Striverdi Respimat (olodaterol) FDA Approval, Dosing, Cost, Side Effects, Prescribing Information for COPD | Caroline Bett, Pharm.D. | RxEconsult
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Striverdi Respimat (olodaterol) for COPD: FDA Approval, Side Effects, Dosing and Cost Category: Chronic obstructive pulmonary disease (COPD) and Asthma by - August 9, 2014 | Views: 22216 | Likes: 1 | Comment: 0  

Brand name: Striverdi Respimat Inhalation Spray
Generic name: olodaterol  

Striverdi Respimat, olodatreol

Medication Class: Long-acting beta2-adrenergic agonists (LABA)
Similar drugs: Arformoterol (Brovana), Formoterol (Foradil Aerolizer), Indacaterol (Arcapta Neohaler), Salmeterol (Serevent Diskus)
Manufacturer: Boehringer Ingelheim
Approval Date: July 31, 2014

What is Striverdi Respimat and its mechanism of action?

Striverdi Respimat is a long-acting beta-2 agonist (LABA) oral inhaler. It works by increasing the activity of adenyl cyclase, an enzyme that increases cyclic adenosine monophosphate (cAMP). cAMP is a chemical that helps to stimulate beta-2 receptors in the lungs and smooth muscles of the bronchioles (airway). When these beta-2 receptors are stimulated, the airway muscles relax, increasing airflow in the lungs.

After inhalation, the maximum concentration of olodaterol is reached within 10 to 20 minutes. With daily use, steady state plasma concentrations are reached after 8 days.

Chronic obstructive pulmonary (COPD) is a disease that causes breathing difficulties. It can also cause coughing, wheezing, shortness of breath and chest tightness. The airway may also produce a lot of mucus, causing it to become clogged. Over time, the amount of air flowing in and out of the airways reduces because the airways become rigid, thick and inflamed.  Cigarette smoking is the main cause of COPD.

COPD is a progressive disease, meaning it gets worse over time. There are types of COPD: chronic bronchitis and emphysema. Chronic bronchitis refers to when the airway is irritated and becomes thick and inflamed. This causes production of a lot of mucus, making it difficult to breath. With emphysema, the walls between the air sacs (where exchange of oxygen and carbon dioxide take place) become stiff. This reduces the amount of air in the lungs. It is common for people with COPD to have both chronic bronchitis and emphysema.

Striverdi Respimat opens up the airways and helps people with COPD breathe more easily.

What is Striverdi Respimat approved for treating?

Striverdi Respimat is used for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

How effective is Striverdi Respimat?

3,014 patients were treated in 8 clinical trials to determine how well Striverdi Respimat works compared to placebo. Dosing occurred at approximately the same time of the day in the morning.

The patients selected were 40 years of age or older and had COPD as well as a smoking history of 10 pack-years or more. They also had moderate to very severe pulmonary impairment (post-bronchodilator FEV1 less than 80% of predicted normal (GOLD II-IV) and a post-bronchodilator FEV1 to FVC ratio of less than 70%.

After 12 weeks of treatment, Striverdi Respimat showed significant improvements in trough FEV1 compared to placebo. 1 hour after dosing, FEV1 with Striverdi Respimat was approximately 1.41 L compared to 1.25 L for placebo. 12 hours after dosing, FEV1 with Striverdi Respimat was approximately 1.30 L compared to 1.16 L for placebo.

Interesting facts about Striverdi Respimat

  • The respimat device produces a slow-moving mist that makes inhalation easier
  • Striverdi Respimat should not be used to treat asthma attacks
  • It is not approved for use in children

What are the side effects of Striverdi Respimat?

Common side effects include nasopharyngitis (common cold), upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).

Other side effects include pneumonia, constipation, and pyrexia (fever)

During clinical trials, lung cancers were reported in 6 patients who received 10 mcg of Striverdi Respimat, 3 patients who received 5 mcg of Striverdi Respimat, and 2 patients who received placebo.

What is the dosage of Striverdi Respimat?

Striverdi Respimat is available in an inhaler that delivers 2.7 mcg of olodaterol hydrochloride in each actuation. This is equivalent to 2.5 mcg of olodaterol.  

Two actuations equal one dose. The recommended dose is 2 inhalations (5 mcg of olodaterol) once a day at the same time of the day. More than two inhalations should not be used in 24 hours.

What are Striverdi Respimat drug interactions?

The following are some examples of drugs that may interact with Striverdi Respimat.

Beta-blockers such as propranolol can block or decrease the effects of Striverdi Respimat and should be avoided. A cardioselective beta-blocker such as metoprolol might be a better choice.

Adrenergic drugs such as arformoterol should be used with caution because they can increase the effects of Striverdi Respimat.

Non-potassium sparing diuretics (such as furosemide and hydrochlorothiazide) increase the risk of hypokalemia (lower than normal amount of potassium in the blood) when combined with Striverdi Respimat. Severe hypokalemia can affect heart function.

Use of Striverdi Respimat with tricyclic antidepressants (such as amitriptyline) and other drugs (e.g., ketoconazole) that prolong QTc interval (abnormal heart rhythm) may also affect heart function.

Other medications can interact with Striverdi Respimat. Patients should consult their physician or pharmacist to confirm drug interactions with specific products.

What are the warnings and precautions of Striverdi Respimat?

Striverdi Respimat increases the risk of asthma-related death.  It should not be used in patients with asthma without use of a long-term asthma control medication (Black box warning).

Striverdi Respimat should not be used by patients with rapidly deteriorating or life-threatening COPD. Additionally, it should not be used for the relief of acute symptoms, such as an asthma attack.

Striverdi Respimat  should not be used more often, or at a higher dose than prescribed. This can lead to negative effects on heart function and death.

It should be used with caution by patients with heart or seizure disorders. If increases in heart rate, blood pressure or frequency of seizures occur, Striverdi Respimat may need to be discontinued.

If immediate hypersensitivity reactions or life-threatening paradoxical bronchospasm occur after administration of Striverdi Respimat, it should be discontinued immediately

Pregnancy category C: Striverdi Respimat has not been studied in pregnant women and should be used only if benefits outweigh the risks.

Nursing mothers:  It has not been studied in lactating women. Animal studies suggest that Striverdi Respimat is likely to be excreted in human breast milk. Therefore, caution should be used if administered during nursing.

What is the cost of Striverdi Respimat?

The cost of Striverdi Respimat has not yet been finalized.

Resources

Olodaterol. In: Clinical Pharmacology. Tampa (FL): Elsevier/Gold Standard. (Updated Aug 1, 2014). 

Striverdi Respimat (olodaterol) Inhalation Spray. FDA Advisory Committee Meeting.  

Striverdi Respimat (olodaterol) Prescribing Information (Package Insert)

What Is COPD? National Heart, Lung and Blood Institute



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