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 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
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.