Experience the Powder of Non-nebulized Pa Treatment

Transcription

1 For people 6 years and older with cystic fibrosis (CF), Pseudomonas aeruginosa (Pa), and FEV 1 25% to 80% predicted and who do not have Burkholderia cepacia. Experience the Powder of Non-nebulized Pa Treatment Scan with INDICATION TOBI Podhaler (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial.

2 Introducing TOBI Podhaler The first and only dry-powder inhaled antibiotic for appropriate people with CF and Pa Why TOBI Podhaler May Be Right for You Nebulized therapies have been used for many years. They can take a lot of time with administration, setup, cleanup, and disinfection. They also need to be refrigerated and require batteries or another power source. TOBI Podhaler allows for Pseudomonas aeruginosa (Pa) treatment without a nebulizer. A full dose can be administered in 2 to 7 minutes. TOBI Podhaler can be used by people 6 years and older with cystic fibrosis (CF), Pa, and FEV 1 25% to 80% predicted and who do not have Burkholderia cepacia. Portable Disposable Administered in 2 to 7 minutes No battery or power source No refrigeration No compressor TOBI Podhaler is a dry-powder treatment delivered in a disposable device that does not require disinfection TOBI Podhaler is taken twice a day, and needs little setup and cleanup In clinical trials, administration time ranged from 2 to 7 minutes 0" 1/2 1" 1/2 2" 1/2 3" 1/2 4" 1/2 5" Actual size Scan with 2 Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing.

3 Understanding Pseudomonas aeruginosa (Pa) What is Pa? Pseudomonas aeruginosa (soo-doh-moh-nass ah-ru-ji-noh-sa) or Pa for short is a type of bacteria that is found everywhere. It s in the air, ground, and water. It doesn t usually make healthy people sick. But it can cause serious health risks in those with CF. People with CF are more likely than healthy people to have Pa in their lungs. That s because the bacteria live in the thick mucus that collects there. In general, the chance of having Pa in the lungs increases with age in people with CF Percent of People With CF and Pa < Age (Years) What are the effects of Pa? Pa can cause lung function to get worse in people with CF. It s also a leading cause of chronic lung infection in those with CF. A chronic lung infection is one that doesn t go away. When you first get Pa in your lungs, you may not know you have it. But over time, you may: Develop a cough that doesn t go away Have more mucus in your lungs Feel tightness in your chest Have a hard time catching your breath Chronic lung infection with Pa is most commonly treated with inhaled antibiotics. It is important that inhaled antibiotics be taken as prescribed. There are treatments available that may be right for you. 4 Tell your doctor about all the drugs you take. Ask if you should take other medicines that may harm your nervous system, kidneys, or hearing; water pills (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol; or urea.

4 For people 6 years and older with CF, Pa, and FEV 1 25% to 80% predicted and who do not have Burkholderia cepacia TOBI Podhaler Helps Fight Pa in the Lungs of People With CF In a clinical trial versus placebo, TOBI Podhaler patients experienced: 12.44% improvement in lung function 64% reduction in percentage of hospitalizations 15% less need for intravenous (IV) antipseudomonal antibiotics TOBI Podhaler demonstrated 12.54% improvement in FEV 1 % predicted* after 28 days of treatment, compared with 0.09% improvement with placebo In another study, TOBI Podhaler did not show significant improvements in lung function compared with placebo 4.4% of patients who received TOBI Podhaler required respiratory-related hospitalizations during the course of one treatment cycle, compared with 12.2% of patients who received placebo * Lung function is measured using FEV 1, which stands for forced expiratory volume in 1 second the amount of air you can blow out in 1 second. 8.7% of patients who received TOBI Podhaler used IV antipseudomonal antibiotics during the course of one treatment cycle, compared with 10.2% of patients who received placebo It is not known if TOBI Podhaler is safe and effective when used for more than 3 cycles. Laboratory tests show reduced tobramycin activity against Pseudomonas aeruginosa bacteria in some patients with the use of TOBI Podhaler. The relationship between these lab results and how well TOBI Podhaler works is not clear. Let your health care provider know if your symptoms worsen. TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, diffi culty with balance, or dizziness. 6

5 TOBI Podhaler Delivers the Necessary Amount of Tobramycin to the Lungs as an Inhaled Dry Powder The PulmoSphere particles that make up the dry powder are: Light Uniform in size Hollow PulmoSphere particles not drawn to scale. 8 TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler.

6 TOBI Podhaler Is Designed for Patients on the Go Each TOBI Podhaler 28-day pack provides everything needed for one treatment cycle A Full Dose of TOBI Podhaler Can Be Administered in 2 to 7 Minutes 28 blister cards, each containing 8 capsules* 4 storage cases plus 1 backup mg CAPSULES TIMES A DAY DAYS ON AND PER DOSE 28 DAYS OFF 4 disposable inhalers plus 1 backup *Four capsules for inhalation in the morning and 4 capsules for inhalation in the evening. Scan with 112 mg total per dose. 10 TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby.

7 A Summary of the Instructions for Use Please see full Patient Information for complete Instructions for Use Tips to Help With TOBI Podhaler TIPS PREPARE LOAD PRESS INHALE CHECK 3x REPEAT Do not swallow TOBI Podhaler capsules For use with the Podhaler device only For oral inhalation only TOBI Podhaler capsules must not be swallowed, as the intended effects in the lungs will not be obtained Each dose of 4 capsules should be taken as close to 12 hours apart as possible; each dose should not be taken less than 6 hours apart TOBI Podhaler capsules should always be stored in the blister card; each capsule should only be removed IMMEDIATELY BEFORE USE The Podhaler device should always be stored in its case and tightly closed when not in use Watch the Instructions for Use video at TOBIPodhaler.com/Instructions. Scan with TOBI Podhaler is a non-nebulized dry powder. The inhalation technique used to administer TOBI Podhaler may be different from the technique used with other dry-powder medications. Inhaling TOBI Podhaler with the proper technique is important. Inhalation position As you prepare to inhale, tilt your head back slightly Inhalation speed Inhale with a single steady deep breath Make sure you hear the capsule spinning when inhaling If you inhale TOBI Podhaler too fast, the large amount of powder hitting the back of your throat may cause you to cough Slow down with your next inhalation If you inhale too slowly, the capsule may not be emptied in 2 inhalations If the capsule is pierced but not empty after 2 inhalations, you may need to inhale faster next time The right inhalation speed varies from person to person, and it may take some practice to find the speed that is right for you Inhaling dry powder It is possible you may cough after you inhale TOBI Podhaler, especially if you are not used to it. If you do cough: Turn your face away from the device It may help to take a sip of water Inhale more slowly with your next inhalation TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness. Scan with 12

8 TOBI Podhaler Has an Established Safety Profile Patients treated with TOBI Podhaler may experience side effects Cough may develop when taking TOBI Podhaler Most Common Side Effects TOBI Podhaler TOBI Cough may develop while taking TOBI Podhaler, especially during the first week of treatment In a clinical study, after the fi rst week of treatment, cough developed at a similar rate in patients taking TOBI Podhaler and patients taking TOBI Children and adolescents treated with TOBI Podhaler coughed more than adults coughed Cough 48.4% 31.1% Worsening of lung problems or cystic fibrosis 33.8% 30.1% Productive cough 18.2% 19.6% Shortness of breath 15.6% 12.4% Fever 15.6% 12.4% Sore throat 14.0% 10.5% Voice alteration* 13.6% 3.8% Coughing up blood 13.0% 12.4% Headache 11.4% 12.0% Altered taste 3.9% 0.5% Discontinuations due to side effects were 14% for TOBI Podhaler vs 8% for TOBI (Tobramycin Inhalation Solution, USP) 300 mg/5 ml *Majority of voice alterations recorded as hoarseness. The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness or loss of voice), coughing up blood, headache, and altered taste. Severe breathing problems were experienced in 5% of patients in both treatment groups No patients experienced cough and severe breathing problems at the same time TOBI Podhaler can cause serious side effects, including: Hearing loss or ringing in the ears: Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears such as ringing or hissing. Tell your healthcare provider if you develop vertigo, difficulty with balance or dizziness Worsening kidney problems: TOBI Podhaler is in a class of drugs which may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler Worsening muscle weakness: TOBI Podhaler is in a class of drugs which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis or Parkinson s disease) Severe breathing problems (bronchospasm): Tell your healthcare provider right away if you get any of these symptoms of bronchospasm with using TOBI Podhaler: shortness of breath with wheezing coughing and chest tightness Fetal harm: TOBI Podhaler is in a class of drugs which may cause harm to an unborn baby 14

9 INDICATION TOBI Podhaler (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fi brosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial. Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing. Tell your doctor about all the drugs you take. Ask if you should take other medicines that may harm your nervous system, kidneys, or hearing; water pills (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol; or urea. TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, diffi culty with balance, or dizziness. TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler. TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby. TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness. The most common side effects of TOBI Podhaler include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness or loss of voice), coughing up blood, headache, and altered taste. Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA

10 PodCare+ : Support Every Step of the Way to Help You Succeed Work With Your Doctor to Get TOBI Podhaler 1 2 Complete the PodCare+ Enrollment Form with your doctor Make sure you and your doctor sign all required sections Sign up for PodCare+ and you may be eligible for a $0 co-pay.* Helps you get TOBI Podhaler Confi rms your coverage and connects you with Specialty Pharmacies Offers prescription co-pay savings Helps you get started Nurses available* to answer administration questions Resources to teach you how to take TOBI Podhaler Helps you get motivated Provides ongoing support with the patient outreach program 3 Your doctor should then fax the form, along with a copy of your insurance card(s), to Download the PodCare+ Enrollment Form at TOBIPodhaler.com, or get it from your doctor s office. * The PodCare+ Hotline is available Monday through Friday, 8 AM to 8 PM ET, at TOBI (8624). Nurses are available until 7 PM. Valid for those with commercial insurance. Not valid under Medicare, Medicaid, or any other federal or state program or for cash-paying patients. Limitations apply. Novartis reserves the right to rescind, revoke, or amend the program, without notice. Patient is responsible for reporting receipt of program rewards to any private insurer that pays for or reimburses any part of prescriptions fi lled with this program. Patient pays a $0 co-pay for each use and Novartis pays up to $14,000 annually. This offer expires December 31, Scan with 18

11 Talk to Your Doctor About TOBI Podhaler Today And experience the powder of non-nebulized Pa treatment On-the-go device No disinfection No refrigeration, power source, batteries, or compressor Administered in 2 to 7 minutes Helps fight Pa In a clinical trial: Improved lung function Reduced hospitalizations Decreased need for IV antipseudomonal antibiotic use Established safety profile Studied across 3 clinical trials To learn more about TOBI Podhaler, go to TOBIPodhaler.com or find us on Facebook. INDICATION TOBI Podhaler (Tobramycin Inhalation Powder) 28 mg per capsule is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. It is not known if TOBI Podhaler is safe and effective in patients under 6 years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away. Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis Printed in USA 12/13 TBI A