FDA Approves Stiolto Respimat

Stiolto Respimat

Generic Name: olodaterol and tiotropium bromide
Date of Approval: May 21, 2015
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

Stiolto Respimat is a combination of the long-acting beta2-adrenergic agonist olodaterol (Striverdi Respimat), and the anticholinergic agent tiotropium (Spiriva Respimat).

The U.S. Food and Drug Administration (FDA) has approved Stiolto Respimat (olodaterol and tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not indicated for the acute symptoms of COPD, or for asthma, and does not replace the use of a rescue inhaler.

Medication Guide

Read this Medication Guide before you start treatment 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.

Important information

Stiolto Respimat has been approved for the treatment chronic obstructive pulmonary disease (COPD) only. It is not to be used in the treatment of asthma.

Stiolto Respimat can cause serious side effects, including:

• People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as olodaterol (one of the medicines in Stiolto Respimat), have an increased risk of death from asthma problems.
• It is not known if LABA medicines, such as olodaterol, 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 Stiolto Respimat?

Stiolto Respimat contains two ingredients: olodaterol, a long-acting beta2-adrenergic agonist (LABA), and tiotropium, an anticholinergic agent.

It is used long term, two puffs once each day, in controlling symptoms in adults with COPD.

LABA and anticholinergic medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

Stiolto Respimat 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 this medicine is safe and effective in people with asthma. It should not be used in children. It is not known if Stiolto Respimat is safe and effective in children.

Who should not use this medicine?

Do not use Stiolto Respimat if:

• you have asthma.
• you are allergic to tiotropium, ipratropium, olodaterol, or any of the ingredients. See the end of this Medication Guide for a complete list of active and inactive ingredients.

Before using Stiolto 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
• have eye problems, such as glaucoma. This medicine can make your glaucoma worse.
• have prostate or bladder problems, or problems passing urine. This medicine can make these problems worse.
• have any other medical conditions
• 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 the active ingredients pass into your breast milk and if they can harm your baby.
• are allergic to Stiolto Respimat or any of its ingredients, any other medicines, or food products.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. Stiolto Respimat and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

• anticholinergics (including ipratropium, aclidinium, umeclidinium or another tiotropium-containing product such as Spiriva Respimat or Spiriva HandiHaler)
• atropine

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 Stiolto Respimat?

• Read the step-by-step instructions contained in the product package.
• The inhaler has a slow-moving mist that helps you inhale the medicine.
• Use Stiolto Respimat exactly as your healthcare provider tells you to use it.
• Use ONE dose (TWO puffs) of Stiolto Respimat, one time each day, at the same time of the day.
• If you miss a dose, take it as soon as you remember. Do not take more than ONE dose (TWO puffs) in 24 hours.
• Do not spray the inhaler in your eyes.
• Always use the new inhaler that is provided with each new prescription.
• Stiolto 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 this medicine, or other medicines used 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 Stiolto Respimat:
  • more often than prescribed for you, or
  • with other medicines that contain LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
• Call your healthcare provider or get emergency medical care right away if:
  • your breathing problems worsen during treatment
  • 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

Stiolto Respimat side effects

Stiolto Respimat can cause serious side effects, including:

• See Important information
• If your COPD symptoms worsen over time do not increase your dose. Call call your healthcare provider instead.
• sudden shortness of breath that may be life-threatening
• 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.
• heart problems including fast or irregular heartbeat, palpitations, chest pain, increased blood pressure
• new or worsening eye problems including acute narrow-angle glaucoma. Symptoms of acute narrow-angle glaucoma include eye pain or discomfort, blurred vision, seeing halos or colored images around lights, and red eyes. Call your healthcare provider right away if you have any of these symptoms. Use caution as some of these eye problems can affect your ability to drive and operate appliances and machinery.
• new or worsening urinary retention. Symptoms of urinary retention may include difficulty urinating, painful urination, urinating frequently, or urinating in a weak stream or drips. Call your healthcare provider right away if you have any of these symptoms.
• low blood potassium (which may cause symptoms of muscle spasm, muscle weakness or abnormal heart rhythm)
• high blood sugar

Common side effects of Stiolto Respimat include runny nose, cough, and back 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 Stiolto Respimat?

• Store Stiolto Respimat at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze the cartridge or the inhaler.
• Keep all medicines out of the reach of children.

General Information about the safe and effective use of Stiolto Respimat

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 toother people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Stiolto Respimat. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information that was written for healthcare professionals.

For more information, including a video demonstration on how to use Stiolto Respimat, go to www.stiolto.com.

What are the ingredients in Stiolto Respimat?

Active ingredients: olodaterol and tiotropium bromide

Inactive ingredients: water for injection, benzalkonium chloride, edetate disodium, and hydrochloric acid