SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray Now Available in the United States

New choice between mist and dry powder inhalers for tiotropium

News provided by

Boehringer Ingelheim Pharmaceuticals, Inc.

Jan 21, 2015, 09:02 ET

RIDGEFIELD, Conn., Jan. 21, 2015 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray is now available by prescription through retail pharmacies across the United States.

SPIRIVA RESPIMAT Inhalation Spray is now available by prescription through retail pharmacies across the United States for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients.

SPIRIVA RESPIMAT was recently approved by the U.S. Food and Drug Administration (FDA) for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients. Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder), which is the number one branded prescription medication for COPD maintenance in the United States, will continue to be available for patients.

"For 10 years, SPIRIVA HandiHaler has been a trusted maintenance therapy for patients with COPD, and Boehringer Ingelheim is proud to now offer another inhaler choice, SPIRIVA RESPIMAT," said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. "SPIRIVA RESPIMAT represents Boehringer Ingelheim's continuing commitment to the COPD community to provide new treatment options."

SPIRIVA RESPIMAT was developed to deliver medication via a slow-moving mist that helps patients inhale the medication. SPIRIVA RESPIMAT delivers medication independent of inspiratory 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 should be at least as long as the spray duration (1.5 seconds).

Boehringer Ingelheim will offer a savings card that will allow eligible patients to get SPIRIVA RESPIMAT for as low as $10, depending on their insurance provider. The savings card is available at www.SPIRIVA.com and can be activated at most pharmacies. For more information about Boehringer Ingelheim's patient assistance program, BI Cares, please visit www.BIPatientAssistance.com.

The RESPIMAT is the platform inhaler for the Boehringer Ingelheim suite of inhaled bronchodilators, including approved and investigational therapies.

SPIRIVA RESPIMAT is the third FDA-approved product delivered by the RESPIMAT. The RESPIMAT is the only inhaler available in the United States that uses mechanical energy to generate a slow-moving mist to deliver the medication, and the inhaler also has a dose indicator that helps keep track of approximately how much medicine is left.

About Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder) and SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray

Indication
Spiriva^® HandiHaler^® (tiotropium bromide inhalation powder) and SPIRIVA^® RESPIMAT^® (tiotropium bromide) Inhalation Spray are prescription medicines used once daily (maintenance medicines) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema.

SPIRIVA HandiHaler and SPIRIVA RESPIMAT also reduce the likelihood of flare-ups (COPD exacerbations).

Important Safety Information for SPIRIVA HandiHaler and SPIRIVA RESPIMAT
Do not use SPIRIVA HandiHaler or SPIRIVA RESPIMAT if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and get immediate medical help.

Before using SPIRIVA HandiHaler, tell your doctor if you have a severe allergy to milk proteins.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause your breathing to suddenly get worse (bronchospasm). If this happens, stop taking your medicine, use your rescue inhaler and call your doctor right away or go to the nearest emergency room.

Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine or blockage in your bladder.

Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA HandiHaler or SPIRIVA RESPIMAT can increase side effects.

Do not take SPIRIVA HandiHaler and SPIRIVA RESPIMAT together.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can increase the pressure in your eyes (acute narrow-angle glaucoma) 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.

SPIRIVA HandiHaler or SPIRIVA RESPIMAT can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away.

Dizziness and blurred vision may occur with SPIRIVA HandiHaler or SPIRIVA RESPIMAT. If you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.

The most common side effects with SPIRIVA HandiHaler include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate and blurred vision.

The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HandiHaler device. Do not use your HandiHaler device to take other medications.

Do not spray SPIRIVA RESPIMAT into your eyes as this may cause blurring of vision and pupil dilation.

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.

For full prescribing information, please visit www.SPIRIVA.com, or call 1-800-542-6257 option #4.

Please click for full Prescribing Information for SPIRIVA HandiHaler and for SPIRIVA RESPIMAT.

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.

Leading respiratory forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.com

Photo - http://photos.prnewswire.com/prnh/20150120/170181

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.