Generic Name: olodaterol
Date of Approval: July 31, 2014
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Chronic Obstructive Pulmonary Disease
FDA Approves Striverdi Respimat
The U.S. Food and Drug Administration has approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The active ingredient olodaterol is a long-acting beta2-agonist (LABA) which works by helping the muscles around the airways in the lungs stay relaxed to prevent symptoms. It is delivered via a propellant-free inhaler that generates a soft, slow-moving mist.
Other LABAs approved for use in COPD include salmeterol (Serevent), formoterol (Foradil, Perforomist) and arformoterol (Brovana). While these all medicines are used twice daily, the introduction of indacaterol (approved as Arcapta Neohaler in 2011) was the first ultra-long-acting beta-adrenoceptor agonist to offer the convenience of once daily dosing. Vilanterol, a the second once-daily LABA, was approved in combination as Breo Ellipta (fluticasone/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol) in 2013.
As the third once-daily LABA, olodaterol (Striverdi Respimat) can be used once daily over a long period of time.
Like all LABAs, the drug carries a boxed warning stating the increased risk of asthma-related death. It is not approved to treat asthma.
The most common side effects reported by people using Striverdi Respimat in the clinical study were nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia (joint pain).
Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
Read the Medication Guide that comes with your prescription before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
Striverdi Respimat has been approved for chronic obstructive pulmonary disease (COPD) only. It is NOT to be used in asthma.
Striverdi Respimat and LABA medicines can cause serious side effects, including:
- People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines have an increased risk of death from asthma problems.
- It is not known if LABA medicines increase the risk of death in people with COPD.
- Get emergency medical care if:
- breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve your breathing problems
What is Striverdi Respimat?
Striverdi Respimat is used long term, once a day, in controlling symptoms of COPD in adults with COPD.
LABA medicines such as Striverdi Respimat help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
This medicine is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
It is not known if Striverdi Respimat is safe and effective in people with asthma.
It should not be used in children. It is not known if it is safe and effective in children.
Who should not use Striverdi Respimat?
Do not use this medicine if you have asthma.
What should I tell my healthcare provider before using Striverdi Respimat?
Tell your healthcare provider about all of your health conditions, including if you:
- have heart problems
- have high blood pressure
- have seizures
- have thyroid problems
- have diabetes
- are pregnant or planning to become pregnant. It is not known if this medicine can harm your unborn baby.
- are breastfeeding. It is not known if this medicine passes into your breast milk and if it can harm your baby.
- are allergic to olodaterol or any of the other ingredients, any other medicines, or food products.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Striverdi Respimat and certain other medicines may interact with each other. This may cause serious side effects.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use this medicine?
- The Striverdi Respimat inhaler has a slow-moving mist that helps you inhale the medicine.
- Read the step-by-step instructions for use at the end of this Medication Guide.
- Use the inhaler exactly as your healthcare provider tells you to use it.
- Use one dose (2 puffs) of Striverdi Respimat, once a day, at the same time each day.
- If you miss a dose, take it as soon as you remember. Do not take more than one dose (2 puffs) in 24 hours.
- Do not spray in your eyes.
- Always use the new inhaler that is provided with each new prescription.
- Striverdi Respimat does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
- Do not stop using any medicine to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
- Do not use this medicine:
- more often than prescribed for you, or
- with other LABA medicines
- Call your healthcare provider or get emergency medical care right away if:
- your breathing problems worsen with Striverdi Respimat
- you need to use your rescue medicine more often than usual
- your rescue inhaler medicine does not work as well for you at relieving your symptoms
Striverdi Respimat side effects
Striverdi Respimat can cause serious side effects, including:
- See Important information
- If your COPD symptoms worsen over time do not increase your dose, instead call your healthcare provider.
- sudden shortness of breath that may be life-threatening
- fast or irregular heartbeat, palpitations
- chest pain
- increased blood pressure
- low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
- high blood sugar
- serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
Common side effects include:
- runny nose
- upper respiratory tract infection
- urinary tract infection
- back pain
- joint pain
Tell your healthcare provider about any side effect that bothers you or that does not go away.
This is not a complete list of side effects. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Striverdi Respimat?
- Store at room temperature between 59°F to 86°F (15°C to 30°C).
- Do not freeze the cartridge or the inhaler.
- Keep all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information written for healthcare professionals.
What are the ingredients?
Active ingredient: olodaterol
Inactive ingredients: water, benzalkonium chloride, edetate disodium, and anhydrous citric acid