increases the risk of serious asthma-related events. (5.1)
• Do not initiate STIOLTO RESPIMAT in acutely deteriorating COPD
patients. (5.2)
• Do not use for relief of acute symptoms. Concomitant short-acting beta
2
-
agonists can be used as needed for acute relief. (5.2)
• Do not exceed the recommended dose. Excessive use of STIOLTO
RESPIMAT, or use in conjunction with other medications containing
LABA can result in clinically significant cardiovascular effects and may
be fatal. (5.3)
• Immediate hypersensitivity reactions: Discontinue STIOLTO
RESPIMAT at once and consider alternatives if immediate
hypersensitivity reactions, including angioedema, urticaria, rash,
bronchospasm, or anaphylaxis, occur. (5.4)
• Life-threatening paradoxical bronchospasm can occur. Discontinue
STIOLTO RESPIMAT immediately. (5.5)
• Use with caution in patients with cardiovascular or convulsive disorders,
thyrotoxicosis, or sensitivity to sympathomimetic drugs. (5.6, 5.7)
• Worsening of narrow-angle glaucoma may occur. Use with caution in
patients with narrow-angle glaucoma and instruct patients to consult a
physician immediately if this occurs. (5.8)
• Worsening of urinary retention may occur. Use with caution in patients
with prostatic hyperplasia or bladder-neck obstruction and instruct
patients to consult a physician immediately if this occurs. (5.9)
• Be alert to hypokalemia and hyperglycemia. (5.11)
------------------------------ADVERSE REACTIONS-------------------------------
The most common adverse reactions (>3% incidence and more than an active
control) were nasopharyngitis, cough, and back pain.
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer
Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
------------------------------DRUG INTERACTIONS-------------------------------
• Other adrenergic drugs may potentiate effect. Use with caution. (5.3,
7.1)
• Xanthine derivatives, steroids, diuretics, or non-potassium sparing
diuretics may potentiate hypokalemia or ECG changes. Use with
caution. (7.2, 7.3)
• MAO inhibitors, tricyclic antidepressants, and drugs that prolong QTc
interval may potentiate effect on cardiovascular system. Use with
extreme caution. (7.4)
• Beta-blockers may decrease effectiveness. Use with caution and only
when medically necessary. (7.5)
• Anticholinergics: May interact additively with concomitantly used
anticholinergic medications. Avoid administration of STIOLTO
RESPIMAT with other anticholinergic-containing drugs. (7.6)
-----------------------USE IN SPECIFIC POPULATIONS------------------------
Patients with moderate to severe renal impairment should be monitored
closely for potential anticholinergic side effects. (2, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling.
Revised: 11/2021
_______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Maintenance Treatment of COPD
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Asthma-Related Events – Hospitalizations, Intubations,
Death
5.2 Deterioration of Disease and Acute Episodes
5.3 Excessive Use of STIOLTO RESPIMAT and Use With Other
Long-Acting Beta
2
-Agonists
5.4 Immediate Hypersensitivity Reactions
5.5 Paradoxical Bronchospasm
5.6 Cardiovascular Effects
5.7 Coexisting Conditions
5.8 Worsening of Narrow-Angle Glaucoma
5.9 Worsening of Urinary Retention
5.10 Renal Impairment
5.11 Hypokalemia and Hyperglycemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience in Chronic Obstructive Pulmonary
Disease
7 DRUG INTERACTIONS
7.1 Adrenergic Drugs
7.2 Sympathomimetics, Xanthine Derivatives, Steroids, or Diuretics
7.3 Non-Potassium Sparing Diuretics
7.4 Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc
Prolonging Drugs
7.5 Beta-Blockers
7.6 Anticholinergics
7.7 Inhibitors of Cytochrome P450 and P-gp Efflux Transporter
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13
NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility