olodaterol

olodaterol

(oh-loh-dat-er-ole),

Striverdi

(trade name)

Classification

Therapeutic: bronchodilators
Pharmacologic: beta adrenergic agonists
Pregnancy Category: C

Indications

Maintenance treatment of airflow obstruction in patients with COPD including chronic bronchitis and emphysema.

Action

A long-acting beta2-adrenergic agonist (LABA) that stimulates adenyl cyclase, resulting in accumulation of cyclic adenosine monophosphate (cAMP) at beta2-adrenergic receptors resulting in bronchodilation.

Therapeutic effects

Bronchodilation with decreased airflow obstruction.

Pharmacokinetics

Absorption: 30% absorbed following oral inhalation (from lung surface); swallowed drug is minimally absorbed.
Distribution: Extensive tissue distribution; probably enters breast milk.
Metabolism and Excretion: Extensively metabolized (some by CYP 3A4), only one metabolite binds to B2adrenergic receptors. Following inhalation, 5–7% excreted unchanged in urine, remainder in feces as drug and metabolites (84%).
Half-life: 45 hr (following inhalation).

Time/action profile (improvement in FEV1)

ROUTEONSETPEAKDURATION
inhalnwithin 1 hr1–5 hr24 hr

Contraindications/Precautions

Contraindicated in: Severe/acute/deteriorating symptoms of airflow obstruction.
Use Cautiously in: History of seizures; Thyrotoxicosis; History of cardiovascular disorders (coronary insufficiency, arrhythmias, hypertension); Sensitivity to sympathomimetics (adrenergics); Severe hepatic impairment; Obstetric: Use during pregnancy only if potential benefit justifies potential risk to the fetus; Lactation: Use cautiously if breastfeeding (probably enters breast milk); Pediatric: Safe and effective use in children has not been established.
Exercise Extreme Caution in: Concurrent use with MAOIs, tricyclic antidepressants or drugs that prolong QTc (↑ risk of adverse cardiovascular reactions).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Ear, Eye, Nose, Throat

  • nasopharyngitis (most frequent)

Respiratory

  • paradoxical bronchospasm (life-threatening)
  • cough

Cardiovascular

  • ↑ BP
  • ECG changes
  • tachycardia

Gastrointestinal

  • diarrhea

Endocrinologic

  • hyperglycemia

Fluid and Electrolyte

  • hypokalemia

Musculoskeletal

  • arthralgia
  • back pain

Miscellaneous

  • hypersensitivity reactions including angioedema (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use with MAOIs, tricyclic antidepressants, or drugs that prolong QTc ↑ risk of adverse cardiovascular reactions (use with extreme caution). Concurrent use of other adrenergics ↑ risk of adverse adrenergic adverse reactions (tachycardia, ↑ blood pressure). Concurrent use with corticosteroids, non-potassium sparing diuretics, or xanthine derivatives (including theophylline) may ↑ risk of hypokalemia and adverse cardiovascular reactions (use cautiously). Concurrent use with beta blockers may ↓ effectiveness and cause severe bronchospasm (use cautiously). Should not be used concurrently with any other long-acting beta2-adrenergic blockers (LABAs)Blood levels may be ↑ by ketoconazole.

Route/Dosage

Inhalation (Adults) 2 inhalations once daily.

Availability

Inhalation spray: 2.7 mcg (delivers 2.5 mcg) per actuation in cartridges containing 14 doses/cartridge (one actuation lost in priming) for use with Respimat inhaler

Nursing implications

Nursing assessment

  • Assess respiratory status (rate, breath sounds, degree of dyspnea, pulse) before administration and at peak of medication. Consult health care professional about alternative medication if severe bronchospasm is present; onset of action is too slow for patients in acute distress. If paradoxical bronchospasm (wheezing) occurs, withhold medication and notify health care professional immediately.
  • Monitor for signs and symptoms of allergic reactions (difficulties in breathing or swallowing, swelling of tongue, lips and face, urticaria, skin rash). Discontinue therapy if symptoms occur.
  • Lab Test Considerations: May cause transient hypokalemia and hyperglycemia.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)

Implementation

  • Inhalation: Prior to first use, prime the inhaler by actuating toward ground until aerosol cloud is visible, then repeat procedure 3 more times. If not used for 3 days, actuate inhaler once to prepare for use. Striverdi Respimat has a slow-moving mist to assist with inhalation. Use once (2 puffs), at the same time daily.
    • A rescue inhaler of short-acting beta2-agonists should always be available to treat sudden bronchospasm.

Patient/Family Teaching

  • Instruct patient in the correct use of Striverdi Respimat. Take missed doses as soon as remembered. Do not take more than 1 dose (2 puffs) in 24 hr. Advise patient not to discontinue without consulting health care professional; symptoms may recur.
  • Inform patient that olodaterol is not an rapid-actinga long-acting bronchodilator and should not be used for treating sudden breathing problems.
  • Advise patient to notify health care professional if signs and symptoms of allergic reaction, worsening symptoms; decreasing effectiveness of inhaled, short-acting beta2–agonists; need for more inhalations than usual of inhaled, short-acting beta2-agonists; or significant decrease in lung function occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products without consulting health care professional.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Bronchodilation with decreased airflow obstruction.
References in periodicals archive ?
In a third analysis the improvement of dyspnea (or shortness of breath), as measured by the Transition Dyspnea Index (TDI), was shown in COPD patients, compared to tiotropium, olodaterol and placebo.
Furthermore, consistent improvements in lung function with tiotropium plus olodaterol versus the monocomponents were demonstrated in GOLD A, B, C, and D, regardless of previous ICS use," Dr.
Three drugs are classified as respiratory agents: nintedanib (Ofev), olodaterol (Striverdi Respimat), and pirfenidone (Esbriet).
First Phase III data show lung function benefits of tiotropium + olodaterol fixed-dose combination (FDC) go beyond tiotropium (Spiriva) alone[sup.
2] agonists--the ultra-LABAs--and include indacaterol, carmoterol, vilanterol and olodaterol.
Studies showed consistent improvement in lung function, as measured by FEV1 AUC0-3, across a range of ages studied compared to tiotropium, olodaterol or placebo
1], improvement compared to tiotropium RESPIMAT, olodaterol RESPIMAT and placebo," said Richard Casaburi, PhD, MD, Professor and Associate Chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center.
In the absence of results from GlaxoSmithKline and Theravance's market-leading RELOVAIR program, top COPD trials data presented at the conference include results from Novartis' Phase III NVA237 GLOW2 trial and final Phase II data from Boehringer Ingelheim's olodaterol monotherapy program.
These data add to the growing body of evidence for STIOLTO RESPIMAT, which has been clinically proven to significantly improve lung function compared to tiotropium RESPIMAT, olodaterol RESPIMAT and placebo, with a similar safety profile.
In a second set of 48-week studies (NCT00793624 and NCT00796653), the same dose and delivery of olodaterol provided comparable improvements in lung function compared to 12 mcg formoterol twice daily in these COPD patients (n=904 and 934).
was a Phase 3 study in which 219 patients with moderate to very severe COPD were randomized to receive four of the following treatments for six weeks, each with a three-week period of no treatment in between: (1) placebo; (2) olodaterol 5 mcg; (3) tiotropium 2.