Learn how TOBI PODHALER may fit into your patient’s day
Patients and caregivers should be initially trained by their CF Care Team on the proper use of TOBI PODHALER
Patients and caregivers should be initially trained by their CF Care Team on the proper use of TOBI PODHALER
*Average time as observed in a randomized, open-label, active controlled study to evaluate safety.
The following is intended to provide general information for prescribing TOBI PODHALER for medically appropriate patients. Each CF center remains responsible for properly submitting all information for their patients.†
When prescribing TOBI PODHALER for a patient for the first time, be sure to note the following information:
Make the most of TOBI PODHALER (Tobramycin Inhalation Powder) 28 mg per capsule by watching our step-by-step video showing how to use the device properly.
TOBI® PODHALER® (Tobramycin Inhalation Powder), 28 milligrams 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 six 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. Stay tuned for additional Important Safety Information in this video.
Welcome to the TOBI PODHALER Instructions for Use video. My name is Catherine Richards and I'm a respiratory therapist. It is important to learn how to correctly take TOBI PODHALER.
Each TOBI PODHALER package contains a 28 days supply or 4 weekly packs. A weekly pack contains 7 blister cards of eight capsules. 4 capsules are used for inhalation in the morning and 4 capsules are used for inhalation in the evening. Each weekly pack also comes with one podhaler device and its storage case. One extra podhaler device and its storage case are also included, if something should happen to any of the other weekly devices.
Please note the following.
Do not swallow TOBI PODHALER capsules. The powder in the capsule is for you to inhale using the podhaler device. Only use the podhaler device contained in this pack. Do not use TOBI PODHALER capsules with any other device and do not use the TOBI PODHALER device to take any other medicine. When you start a new weekly seven-day pack of capsules, use the new podhaler device that is supplied in the weekly pack and then discard the use device and its case.
Each podhaler device is only used for one week (seven days). Always keep the TOBI PODHALER capsules in the blister card.
Remove one capsule at a time just before you're going to use it. Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart. Once in a while, very small pieces of the capsules can get into your mouth and you may be able to feel these pieces on your tongue.
These small pieces will not hurt you if you swallow or inhale them. The extra podhaler device provided in the package may be used if the podhaler device is wet, dirty or broken, has been dropped, or does not seem to be piercing the capsule properly.
Now Sarah will walk you through the next steps.
Hi, my name is Sarah and I'll be your TOBI PODHALER guide. Now you can prepare to take TOBI PODHALER.
First, you must wash and dry your hands completely.
Just before use, hold the base of the podhaler device and unscrew the lid in a counter-clockwise direction. Then set the lid aside. Hold onto the body of the podhaler device and unscrew the mouthpiece in a counter-clockwise direction. Stand the podhaler device upright in the base of the case. Then set the mouthpiece aside on a clean, dry surface. Now you can load the device.
Take one blister card and tear the pre-cut lines along the length first and then tear along the width. Peel back the foil that covers one TOBI PODHALER capsule on the blister card and remove one capsule. Only remove one capsule at a time just before you are going to use it in the podhaler device. Always hold the foil close to where you are peeling. Immediately place the TOBI PODHALER capsule in the capsule chamber at the top of the podhaler device.
Do not put the capsule directly into the top of the mouthpiece. Put the mouthpiece back on your podhaler device and screw it in a clockwise direction until it is tight. Do not over tighten.
Holding the podhaler device with the mouthpiece pointing down, press the blue button all the way down with your thumb and then let go. Do not press the blue button more than once. Now it is time to inhale. You will need to inhale at least twice from each capsule in order to get the full dose.
First, breathe out all the way. Do not blow or exhale into the mouthpiece. Place your mouth over the mouthpiece and close your lips tightly around it. Inhale deeply with a single breath.
After you inhale, remove the podhaler device from your mouth. Hold your breath for about 5 seconds, then exhale normally away from the podhaler device.
Take a few normal breaths away from the podhaler device. Do not blow or exhale into the mouthpiece.
For your second inhalation, repeat the inhalation steps using the same capsule. When you have finished, unscrew the mouthpiece, and remove the TOBI PODHALER capsule from the capsule chamber. Now you can check to make sure you have inhaled the powder correctly.
Look at the used capsule. It should be pierced and empty except for a fine coating of powder remaining on the inside of the capsule.
If it is pierced and empty, throw it away. If the capsule is pierced but still contains more than just a fine coating of powder, put the capsule back into the podhaler device capsule chamber with the pierced side of the capsule pointing down. Put the mouthpiece back on and inhale following the same inhalation steps. If the capsule does not look pierced, put it back into the podhaler device capsule chamber. Put the mouthpiece back on, press the blue button and inhale following the same inhalation steps.
If the capsule still does not look pierced and still has some powder in it, use the extra podhaler device to take the medication.
Repeat three more times until your whole dose has been taken. Remember, 1 dose of TOBI PODHALER includes 4 capsules. After you finish your TOBI PODHALER dose, throw away all the empty TOBI PODHALER capsules and screw the mouthpiece back onto the podhaler device. Do not over tighten. Do not store the TOBI PODHALER capsules in the device. Wipe the mouthpiece with a clean dry cloth. Do not wash the podhaler device with water. Your podhaler device needs to stay dry at all times to work the right way.
Now Catherine will guide you through some further instructions for use.
Thank you, Sarah.
Now place your podhaler device back in the storage case base. Place the lid back on the storage case base and screw the cover in a clockwise direction until it is tight. You have now completed a single dose of TOBI PODHALER.
Store your podhaler device and blister package capsules at room temperature between 68° Fahrenheit to 77° Fahrenheit or 20° Celsius to 25° Celsius. Keep the TOBI PODHALER capsules and Podhaler device in a dry place.
Store the podhaler device tightly closed in its case when you are not using it. Keep TOBI PODHALER capsules, the podhaler device and all medicines out of the reach of children.Please refer to the full prescribing information for additional information. Thank you for watching the TOBI PODHALER instructions for use video.
We hope that you will review these instructions and learn to correctly use TOBI PODHALER to help you stay on track and make the most of your treatment experience.
TOBIPODHALER(Tobramycin Inhalation Powder), 28 milligram 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 six years of age, in those with lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia.
IMPORTANT SAFETY INFORMATION.
Do not swallow TOBI PODHALER capsules. TOBI PODHALER capsules are used only with the podhaler device and inhaled through your mouth or oral inhalation. Never place a capsule in the mouthpiece of the podhaler device.
You should not use TOBI PODHALER if you are allergic to it or to any other aminoglycoside antibacterial medicines. Tell your doctor before starting treatment all of your medical conditions, including if you have or have had hearing problems, dizziness, kidney problems, muscle weakness, breathing problems such as wheezing, coughing, or chest tightness if you had an organ transplant, are pregnant or nursing, or plan to become pregnant or nurse.
TOBI PODHALER contains a medicine that can harm your unborn baby. It is not known if it passes into breast milk. Check your baby for watery stools, bloody stools, thrush or diaper rash if you breastfeed.
Tell your doctor about all the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements. If you are using TOBI PODHALER, discuss if you should take other medicines that may harm your nervous system, kidneys, or hearing; “water pills” or diuretics such as Edecrinor ethacrynic acid, Lasixor furosemide, or intravenous mannitol; urea.
TOBI PODHALER can cause serious side effects, including:
Severe breathing problems (bronchospasm).Tell your doctor right away if you get shortness of breath with wheezing or coughing and chest tightness while using TOBI PODHALER.
Hearing loss or ringing in the ears (ototoxicity). Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, dizziness, or your mother has had hearing problems after taking an aminoglycoside. Tell your doctor if you have been told you have certain gene variants, a change in the gene related to hearing abnormalities inherited from your mother.
Worsening kidney problems, or nephrotoxicity. TOBI PODHALER is in a class of medicines that 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 medicines that can cause worsening muscle weakness in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease).
TOBI PODHALER is in a class of medicines which may cause harm to an unborn baby. 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, coughing up blood and headache.
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 www.fda.gov/medwatch or call 1-800-FDA -1088.
TOBI® PODHALER® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.
TOBI PODHALER is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Bronchospasm can occur with inhalation of TOBI PODHALER. Bronchospasm should be treated as medically appropriate.
Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.
Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI PODHALER clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness.
Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI PODHALER clinical studies but has been associated with aminoglycosides as a class.
TOBI PODHALER should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI PODHALER during pregnancy, or who become pregnant while taking TOBI PODHALER, should be apprised of the potential hazard to the fetus. The amount of tobramycin excreted in human breast milk is unknown. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal. A decision should be made whether to discontinue nursing or TOBI PODHALER. TOBI may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis.
Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.
Concurrent and/or sequential use of TOBI PODHALER with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI PODHALER should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.
In a clinical trial, the most commonly observed adverse events with TOBI PODHALER occurring at a frequency of at least 10%, were cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache.
Please see Full Prescribing Information