Tobi

Tobi is a prescription medication used to treat lung infections caused by certain bacteria in patients over 6 years old with long-standing cystic fibrosis. Tobi belongs to a group of medicines called aminoglycoside antibiotics. These work to treat infections by inhibiting critical life-sustaining processes within bacteria which causes the bacteria to die.

This medication comes in single-use ampules to be administered through inhalation with the use of a nebulizer machine, typically twice per day.

Common side effects of Tobi include cough, irritation of the nose and/or throat, and lack of energy.

This medication may also cause dizziness. Do not drive or operate heavy machinery until you know how Tobi affects you.

Tobi is a prescription medication used to treat lung infections caused by the bacteria P. aeruginosa in patients over 6 years old with long-standing cystic fibrosis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Tobi. See the “Tobi Precautions” section.

Common side effects of Tobi include the following:

• cough
• irritation of the nose and/or throat
• lack of energy
• difficulty breathing
• fever
• headache
• lack of appetite
• nausea
• weight loss

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

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:

• abobotulinum toxin A
• acetaminophen
• adefovir
• alendronate
• aluminum hydroxide
• amikacin
• amoxicillin
• amphotericin b
• ampicillin
• aspirin
• atracurium
• avibactam / ceftazidime
• bacitracin
• balsalazide
• benzoic acid
• botulinum toxin type b
• botulism immune globulin
• bromfenac
• bumetanide
• caffeine
• calcium carbonate
• capreomycin
• carboplatin
• cefamandole
• cefazolin
• cefepime
• cefixime
• cefmetazole
• cefonicid
• cefoperazone
• cefotaxime
• cefotetan
• cefoxitin
• ceftaroline
• ceftazidime
• ceftizoxime
• ceftolozane / tazobactam
• ceftriaxone
• cefuroxime
• celecoxib
• cephalothin
• cephapirin
• chlorpheniramine
• cholecalciferol
• choline salicylate
• cidofovir
• cisatracurium
• cisplatin
• clavulanate / ticarcillin
• clofarabine
• cobicistat
• colistimethate
• colistin sulfate
• cyclosporine
• cytomegalovirus immune globulin
• daptomycin
• deferasirox
• desogestrel
• dexamethasone
• dexlansoprazole
• diclofenac
• diflunisal
• diphenhydramine
• doxacurium
• drospirenone
• efavirenz
• emtricitabine
• enflurane
• entecavir
• epinephrine
• esomeprazole
• ethacrynic acid
• ethinyl estradiol
• etidronate
• etodolac
• exenatide
• famotidine
• fenoprofen
• flucytosine
• fluocinolone
• flurbiprofen
• foscarnet
• furosemide
• gallium nitrate
• gentamicin
• gentamicin topical
• hydrocodone
• hyoscyamine
• ibandronate
• ibuprofen
• ifosfamide
• immune globulin
• incobotulinumtoxinA
• indium oxyquinoline in-111
• indomethacin
• insulin inhalation, rapid acting
• kanamycin
• ketoprofen
• ketorolac
• lansoprazole
• lidocaine
• magnesium salicylate
• magnesium sulfate
• mannitol
• meclofenamate
• mefenamic acid
• meloxicam
• mesalamine
• mestranol
• methylprednisolone
• metocurine
• mezlocillin
• mivacurium
• mycophenolate mofetil
• mycophenolic acid
• nabumetone
• naproxen
• neomycin
• netilmicin
• nimodipine
• olsalazine
• omeprazole
• onabotulinumtoxinA
• oxaliplatin
• oxaprozin
• pamidronate
• pancuronium
• pantoprazole
• pemetrexed
• phenylbutazone
• pipecuronium
• piperacillin
• piroxicam
• polymyxin b
• rabeprazole
• rapacuronium
• respiratory syncytial virus immune globulin
• risedronate
• rocuronium
• rofecoxib
• salsalate
• sirolimus
• sodium salicylate
• sodium thiosalicylate
• streptomycin
• succinylcholine
• sulfasalazine
• sulindac
• tacrolimus
• telbivudine
• tenofovir
• ticarcillin
• tiludronate
• tolmetin
• torsemide
• tubocurarine
• typhoid vaccine, live
• valacyclovir
• valdecoxib
• vancomycin
• vecuronium
• zoledronic acid

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

Serious side effects have been reported with Tobi including the following: 

• Hearing loss. Consult with your physician immediately if you experience ringing in your ears while using Tobi, as this can mean your ears are being damaged and may lead to hearing loss.
• Kidney toxicity. Consult with your physician before using Tobi if you have existing kidney disease, as this medication can damage the kidneys.
• Muscle disorders. Consult with your physician before using Tobi if you have any existing neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, as medications like Tobi can aggravate these conditions.
• Difficulty breathing. Discontinue use immediately and seek medical attention if you experience persistent difficulty breathing while using Tobi.

Do not take Tobi if you:

• are allergic to Tobi or to any of its ingredients 

This medication may also cause dizziness. Do not drive or operate heavy machinery until you know how Tobi affects you.

Medications 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, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Tobi or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have existing kidney disease
• have any existing neuromuscular disorders, such as myasthenia gravis or Parkinson's disease
• have any breathing disorders including asthma or COPD
• have any hearing disorders

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tobi falls into category D. It has been shown that use of Tobi in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Tobi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Tobi.

Take Tobi exactly as prescribed.

This medication comes in single-use ampules to be administered through inhalation with the use of a nebulizer machine, typically twice per day. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.

Your physician and/or pharmacist will instruct you on proper use of your nebulizer machine and always follow their instructions exactly. For additional information on usage of Tobi, you may refer to the following sections:

Preparing Your Tobi for Inhalation

1. Wash your hands thoroughly with soap and water
2. Tobi is packaged with 4 ampules per foil pouch. Separate one ampule by gently pulling apart at the bottom tabs. Store all remaining ampules in the refrigerator as directed
3. Lay out the contents of the PARI LC PLUS Reusable Nebulizer package on a clean, dry paper or cloth towel. You should have the following parts: 

• Nebulizer Top and Bottom (Nebulizer Cup) Assembly
• Inspiratory Valve Cap
• Mouthpiece with Valve
• Tubing

Assembling the nebulizer

1. Remove the Nebulizer Top from the Nebulizer Cup by twisting the Nebulizer Top counter-clockwise, and then lifting off. Place the Nebulizer Top on the clean paper or cloth towel. Stand the Nebulizer Cup upright on the towel
2. Connect one end of the tubing to the compressor air outlet. The tubing should fit snugly. Plug in your compressor to an electrical outlet
3. Open the Tobi ampule by holding the bottom tab with one hand and twisting off the top of the ampule with the other hand. Be careful not to squeeze the ampule until you are ready to empty its contents into the Nebulizer Cup
4. Squeeze all the contents of the ampule into the Nebulizer Cup
5. Replace the Nebulizer Top. Note: In order to insert the Nebulizer Top into the Nebulizer Cup, the semi-circle halfway down the stem of the Nebulizer Top should face the Nebulizer Outlet
6. Attach the Mouthpiece to the Nebulizer Outlet. Then firmly push the Inspiratory Valve Cap in place on the Nebulizer Top. Note: The Inspiratory Valve Cap will fit snugly
7. Connect the free end of the tubing from the compressor to the Air Intake on the bottom of the nebulizer, making sure to keep the nebulizer upright. Press the tubing on the Air Intake firmly

Tobi Treatment

1. Turn on the compressor
2. Check for a steady mist from the Mouthpiece. If there is no mist, check all tubing connections and confirm that the compressor is working properly
3. Sit or stand in an upright position that will allow you to breathe normally
4. Place Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth. Nose clips may help you breathe through your mouth and not through your nose. Do not block airflow with your tongue
5. Continue treatment until all your Tobi is gone, and there is no longer any mist being produced. You may hear a sputtering sound when the Nebulizer Cup is empty. The entire Tobi treatment should take approximately 15 minutes to complete. Note: If you are interrupted, need to cough or rest during your Tobi treatment, turn off the compressor to save your medication. Turn the compressor back on when you are ready to resume your therapy
6. Follow the nebulizer cleaning and disinfecting instructions after completing therapy

Cleaning Your Nebulizer

1. To reduce the risk of infection, illness or injury from contamination, you must thoroughly clean all parts of the nebulizer as instructed after each treatment. Never use a nebulizer with a clogged nozzle. If the nozzle is clogged, no aerosol mist is produced, which will alter the effectiveness of the treatment. Replace the nebulizer if clogging occurs
2. Remove tubing from nebulizer and disassemble nebulizer parts
3. Wash all parts (except tubing) with warm water and liquid dish soap
4. Rinse thoroughly with warm water and shake out water
5. Air dry or hand dry nebulizer parts on a clean, lint-free cloth. Reassemble nebulizer when dry, and store
6. You can also wash all parts of the nebulizer in a dishwasher (except tubing). Place the nebulizer parts in a dishwasher basket, then place on the top rack of the dishwasher. Remove and dry the parts when the cycle is complete

Disinfecting Your Nebulizer

• Your nebulizer is for your use only - Do not share your nebulizer with other people. You must regularly disinfect the nebulizer. Failure to do so could lead to serious or fatal illness
• Clean the nebulizer as described above. Every other treatment day, disinfect the nebulizer parts (except tubing) by boiling them in water for a full 10 minutes. Dry parts on a clean, lint-free cloth

Care and Use of Your Pulmo-Aide Compressor

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Tobi for the treatment of lung infections caused by the bacteria P. aeruginosa in patients over 6 years old with long-standing cystic fibrosis is 300 mg administered through a nebulizer twice per day for 28 days.

If you take too much Tobi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Tobi ampules in a refrigerator (2°C–8°C or 36°F –46°F)
• Foil pouches (opened or unopened) may be stored at at room temperature (up to 25°C/77°F) for up to 28 days
• Avoid exposing Tobi ampules to intense light
• Do not use Tobi if it is cloudy, if there are particles in the solution, or if it has been stored at room temperature for more than 28 days
• Do not use Tobi beyond the expiration date stamped on the ampule
• Keep this and all medicines out of the reach of children