New Support Program Provides Free Medicine and Resources for People Living with COPD Prescribed STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray

RIDGEFIELD, Conn., Oct. 12, 2016 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., a research-based, global pharmaceutical company, and Ashfield Healthcare, a global provider of healthcare services, today announced a new patient support program, "STIOLTO Promise," which is designed to provide free medicine and resources to people who have been prescribed STIOLTO RESPIMAT to treat chronic obstructive pulmonary disease (COPD).

"Boehringer Ingelheim is proud to provide this new line-up of resources and services for people beginning treatment for COPD with STIOLTO RESPIMAT. At the start of this program, we already have more than 1,000 participants, and we expect many more to enroll," said Clare Burrows, vice president, Respiratory Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "For any treatment to be effective, it is important to start off on the right footing, and for COPD, we know this means understanding the disease, how to properly take their medicine, and initiating pulmonary exercises and other lifestyle behaviors that complement prescription medicine treatment. We designed the 'STIOLTO Promise' to support these goals."

The "STIOLTO Promise," which is open to all people who have been prescribed STIOLTO RESPIMAT for the first time by their healthcare provider, is a three-part program:

1. All participants in the program will receive a free 30-day supply of STIOLTO RESPIMAT, along with educational resources, which are shipped directly to each participant's home.  
2. After 7 to 10 days from the office visit with their healthcare provider, each participant will be offered an optional visit from a respiratory therapist or nurse, who will provide breathing exercises and assist with medication/inhaler questions.
3. Based on the at-home visit, the respiratory therapist or nurse will create a free assessment for the participant and their healthcare provider containing information on the participant's progress.

"In my practice, my patients and I work together to head-off any challenges associated with beginning a new COPD treatment plan, such as adjusting to lifestyle changes, adopting healthier habits and correctly using their inhaler," said Alan Kaufman, MD, Allergist-Immunologist, Center For Allergy & Asthma, Bronx, NY. "Several of my COPD patients recently began treatment with STIOLTO RESPIMAT, and I am pleased with the added education and support that they received through the 'STIOLTO Promise' program. In addition to the free 30-day supply of medicine, my patients really appreciated the information they learned during the at-home visit."

Depending on each patient's needs, they may take advantage of any or all three of the program elements. Only a healthcare provider can enroll participants into the "STIOLTO Promise." A healthcare provider may also enroll someone already taking STIOLTO RESPIMAT for a free 30-day supply as part of the "STIOLTO Promise." For more information, people should discuss the "STIOLTO Promise" with their healthcare providers, and healthcare providers should visit www.STIOLTOPromise.com for more information and to enroll patients.

Long-acting beta₂-adrenergic agonists, such as olodaterol, one of the active ingredients in STIOLTO RESPIMAT, increase the risk of asthma-related death. STIOLTO RESPIMAT is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. STIOLTO RESPIMAT is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. As with other inhaled medicines, STIOLTO RESPIMAT may cause paradoxical bronchospasm that may be life-threatening. The most common adverse reactions were nasopharyngitis, cough and back pain.

Please see complete Important Safety Information below.

STIOLTO RESPIMAT (www.STIOLTO.com) was approved in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. STIOLTO RESPIMAT is not indicated to treat asthma or acute deterioration of COPD. STIOLTO RESPIMAT has been clinically proven to help people living with COPD breathe better, while improving their health-related quality of life.

Ashfield Healthcare will hire and train 38 respiratory therapists and nurses and coordinate the at-home visits and post-visit assessments. Eagle Pharmacy, an online-based national pharmacy, will process the new STIOLTO RESPIMAT prescriptions and arrange for the free delivery of the 30-day supply.

"We are proud to partner with Boehringer Ingelheim Pharmaceuticals, Inc. on this tremendous initiative that will bring free medicine for the first 30 days and support services to people living with COPD who have been prescribed STIOLTO RESPIMAT," said Mike Stout, CEO, Ashfield Healthcare. "Both Boehringer Ingelheim and Ashfield Healthcare are committed to finding new ways to bring healthcare to people across the country."

About the RESPIMAT Inhaler
RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, was designed to get medicine deep into patients' lungs as a slow-moving mist. The slow moving mist of the RESPIMAT inhaler provides patients with enough time to breathe in the medication. The RESPIMAT inhaler operates independent of inspiratory effort, helping patients effectively breathe the medicine into their lungs while minimizing inhalation effort.

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

Boehringer Ingelheim's Respimat family of products includes five FDA-approved medicines for COPD and asthma.

INDICATION for STIOLTO RESPIMAT
STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.

STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta₂-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

STIOLTO is not for treating 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.

Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.

IMPORTANT SAFETY INFORMATION

People with asthma who take long-acting beta₂-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include 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. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.

Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins, and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.

STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar, or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.

STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO can cause new or worsened urinary retention.  Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.

Do not spray STIOLTO into your eyes.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.

Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Information, including boxed WARNING.

About COPD
Chronic obstructive pulmonary disease (COPD) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.

SOURCE Boehringer Ingelheim Pharmaceuticals

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