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Olodaterol: Drug information

Olodaterol: Drug information
(For additional information see "Olodaterol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Striverdi Respimat
Pharmacologic Category
  • Beta2 Agonist;
  • Beta2-Adrenergic Agonist, Long-Acting
Dosing: Adult
Chronic obstructive pulmonary disease, maintenance

Chronic obstructive pulmonary disease, maintenance:

Note: Depending on symptoms and exacerbation risk, may use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, Group B), use in combination with long-acting muscarinic antagonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).

Soft mist inhaler (2.5 mcg/actuation): Oral inhalation: 2 inhalations once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild to moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Respiratory: Nasopharyngitis (11%)

1% to 10%:

Dermatologic: Skin rash (2%)

Genitourinary: Urinary tract infection (3%)

Neuromuscular & skeletal: Back pain (4%), arthralgia (2%)

Respiratory: Bronchitis (5%)

<1%, postmarketing and/or case reports: Asthma-related death, constipation, cough, depression of ST segment on ECG, diarrhea, dizziness, fever, flattened T wave on ECG, hypersensitivity reaction (includes angioedema), hypokalemia (transient), increased serum glucose (high doses), increased diastolic blood pressure, increased pulse, increased systolic blood pressure, malignant neoplasm of lung, paradoxical bronchospasm, pneumonia, prolonged QT interval on ECG, rhinorrhea, upper respiratory tract infection

Contraindications

Monotherapy (without use of a concomitant inhaled corticosteroid) in the treatment of asthma

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to olodaterol or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Asthma-related deaths: Monotherapy with a long-acting beta-2 agonist (LABA) is contraindicated in the treatment of asthma. The use of LABAs as monotherapy has been associated with an increased risk of severe exacerbations and asthma-related deaths (SMART [Nelson 2006]; Walters 2007); additional data from other clinical trials suggest risk of asthma-related hospitalization may also be increased with LABA monotherapy in pediatric and adolescent patients. However, data from large, randomized, double-blind controlled trials do not show a significant increase in risk of serious asthma-related events (including hospitalizations, intubations, and death) in adults, adolescents, and pediatric patients (4 to 11 years of age) when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy (FDA 2017). Olodaterol is not indicated for the treatment of asthma.

• Bronchospasm: Paradoxical bronchospasm that may be life-threatening may occur with use of inhaled beta-2 agonists; this reaction should be distinguished from inadequate response. Discontinue medication immediately if paradoxical bronchospasm occurs and institute alternative therapy.

• Hypersensitivity: Immediate hypersensitivity reactions, including angioedema, may occur; discontinue therapy if patient develops an allergic reaction.

• Serious effects/fatalities: Do not exceed recommended dose or frequency or use with other medications containing LABAs; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia, coronary insufficiency, hypertension, or hypertrophic obstructive cardiomyopathy); beta-agonists may cause elevation in blood pressure and heart rate. Beta-2 agonists may also produce electrocardiogram (ECG) changes (eg, T-wave flattening, QTc prolongation, ST segment depression).

• COPD: Appropriate use: Do not use for acute bronchospastic episodes of COPD. Do not initiate in patients with significantly worsening or acutely deteriorating COPD. Available data do not suggest an increased risk of death with use of a LABA in patients with COPD.

• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism; may stimulate thyroid activity.

• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium (transient).

• Seizures: Use with caution in patients with seizure disorders; beta-2 agonists may result in CNS stimulation/excitation.

Special populations:

• Pediatric: LABAs, when used as monotherapy, may increase the risk of asthma-related hospitalization in pediatric and adolescent patients. When LABAs are used in a fixed-dose combination with inhaled corticosteroids, data from large clinical trials in adolescents do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared to inhaled corticosteroids alone.

Other warnings/precautions:

• Patient information: Patients using inhaled, short-acting beta-2 agonists should be instructed to discontinue routine use of these medications prior to beginning treatment. Short-acting agents should still be provided to patients; however, use should be reserved for symptomatic relief of acute symptoms. Patients must be instructed to seek medical attention in cases in which acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of short-acting beta-2 agonists may indicate deterioration of COPD, and medical evaluation must not be delayed.

Dosage Forms Considerations

Striverdi Respimat 4 g delivers 60 inhalations (institutional pack delivers 28 inhalations).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Solution, Inhalation:

Striverdi Respimat: 2.5 mcg/actuation (4 g) [contains benzalkonium chloride, edetate (edta) disodium]

Generic Equivalent Available: US

No

Pricing: US

Aerosol solution (Striverdi Respimat Inhalation)

2.5 mcg/ACT (per gram): $78.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral inhalation: Soft mist inhaler: For oral inhalation only; administer at the same time each day. Prime inhaler prior to initial use or if not used for >21 days by pointing inhaler towards ground and actuating until aerosol cloud is seen, then repeat 3 additional times before use. If not used for >3 days (but ≤21 days), actuate once before use. To prepare inhaler for use after priming, refer to manufacturer labeling. When dose is ready to be administered, breathe in slowly through the mouth and press the dose release button; continue to breathe in slowly as long as possible, then hold breath for 10 seconds or for as long as comfortable. Repeat for second inhalation.

Use: Labeled Indications

Chronic obstructive pulmonary disease, maintenance: Long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema

Metabolism/Transport Effects

Substrate of CYP2C8 (minor), CYP2C9 (minor), CYP3A4 (minor), UGT1A1, UGT1A7, UGT1A9, UGT2B7; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Risk C: Monitor therapy

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Risk X: Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination

Caffeine and Caffeine Containing Products: May enhance the adverse/toxic effect of Olodaterol. Caffeine and Caffeine Containing Products may enhance the hypokalemic effect of Olodaterol. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta2 agonists for 36 hours before methacholine use. Risk D: Consider therapy modification

Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Theophylline Derivatives: Beta2-Agonists may enhance the adverse/toxic effect of Theophylline Derivatives. Specifically, sympathomimetic effects may be increased. Theophylline Derivatives may enhance the hypokalemic effect of Beta2-Agonists. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Beta-agonists have the potential to affect uterine contractility if administered during labor.

Breastfeeding Considerations

It is not known if olodaterol is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

FEV1, FVC, and/or other pulmonary function tests; serum potassium, serum glucose; blood pressure, heart rate; CNS stimulation. Monitor for increased use of short-acting beta2-agonist inhalers; may be marker of a deteriorating condition.

Mechanism of Action

Long acting beta2-receptor agonist; activates beta2 airway receptors, resulting in the stimulation of intracellular adenyl cyclase and a subsequent increase in the synthesis of cyclic-3’,5’ adenosine monophosphate (cAMP). Elevated cAMP levels induce bronchodilation by relaxation of airway smooth muscle cells. Has much greater affinity for beta2-receptors than for beta1- or beta3-receptors.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 5 minutes

Duration: 24 hours

Distribution: Vd: 1110 L

Protein binding: ~60%

Metabolism: Direct glucuronidation (UGT2B7, UGT1A1, 1A7, and 1A9) and O-demethylation (primarily CYP2C9 and 2C8)

Bioavailability: 30% (inhalation)

Half-life elimination: 7.5 hours

Time to peak: 10 to 20 minutes

Excretion: Urine (5% to 7% unchanged); feces

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Striverdi respimat;
  • (AT) Austria: Striverdi respimat;
  • (BE) Belgium: Striverdi respimat;
  • (BG) Bulgaria: Striverdi respimat;
  • (BR) Brazil: Striverdi respimat;
  • (CH) Switzerland: Striverdi respimat;
  • (CL) Chile: Striverdi respimat;
  • (CO) Colombia: Striverdi respimat;
  • (CZ) Czech Republic: Striverdi respimat;
  • (DE) Germany: Striverdi | Striverdi respimat;
  • (EC) Ecuador: Striverdi respimat;
  • (ES) Spain: Striverdi;
  • (FI) Finland: Striverdi respimat;
  • (FR) France: Striverdi respimat;
  • (GB) United Kingdom: Striverdi respimat;
  • (GR) Greece: Striverdi respimat;
  • (HK) Hong Kong: Striverdi respimat;
  • (HU) Hungary: Striverdi respimat;
  • (ID) Indonesia: Striverdi respimat;
  • (IE) Ireland: Striverdi respimat;
  • (IT) Italy: Striverdi respimat;
  • (LB) Lebanon: Striverdi respimat;
  • (LT) Lithuania: Striverdi respimat;
  • (LU) Luxembourg: Striverdi respimat;
  • (LV) Latvia: Striverdi respimat;
  • (MX) Mexico: Striverdi respimat;
  • (MY) Malaysia: Striverdi respimat;
  • (NL) Netherlands: Striverdi respimat;
  • (NO) Norway: Striverdi;
  • (PE) Peru: Striverdi respimat;
  • (PH) Philippines: Striverdi respimat;
  • (PL) Poland: Striverdi respimat;
  • (PT) Portugal: Striverdi respimat;
  • (RU) Russian Federation: Infortispir respimat | Striverdi respimat;
  • (SE) Sweden: Striverdi respimat;
  • (SG) Singapore: Striverdi respimat;
  • (SK) Slovakia: Striverdi respimat;
  • (TW) Taiwan: Striverdi respimat
  1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/gina-reports/. Updated 2022. Accessed September 23, 2022.
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for prevention, diagnosis and management of COPD: 2023 report. https://goldcopd.org/2023-gold-report-2/. Updated 2023. Accessed January 30, 2023.
  3. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26. [PubMed 16424409]
  4. Striverdi Respimat (olodaterol) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc; November 2021.
  5. Striverdi Respimat (olodaterol) [product monograph]. Burlington, Ontario, Canada: Boehringer Ingelheim (Canada) Ltd; May 2019.
  6. US Department of Health and Human Services; National Institutes of Health; National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007. http://www.nhlbi.nih.gov/files/docs/guidelines/asthgdln.pdf. Published August 28, 2007.
  7. US Food and Drug Administration. FDA drug safety communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-review-finds-no-significant-increase-risk-serious-asthma-outcomes. Published December 2017.
  8. Walters EH, Gibson PG, Lasserson TJ, Walters JA. Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroid. Cochrane Database Syst Rev. 2007;(1):CD001385. doi:10.1002/14651858.CD001385.pub2 [PubMed 17253458]
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