Olodaterol Hydrochloride

Name: Olodaterol Hydrochloride

Introduction

Bronchodilator; a relatively selective, long-acting β2-adrenergic agonist.1 2 3 4 5 7 11 12

Uses for Olodaterol Hydrochloride

Bronchospasm in COPD

Olodaterol alone or in fixed combination with tiotropium used for long-term maintenance treatment of airflow obstruction associated with COPD, including chronic bronchitis and emphysema.1 2 3 4 11 12 13

Not indicated for the treatment of acute bronchospasm (i.e., as rescue therapy for treatment of acute episodes of bronchospasm).1 12

Other Uses

Not indicated for treatment of asthma†; safety and efficacy in asthma not established.1 12

Cautions for Olodaterol Hydrochloride

Contraindications

  • All long-acting β2-adrenergic agonists, including olodaterol, contraindicated in patients with asthma without concomitant use of long-term asthma controller therapy; olodaterol not indicated for treatment of asthma.1 12 (See Asthma-related Death under Cautions.)

  • Known hypersensitivity to olodaterol or any ingredient in the formulation.12

Warnings/Precautions

Warnings

Use of Fixed Combinations

When used in fixed combination with tiotropium, consider the cautions, precautions, contraindications, and interactions associated with tiotropium.12

Asthma-related Death

Increased risk of asthma-related death reported with long-acting β2-adrenergic agonists (e.g., olodaterol).1 8 12 (See Boxed Warning.) Data from clinical trials also suggest that long-acting β2-adrenergic agonists increase the risk of asthma-related hospitalization in pediatric and adolescent patients.8 Safety and efficacy of olodaterol in patients with asthma† not established; drug not indicated for treatment of asthma.1 12

Large safety study (Salmeterol Multicenter Asthma Research Trial [SMART]) showed an increase in asthma-related deaths in patients receiving salmeterol.1 9 12 Increased risk of asthma-related death with salmeterol considered a class effect of long-acting β2-adrenergic agonists, including olodaterol.1 12 However, no adequate studies conducted to determine whether rate of asthma-related death is increased in patients receiving olodaterol.1 12

Not known whether death rate is increased in patients with COPD receiving long-acting β2-adrenergic agonists, including olodaterol.1 12

Other Warnings/Precautions

Deterioration of Disease and Acute Episodes

Do not initiate olodaterol in patients with acutely deteriorating COPD, which may be life-threatening.1 12

Do not use olodaterol for relief of acute symptoms.1 12 Not studied in patients with acute symptoms; do not use extra doses of the drug in such situations.1 12 Use a short-acting, inhaled β2-agonist as needed for acute symptoms.1 12

When initiating therapy, discontinue regular use (e.g., 4 times daily) of short-acting inhaled β2-agonists and use such agents only for relief of acute symptoms.1 12

Failure to respond to a previously effective dosage of olodaterol or to a supplemental short-acting, inhaled β2-agonist (e.g., increased need for additional short-acting, inhaled β2-agonists) may indicate substantially worsening COPD.1 12 Immediately reevaluate patient and treatment regimen.1 12 Do not use extra or increased dosages of olodaterol in such situations.1 12

Excessive Use and Use With Other Long-acting β2-Adrenergic Agonists

Possible fatalities and/or adverse cardiovascular effects reported in association with excessive use of inhaled sympathomimetic drugs.1 12

Do not use olodaterol more frequently or at dosages higher than recommended or concomitantly with other preparations containing long-acting β2-adrenergic agonists, since overdosage may result.1 12

Do not use olodaterol with another preparation containing a long-acting β2-agonist (e.g., arformoterol, formoterol, indacaterol, salmeterol, vilanterol) for any reason.1 12

Paradoxical Bronchospasm

Possible acute, life-threatening paradoxical bronchospasm.1 12 If paradoxical bronchospasm occurs, immediately discontinue therapy with olodaterol and institute alternative therapy.1 12

Cardiovascular Effects

Possible clinically important increases in pulse rate, systolic or diastolic BP, or symptoms of cardiovascular disease; may require discontinuance of drug.1 12

ECG changes (e.g., flattening of T wave, prolongation of corrected QT [QTc] interval, ST-segment depression) reported with β2-agonists; clinical importance unknown.1 12

Administration of larger than recommended dosages of orally inhaled olodaterol (10–50 mcg) in healthy individuals resulted in dose-related increases in QTc interval.1 12 Use with caution in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias, known prolongation of the QT interval, hypertrophic obstructive cardiomyopathy, hypertension).1 12

No clinically important effects on heart rate or premature beats reported in patients with COPD receiving olodaterol in clinical trials.1 12

Metabolic and Electrolyte Effects

Use with caution in patients with thyrotoxicosis.1 12

IV albuterol (IV preparation not commercially available in US) reported to aggravate preexisting diabetes mellitus and ketoacidosis.1 12 β2-Adrenergic agonists may cause hyperglycemia in some patients.1 12 Clinically important changes in serum glucose concentrations infrequent (incidence similar to placebo) in patients with COPD receiving long-term treatment with olodaterol in clinical trials.1 12

Clinically important hypokalemia (usually transient and not requiring supplementation) may occur in some patients receiving β2-adrenergic agonists; may result in adverse cardiovascular effects.1 12 (See Cardiovascular Effects under Cautions.) Hypokalemia may be potentiated by hypoxia or by concomitant treatment in patients with severe COPD; may result in increased susceptibility to arrhythmias.1 12

Clinically important changes in serum potassium concentrations infrequent (incidence similar to placebo) in patients with COPD receiving long-term treatment with olodaterol in clinical trials.1 12

Nervous System Effects

Use with caution in patients with seizure disorders and in those unusually responsive to sympathomimetic amines.1 12

Sensitivity Reactions

Immediate hypersensitivity reactions, including angioedema, reported.1 12 If a hypersensitivity reaction occurs, discontinue olodaterol immediately and consider alternative therapy.1 12

Specific Populations

Pregnancy

Category C.1 12

May interfere with uterine contractility.1 12 Carefully weigh benefit versus risk in labor.1 12

Lactation

Distributed into milk in rats.1 12 Not known whether distributed into human milk.1 12 Effects of maternal use of orally inhaled olodaterol on nursing infants not evaluated.1 12 Use caution.1 12

Pediatric Use

Not indicated for use in pediatric patients.1 12 Safety and efficacy not established.1 12

Geriatric Use

No overall differences in safety and efficacy observed between geriatric and younger adults.1 12 (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics of olodaterol not substantially altered in patients with mild or moderate hepatic impairment.1 12 Not evaluated in patients with severe hepatic impairment.1 12 Dosage adjustment not required in patients with mild or moderate hepatic impairment.1 12

Renal Impairment

Olodaterol concentrations increased in patients with severe renal impairment;1 12 increases not considered clinically important.1 Not evaluated in patients with mild or moderate renal impairment.1 12 Dosage adjustment not required.1 12

Monitor patients with moderate to severe renal impairment receiving olodaterol/tiotropium in fixed combination for anticholinergic effects.12

Common Adverse Effects

Nasopharyngitis,1 2 3 12 upper respiratory tract infection,1 2 3 bronchitis,1 2 3 cough,1 2 3 12 back pain,1 2 3 12 diarrhea,1 2 3 urinary tract infection,1 2 3 dizziness,1 2 3 rash,1 arthralgia.1 3

Advice to Patients

  • Provide copy of the manufacturer's patient information (medication guide) and instructions for use to all patients each time drug is dispensed.1 12 Importance of instructing patients to read the medication guide prior to initiation of therapy and each time prescription is refilled.1 12

  • Importance of informing patients that long-acting β2-adrenergic agonists (including olodaterol) increase the risk of asthma-related death and that olodaterol is not indicated for the treatment of asthma.1 8 12

  • Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the inhalation delivery system (Respimat).1 12

  • Importance of not using olodaterol to relieve acute COPD symptoms; do not use extra doses for such symptoms.1 12

  • Importance of advising patients that if a dose is missed, to take the dose as soon as it is remembered; importance of not taking more than one dose (2 inhalations) in a 24-hour period.1 12

  • Importance of all patients being provided with and instructed in the use of a short-acting, inhaled β2-agonist as treatment for acute COPD symptoms.1 12

  • Importance of discontinuing regular use of short-acting, inhaled β2-agonists when initiating olodaterol and using short-acting, inhaled β2-agonists to relieve acute symptoms.1 12

  • Importance of contacting a clinician immediately if symptoms worsen, the short-acting β2-agonist becomes less effective or more inhalations than usual are required to relieve symptoms, or clinically important decrease in lung function occurs.1 12

  • Importance of advising patients receiving olodaterol not to use other long-acting, inhaled β2-agonists.1 12

  • Importance of patients not discontinuing therapy without medical supervision, since symptoms may recur after discontinuance.1 12

  • Importance of informing patients of adverse effects associated with β2-agonists (e.g., palpitations, chest pain, tachycardia, tremor, nervousness).1 12

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 12

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., cardiac disease, hypertension, seizures, thyroid disease, diabetes mellitus, allergies to drugs or food).1 12

  • Importance of informing patients of other important precautionary information.1 12 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Olodaterol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Solution for inhalation

2.5 mcg (of olodaterol) per metered spray

Striverdi Respimat

Boehringer Ingelheim

Olodaterol Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Solution for inhalation

2.5 mcg (of olodaterol) with Tiotropium Bromide 2.5 mcg (of tiotropium) per metered spray

Stiolto Respimat

Boehringer Ingelheim

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