This way to better breathing

Transcription

1 STRIVERDI RESPIMAT (olodaterol) Inhalation Spray is a long-term, once-daily prescription medicine for adults that controls symptoms of chronic obstructive pulmonary disease (COPD) and can help you breathe better by relaxing airways. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you. Do not use STRIVERDI RESPIMAT if you have asthma. STRIVERDI RESPIMAT is approved to treat COPD only. This way to better breathing IMPORTANT SAFETY INFORMATION People with asthma who take long-acting beta 2 -agonist (LABA) medicines, such as STRIVERDI RESPIMAT, 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.

2 STRIVERDI RESPIMAT (olodaterol) Inhalation Spray is a long-term, once-daily prescription medicine for adults that controls symptoms of chronic obstructive pulmonary disease (COPD) and can help you breathe better by relaxing airways. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you. Do not use STRIVERDI RESPIMAT if you have asthma. STRIVERDI RESPIMAT is approved to treat COPD only. This way to better breathing IMPORTANT SAFETY INFORMATION People with asthma who take long-acting beta 2 -agonist (LABA) medicines, such as STRIVERDI RESPIMAT, 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.

3 BETTER BREATHING with STRIVERDI RESPIMAT Breathing with COPD is hard, but it can get easier If you ve been diagnosed with chronic obstructive pulmonary disease (COPD), then you know it is a condition that affects your lungs and makes it hard for you to breathe. Over time, it can cause breathing to get worse. While the loss of lung function caused by COPD is not reversible, COPD symptoms can be treated with medications like STRIVERDI RESPIMAT. COPD includes chronic bronchitis, emphysema, or both. The most common symptoms include: Shortness of breath Persistent coughing or a cough with or without mucus Chest tightness 2 INDICATION Striverdi Respimat (olodaterol) Inhalation Spray is a prescription medicine used long term, inhaled one time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). Long-acting beta 2 -agonist (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. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine (short-acting beta 2 -agonist) with you to treat sudden symptoms. INDICATION (CONTINUED) Do not use STRIVERDI RESPIMAT if you have asthma. STRIVERDI RESPIMAT is approved to treat COPD only. 3

4 Breathe better with STRIVERDI RESPIMAT When you have COPD, breathing better is an important goal. STRIVERDI RESPIMAT is a once-daily maintenance medication approved to help treat the symptoms of COPD. Studies show that STRIVERDI RESPIMAT: Opened narrowed airways Improved lung function Decreased the need for rescue inhalers Lasted 24 hours and started working in as little as 5 minutes. STRIVERDI RESPIMAT is not for use to treat sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms STRIVERDI RESPIMAT helps the muscles around the airways in your lungs stay relaxed to prevent COPD symptoms, such as wheezing, cough, chest tightness, and shortness of breath. If your doctor has prescribed you STRIVERDI RESPIMAT along with your current maintenance medication, be sure to continue taking all of your medications as prescribed by your doctor. If you have any questions about your COPD treatment, be sure to talk to your doctor. BREATHING BETTER IS JUST A CLICK AWAY STRIVERDI.COM IMPORTANT SAFETY INFORMATION People with asthma who take long-acting beta 2 -agonist (LABA) medicines, such as STRIVERDI RESPIMAT, 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. IMPORTANT SAFETY INFORMATION (CONTINUED) STRIVERDI RESPIMAT has been approved for chronic obstructive pulmonary disease (COPD) only. STRIVERDI RESPIMAT is NOT to be used in asthma. 4 5

5 See the mist STRIVERDI RESPIMAT delivers your medication in a slow-moving mist You may notice that STRIVERDI RESPIMAT delivers your medication in a mist. Instead of propellants, this inhaler uses a spring mechanism to release the medicine. SEE STRIVERDI RESPIMAT IN ACTION AND GET INSTRUCTIONS FOR USE STARTING ON PAGE 8 OF THIS BROCHURE. FOR FULL INSTRUCTIONS FOR USE, SEE STRIVERDI.COM A helpful way to remember the steps for daily dosing for STRIVERDI RESPIMAT is T.O.P.: Turn, Open, Press. T URN the OPEN P clear base. the cap and close lips around mouthpiece. RESS the doserelease button and inhale. These steps should be performed two times to receive the proper dose of medicine. Learn how to prepare your inhaler for first-time use on the next page. STRIVERDI RESPIMAT must be prepared and primed before each use. Please see full Instructions for Use for additional details on preparing and priming the inhaler, and how to use the inhaler for daily use. IMPORTANT SAFETY INFORMATION Do not use STRIVERDI RESPIMAT more often or at higher doses than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. IMPORTANT SAFETY INFORMATION (CONTINUED) Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine and it does not make your breathing problems better. 6 7

6 Using STRIVERDI RESPIMAT HOW TO USE STRIVERDI RESPIMAT FOR ORAL INHALATION ONLY Do not spray STRIVERDI RESPIMAT into your eyes. For complete instructions, you should read the Instructions for Use enclosed with your prescription before you start using STRIVERDI RESPIMAT and each time you get a refill. Please refer to the pictures on this page to become familiar with the components of your inhaler. The following instructions show you how to prepare and prime for first-time use, and how to use the inhaler for daily dosing. Cap Mouthpiece Air vent (one on each side) Dose-release button Safety catch Clear base Piercing element FRONT VIEW Dose indicator Discard by BACK VIEW Black arrows CARTRIDGE Please see complete Important Safety Information on pages of this brochure. Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Information, including Boxed Warning, in pocket. PREPARE FOR FIRST-TIME USE 1. With the yellow cap closed, press the safety catch while pulling off the clear base. Be careful not to touch the piercing element located inside the bottom of the clear base. 2. Write the discard by date on the label of the inhaler. The discard by date is 3 months from the date the cartridge is inserted. 3. Take the cartridge out of the box. Push the narrow end of the cartridge into the inhaler. The base of the cartridge will not sit flush with the inhaler. About 1/8 of an inch will remain visible when the cartridge is correctly inserted. The cartridge can be pushed against a firm surface to make sure that it is correctly inserted. Do not remove the cartridge once it has been inserted into the inhaler. 4. Put the clear base back into place. Do not remove the clear base again. Your inhaler should not be taken apart after you have inserted the cartridge and put the clear base back Cartridge Cartridge Safety catch Clear base Safety catch Clear base 8 9

7 Using STRIVERDI RESPIMAT (continued) PRIME FOR FIRST-TIME USE The following steps are needed to fill the dosing system the first time you use it and will not affect the number of doses available. After preparation and initial priming, your STRIVERDI RESPIMAT inhaler will be able to deliver the labeled number of doses (30 or 14). DAILY DOSING Proper priming of the inhaler is important to make sure the correct amount of medicine is delivered. 5. Hold the inhaler upright with the yellow cap closed, to avoid accidental release of dose. Turn the clear base in the direction of the black arrows on the label until it clicks (half a turn). 5 6 Yellow cap A. Hold the inhaler upright with the yellow cap closed, so you do not accidentally release a dose of medicine. TURN the clear base in the direction of the black arrows on the label until it clicks (half a turn). B. Flip the yellow cap until it snaps fully OPEN. Breathe out slowly and fully, and then close your lips around the end of the mouthpiece without covering the air vents. Point your inhaler to the back of your throat. While taking a slow, deep breath through your mouth, PRESS the dose-release button and continue to breathe in slowly for as long as you can. A B Air vent Yellow cap 6. Flip the yellow cap until it snaps fully open. Hold your breath for 10 seconds or for as long as comfortable. 7. Point the inhaler toward the ground (away from your face). Press the dose-release button. Close the yellow cap. Repeat steps 5, 6, and 7 until a spray is visible. Once the spray is visible, you must repeat steps 5, 6, and 7 three more times to make sure the inhaler is prepared for use. Your inhaler is now ready to use. 7 Dose-release button Repeat step A and step B so that you get the full dose. Close the yellow cap until you use your inhaler again. As described on page 7, a helpful way to remember the steps for daily dosing is to remember T.O.P. IF YOUR STRIVERDI RESPIMAT HAS NOT BEEN USED... For more than 3 days, spray 1 puff toward the ground to prepare the inhaler for use. 10 For more than 21 days, repeat steps 5, 6, and 7 until a spray is visible. Then repeat steps 5, 6, and 7 three more times to prepare the inhaler for use. 11

8 Care of STRIVERDI RESPIMAT and Important Safety Information HOW SHOULD I CARE FOR MY STRIVERDI RESPIMAT INHALER? Clean the mouthpiece, including the metal part inside the mouthpiece, with a damp cloth or tissue only, at least 1 time a week. Any minor discoloration in the mouthpiece does not affect your STRIVERDI RESPIMAT inhaler. If the outside of your STRIVERDI RESPIMAT inhaler gets dirty, wipe it with a damp cloth. IMPORTANT SAFETY INFORMATION (CONTINUED) Do not use STRIVERDI RESPIMAT more often or at higher doses than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine and it does not make your breathing problems better. Tell your doctor about all of your health conditions before using STRIVERDI RESPIMAT, including if you have a heart condition, high blood pressure, thyroid problems, diabetes, or if you suffer from seizures. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm, or high blood sugar. STRIVERDI RESPIMAT can cause serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your doctor or get emergency medical care if you get any symptoms of a serious allergic reaction. The most common side effects are runny nose, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint 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 or call FDA Read the step-by-step Patient Instructions for Use for using STRIVERDI RESPIMAT before you use your inhaler. 12 HOW SHOULD I STORE MY STRIVERDI RESPIMAT INHALER? Store STRIVERDI RESPIMAT at room temperature from 59 F to 86 F (15 C to 30 C). Do not freeze your STRIVERDI cartridge and RESPIMAT inhaler. Keep your STRIVERDI RESPIMAT and all medicines out of the reach of children. INDICATION Striverdi Respimat (olodaterol) Inhalation Spray is a prescription medicine used long term, inhaled one time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). Long-acting beta 2 -agonist (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. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine (short-acting beta 2 -agonist) with you to treat sudden symptoms. Do not use STRIVERDI RESPIMAT if you have asthma. STRIVERDI RESPIMAT is approved to treat COPD only. IMPORTANT SAFETY INFORMATION People with asthma who take long-acting beta 2 -agonist (LABA) medicines, such as STRIVERDI RESPIMAT, 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. STRIVERDI RESPIMAT has been approved for chronic obstructive pulmonary disease (COPD) only. STRIVERDI RESPIMAT is NOT to be used in asthma. 13

9 Notes 14 15

10 These savings are brought to you by STRIVERDI RESPIMAT Start saving with your first prescription You may be eligible to receive a FREE 3-month supply of STRIVERDI RESPIMAT or pay a $0 copay for 1 year. Visit and enter the Card ID located on the front of your STRIVERDI RESPIMAT Savings Card. Once activated, bring your card to the pharmacy. Full Terms and Conditions for these savings are available at Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Copyright 2014, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. Printed in the U.S.A. (11/14) STR594802CONS