Tobi Podhaler

• Novartis Pharmaceuticals Corporation

Tobi Podhaler is part of the drug class:

• Other aminoglycosides

Serious side effects have been reported with TOBI Podhaler. See “Drug Precautions” section.

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
• headache
• altered taste

This is not a complete list of TOBI Podhaler side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines that may harm your nervous system, kidneys, or hearing
• “water pills” (diuretics) such as hydrochlorothiazide (Microzide) or furosemide (Lasix)

This is not a complete list of TOBI Podhaler drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of TOBI Podhaler, there are no specific foods that you must exclude from your diet when receiving TOBI Podhaler.

Before taking TOBI Podhaler, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had hearing problems (including noises in your ears such as ringing or hissing)
• have dizziness
• have or have had kidney problems
• have or have had problems with muscle weakness such as myasthenia gravis or Parkinson’s disease
• have or have had breathing problems such as wheezing, coughing, or chest tightness
• have had an organ transplant
• are pregnant or are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

This section provides information on the proper use of a number of products that contain tobramycin. It may not be specific to Tobi Podhaler. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Tobramycin usually comes with patient instructions. Read them carefully before using this medicine. Ask your doctor if you have any questions.

If you are using the inhalation solution:

• Tobramycin inhalation solution is packaged in small plastic containers called ampules. Each ampule contains one full dose of tobramycin. Do not use an ampule that has already been opened. Also, do not use an ampule of this medicine after the expiration date printed on the package.
• Tobramycin is especially formulated to be used with a PARI LC PLUS™ nebulizer. Tobi® is used together with a DeVilbiss® Pulmo-Aide® compressor, while Bethkis® is used together with a PARI Vios air compressor. An air compressor is used with a nebulizer to turn the medicine into a fine spray. You will breathe the spray in through your mouth and to your lungs.
• Use the mouthpiece of the nebulizer to breathe in Bethkis®.
• You will need to use the nebulizer for about 10 to 15 minutes, or until the medicine in the nebulizer cup is gone. You may hear a sputtering sound when the cup is empty.
• Clean all the parts of the nebulizer after each use.
• You may want to rinse your mouth or suck on hard candy if Tobi® inhalation solution leaves a bad taste in your mouth.

If you are using the inhalation capsule:

• Do not swallow the inhalation capsules.
• This medicine is especially formulated to be used with the Podhaler™ device.
• Store the capsules in the blister pack until you are ready to use them.
• Always use a new Podhaler™ device every 7 days.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece in your mouth with the device upright.
• Breathe in slowly and deeply.
• Hold your breath for about 5 seconds, then breathe out slowly.
• Check if the capsule is empty after inhaling. If some powder remains in the capsule, repeat inhalation until the capsule is empty.
• Wipe the mouthpiece with a clean, dry cloth. Make sure that the Podhaler™ stays dry at all times to work the right way.

If you are taking any other medicines for cystic fibrosis, keep taking them as you did before you started using tobramycin, unless otherwise directed by your doctor. However, do not put any other inhaled medicine in the nebulizer at the same time that you use tobramycin. Other inhaled medicines may be used in a clean nebulizer before or after your treatment with tobramycin. It is recommended that Tobi® Podhaler™ is taken last.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For Pseudomonas lung infections:
  • For inhalation dosage form (solution):
    • Adults, teenagers, and children 6 years of age and older—One ampule or container with 300 milligrams (mg) of tobramycin two times a day for 28 days in the nebulizer. Then, stop using this medicine and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For inhalation dosage form (capsule):
    • Adults, teenagers, and children 6 years of age and older—Four capsules with 28 milligrams (mg) of tobramycin two times a day for 28 days in the Podhaler™ device. Then, stop using this medicine and wait 28 days, and repeat the cycle (28-day on, 28-day off cycle). You should space the doses at least 6 hours apart.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If you can't keep the tobramycin inhalation solution in the refrigerator, store the medicine in the foil pouch at room temperature away from heat or direct light. Do not use the unrefrigerated medicine after 28 days.

Store the Tobi® Podhaler™ capsules at room temperature, away from heat and direct light. Keep the capsules and Podhaler™ device in a dry place.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about TOBI Podhaler, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about TOBI Podhaler. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using TOBI Podhaler (tobramycin inhalation powder).

Review Date: October 4, 2017

     Pregnancy

Teratogenic Effects – Pregnancy Category D [see Warnings and Precautions (5.6)]

No reproduction toxicology studies have been conducted with Tobi Podhaler. However, subcutaneous administration of tobramycin at doses of 100 or 20 mg/kg/day during organogenesis was not teratogenic in rats or rabbits, respectively. Doses of tobramycin ≥40 mg/kg/day were severely maternally toxic to rabbits and precluded the evaluation of teratogenicity. Ototoxicity was not evaluated in offspring during nonclinical reproduction toxicity studies with tobramycin.

Aminoglycosides can cause fetal harm (e.g., congenital deafness) when administered to a pregnant woman. No adequate and well-controlled studies of Tobi Podhaler in pregnant women have been conducted. If Tobi Podhaler is used during pregnancy, or if the patient becomes pregnant while taking Tobi Podhaler, the patient should be apprised of the potential hazard to the fetus.

     Nursing Mothers

The amount of tobramycin excreted in human breast milk after administration by inhalation is not known. Because of the potential for ototoxicity and nephrotoxicity in infants, a decision should be made whether to terminate nursing or discontinue the drug, taking into account the importance of the drug to the mother.

     Pediatric Use

Patients 6 years and older were included in the Phase 3 studies with Tobi Podhaler; 206 patients below 20 years of age received Tobi Podhaler. No dosage adjustments are needed based on age. The overall pattern of adverse events in pediatric patients was similar to the adults. Dysgeusia (taste disturbance) was more commonly reported in younger patients six to 19 years of age than in patients 20 years and older, 7.4% versus 2.7%, respectively. Safety and effectiveness in pediatric patients below the age of 6 years have not been established.

     Geriatric Use

Clinical studies of Tobi Podhaler did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Tobramycin is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function [see Warnings and Precautions (5.2, 5.5)].

     Renal Impairment

Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin. The risk of adverse reactions to this drug may be greater in patients with impaired renal function. Patients with serum creatinine ≥2 mg/dL and blood urea nitrogen (BUN) ≥40 mg/dL have not been included in clinical studies and there are no data in this population to support a recommendation regarding dose adjustment with Tobi Podhaler [see Warnings and Precautions (5.2, 5.5)].

     Hepatic Impairment

No studies have been performed in patients with hepatic impairment. As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected.

     Organ Transplantation

Adequate data do not exist for the use of Tobi Podhaler in patients after organ transplantation.