Olodaterol

 Maintenance Treatment of COPD

Olodaterol is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

 Important Limitations of Use

Olodaterol is not indicated to treat acute deteriorations of COPD.

Olodaterol is not indicated to treat asthma. The safety and effectiveness of Olodaterol in asthma have not been established.

Olodaterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Olodaterol is used to prevent bronchoconstriction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Olodaterol will not treat a bronchospasm attack that has already begun.

Olodaterol is not for use in treating asthma.

Olodaterol may also be used for purposes not listed in this medication guide.

The recommended dose of Olodaterol is two inhalations once-daily at the same time of the day. Do not use Olodaterol more than two inhalations every 24 hours.

Prior to first use, the Olodaterol cartridge is inserted into the Olodaterol inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use.

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally-impaired patients. There are no data available for use of Olodaterol in severe hepatically impaired patients.

How supplied

Dosage Forms And Strengths

Olodaterol consists of a Olodaterol inhaler and an aluminum cylinder (Olodaterol cartridge) containing Olodaterol (as the hydrochloride). The Olodaterol cartridge is intended for use with the Olodaterol inhaler only.

Each actuation from the Olodaterol inhaler delivers 2.7 mcg Olodaterol hydrochloride, equivalent to 2.5 mcg Olodaterol. Two actuations equal one dose.

Storage And Handling

Olodaterol Inhalation Spray is supplied in a labeled carton containing one Olodaterol cartridge and one Olodaterol inhaler.

The Olodaterol cartridge is an aluminum cylinder with a tamper protection seal on the cap. The Olodaterol cartridge is only intended for use with the Olodaterol inhaler.

The Olodaterol inhaler is a cylindrical-shaped plastic inhalation device with a gray-colored body and a clear base. The clear base is removed to insert the cartridge. The inhaler contains a dose indicator. The yellow colored cap and the written information on the label of the gray inhaler body indicates that it is labeled for use with the Olodaterol cartridge.

Olodaterol Inhalation Spray is available as: Olodaterol Inhalation Spray: 60 metered actuations (NDC 0597-0192-61)

The Olodaterol cartridge has a net fill weight of at least 4 grams and when used with the Olodaterol inhaler, is designed to deliver the labeled number of metered actuations after preparation for use.

When the labeled number of metered actuations has been dispensed from the inhaler, the Olodaterol locking mechanism will be engaged and no more actuations can be dispensed.

After assembly, the Olodaterol inhaler should be discarded at the latest 3 months after first use or when the locking mechanism is engaged, whichever comes first.

Keep out of reach of children. Do not spray into eyes.

Storage

Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F). Avoid freezing.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Revised: Jun 2016

See also:
What is the most important information I should know about Olodaterol?

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.

Documentation of allergenic cross-reactivity for sympathomimetics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Use Olodaterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Olodaterol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Olodaterol refilled.
• Olodaterol is for inhalation only. Do not spray into the eyes.
• Before first using Olodaterol, put the cartridge into the inhaler.
• You will need to prime the inhaler. Point it toward the ground and spray until you see medicine come out. After you see the medicine come out, spray 3 more times. Do this before first using Olodaterol and if it is not used for more than 21 days.
• If Olodaterol is not used for more than 3 days, spray once before using.
• Use the new inhaler that comes with each refill.
• Have your inhaler use checked with your doctor at each visit. Read and follow facts on how to use the inhaler. Make sure you use the inhaler the right way.
• Use Olodaterol at the same time of day.
• Use Olodaterol on a regular schedule to get the most benefit from it.
• If you miss a dose of Olodaterol, use it as soon as possible. Do not use more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use Olodaterol.

Use: Labeled Indications

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

See also:
What other drugs will affect Olodaterol?

Adrenergic Agents: Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of Olodaterol.

Xanthine Derivatives, Steroids or Diuretics: Concomitant treatment with xanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate any hypokalemic effect of adrenergic agonists.

Beta-Blockers: Beta-adrenergic blockers may weaken or antagonise the effect of Olodaterol. Therefore, Olodaterol should only be given together with beta-adrenergic blockers (including eye-drops) if there are compelling reasons for their use. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

MAO Inhibitors and Tricyclic Antidepressants, QTc Prolonging Drugs: Monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of Olodaterol on the cardiovascular system.

Pharmacokinetic Drug Drug Interactions: No relevant effect on systemic exposure to Olodaterol has been observed in drug-drug interaction studies with co-administration of fluconazole, used as model inhibitor of CYP2C9.

Co-administration of ketoconazole as potent P-gp and CYP inhibitor increased systemic exposure to Olodaterol by approximately 70%. No dose adjustment is necessary.

Co-administration of Olodaterol and tiotropium had no relevant effect on the systemic exposure to either of the two drugs.

In vitro investigations have shown that Olodaterol does not inhibit CYP enzymes or drug transporters at the plasma concentrations achieved in clinical practice.

See also:
What are the possible side effects of Olodaterol?

Long-acting beta2-adrenergic agonists, such as Olodaterol, increase the risk of asthma-related death. Olodaterol is not indicated for the treatment of asthma.

 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The Olodaterol clinical development program included seven dose-ranging trials and eight confirmatory trials. Four of the confirmatory trials were 6-week cross-over trials and four were 48-week parallel group trials. Adverse reactions observed in the dose-ranging trials and four 6-week cross-over trials were consistent with those observed in the 48-week parallel group trials, which formed the primary safety database.

The primary safety database consisted of pooled data from the four 48-week double-blind, active and placebo-controlled, parallel group confirmatory clinical trials. These trials included 3104 adult COPD patients (77% males and 23% females) 40 years of age and older. Of these patients, 876 and 883 patients were treated with Olodaterol 5 mcg and 10 mcg once-daily, respectively. The Olodaterol groups were composed of mostly Caucasians (66%) with a mean age of 64 years and a mean percent predicted FEV1 at baseline of 44% for both the 5 mcg and 10 mcg treatment groups. Control arms for comparison included placebo in all four trials plus formoterol 12 mcg in two trials.

In these four clinical trials, seventy-two percent (72%) of patients exposed to any dose of Olodaterol reported an adverse reaction compared to 71% in the placebo group. The proportion of patients who discontinued due to an adverse reaction was 7.2% for Olodaterol treated patients compared to 8.8% for placebo treated patients. The adverse reaction most commonly leading to discontinuation was worsening COPD. The most common serious adverse reactions were COPD exacerbation, pneumonia, and atrial fibrillation.

Table 1 shows all adverse drug reactions reported by at least 2% of patients (and higher than placebo) who received Olodaterol 5 mcg during the 48-week trials.

Table 1 Number and frequency of adverse drug reactions greater than 2% (and higher than placebo) in COPD patients exposed to Olodaterol 5 mcg: Pooled data from the four 48-week, double-blind, active- and placebo-controlled clinical trials in COPD patients 40 years of age and older

Additional adverse reactions that occurred in greater than 2% (and higher than placebo) of patients exposed to Olodaterol 10 mcg were pneumonia, constipation, and pyrexia.

Lung cancers were reported in 6 (0.7%), 3 (0.3%), and 2 (0.2%) patients who received Olodaterol 10 mcg, 5 mcg, and placebo, respectively.

Each actuation delivers Olodaterol 2.5 mcg/puff (2 puffs comprise 1 medicinal dose) from the mouthpiece and is equivalent to Olodaterol HCl 2.7 mcg. One dose of Olodaterol 5 mcg consists of 2 actuations.

It also contains the following excipients: Benzalkonium chloride, disodium edetate, water, purified, anhydrous citric acid.

Olodaterol solution for inhalation is composed of an aqueous, multi-dose solution of Olodaterol hydrochloride for oral inhalation, delivered by a Respimat inhaler, which provides an aerosolized mist of appropriate particle size for delivery to the lung.

Olodaterol solution for inhalation is a clear, colourless solution of Olodaterol hydrochloride contained in a cartridge. The solution is filled in a plastic container which is crimped into an aluminium cylinder to form the cartridge.

The Olodaterol is a soft mist inhaler delivering Olodaterol solution for inhalation.

The delivered dose is the dose which is available for the patient after passing the mouthpiece.