Patient information: uses, side effects, how to take - Tobi

What is TOBI?

TOBI is a prescription medicine that is used to treat people with cystic fibrosis who have a bacterial infection called Pseudomonas aeruginosa. TOBI contains an antibacterial medicine called tobramycin (an aminoglycoside).

It is not known if TOBI is safe and effective:

in children under 6 years of age
in people who have an FEV₁less than 25% or greater than 75% predicted
in people who are colonized with a bacterium called Burkholderia cepacia

Do not take TOBI if you are allergic to tobramycin, any of the ingredients in TOBI, or to any other aminoglycoside antibacterial.

See the end of this Patient Information for a complete list of ingredients in TOBI.

Before you take TOBI, tell your healthcare provider about all of your medical conditions, including if you:

have or have had hearing problems (including noises in your ears such as ringing or hissing), hearing loss, or your mother has had hearing problems after taking an aminoglycoside.
have been told you have certain gene variants (a change in the gene) related to hearing abnormalities inherited from your mother.
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
are pregnant or plan to become pregnant. TOBI is in a class of drugs that can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if TOBI passes into your breast milk.
are receiving aminoglycoside therapy by injection or through a vein (intravenous) while taking TOBI. Your blood levels of tobramycin will be checked.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take TOBI?

See the step-by-step Instructions for Use about the right way to take your TOBI.
Take TOBI exactly as your healthcare provider tells you. Do not change your dose or stop taking TOBI unless your healthcare provider tells you to.
The usual dose for adults and children over 6 years of age is:
- 1 single-use ampule of TOBI inhaled 2 times each day using a hand-held PARI LC PLUS^™Reusable Nebulizer and a DeVilbiss^®Pulmo-Aide^®air compressor.
Each dose of TOBI should be taken as close to 12 hours apart as possible.
You should not take your dose less than 6 hours apart.
TOBI is taken as a breathing treatment (inhalation) with a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. Do not use any other nebulizer for your TOBI treatment.
Do not mix or dilute TOBI with dornase alfa or other medicines in your nebulizer system.
Each treatment should take about 15 minutes.
TOBI should be inhaled while you are sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help you to breathe through your mouth.
If you forget to take TOBI and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose.
After using TOBI for 28 days, you should stop using it and wait 28 days. After you have stopped using TOBI for 28 days, you should start using TOBI again for 28 days. Complete the full 28-day course even if you are feeling better. It is important that you keep to the 28-day on, 28-day off cycle.

If you are taking several medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments before inhaling TOBI or as directed by your healthcare provider. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter prescription medicines, vitamins, and herbal supplements.

Using TOBI with certain other medicines can cause serious side effects.

If you are using TOBI, you should discuss with your healthcare provider if you should take:

other medicines that may harm your nervous system, kidneys, or hearing
“water pills” (diuretics) such as ethacrynic acid, furosemide, or intravenous mannitol
urea

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

What are the possible side effects of TOBI?

TOBI may cause serious side effects, including:

severe breathing problems (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm with using TOBI:
- shortness of breath with wheezing
- coughing and chest tightness
hearing loss or ringing in the ears (ototoxicity). 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 (nephrotoxicity). TOBI 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.
worsening muscle weakness (neuromuscular disorder). TOBI 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).

The most common side effects of TOBI include:

increased cough
coughing up blood
voice changes

sore throat
decreased lung function
loss or change in taste

increased sputum
trouble breathing
rash

These are not all of the possible side effects of TOBI.

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

General information about the safe and effective use of TOBI

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TOBI for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for more information about TOBI that is written for health professionals.

What are the ingredients in TOBI?

Active ingredient: tobramycin

Inactive ingredients: sodium chloride in sterile water for injection, sulfuric acid, sodium hydroxide, and nitrogen

What is Pseudomonas aeruginosa?

It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing.

Distributed by:

Viatris Specialty LLC

Morgantown, WV 26505 U.S.A.

TOBI is a registered trademark of BGP Products Operations GmbH, a Viatris Company.

The brands listed are trademarks of their respective owners.

For more information, call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 11/2025

VSL:CB:PIL:TOBRIS:R1

Instructions for Use

TOBI (TOH-bee)

(tobramycin inhalation solution)

for oral inhalation use

Read this Instructions for Use before you start using TOBI inhalation solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

TOBI is made for inhalation using a PARI LC PLUS™ Reusable Nebulizer and a DeVilbiss® Pulmo-Aide® air compressor. TOBI can be taken at home, school, or at work. The following instructions tell you how to use the DeVilbiss Pulmo-Aide air compressor and PARI LC PLUS Reusable Nebulizer to administer TOBI.

You will need the following supplies (See Figure A):

1 TOBI plastic ampule (TOBI is packaged with either 4 or 14 ampules in each foil pouch)
DeVilbiss Pulmo-Aide air compressor
PARI LC PLUS Reusable Nebulizer
Tubing to connect the nebulizer and compressor
Clean paper or cloth towels
Nose clips (optional)

(Figure A)

It is important that your nebulizer and compressor function properly before starting your TOBI therapy.

Note: Read the manufacturer care and use instructions for important information.

Prepare Your TOBI for Inhalation Therapy

Step 1: Wash your hands thoroughly with soap and water.

Step 2: Open the foil pouch.

Step 3: Separate 1 TOBI ampule by gently pulling apart at the bottom tabs (See Figure B). Place the remaining TOBI ampules in the refrigerator.

(Figure B)

Step 4: Check the expiration date stamped on the TOBI ampule (See Figure C). Do not use the TOBI ampule if the expiration date has passed.

(Figure C)

Step 5: Check that the TOBI ampule medicine is clear and does not have particles.

Unrefrigerated TOBI, which is normally slightly yellow, may darken with age. This color change does not mean there is any change in the quality of the medicine.
Do not use the TOBI ampule if the medicine is cloudy or has particles.
Throw it away and get a new one.

Step 6: Lay out the parts of a PARI LC PLUS Reusable Nebulizer package on a clean, dry paper or cloth towel. You should have the following parts (See Figure D):

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

(Figure D)

Step 7: Remove the Nebulizer Top from the Nebulizer Cup by twisting the Nebulizer Top counter-clockwise, and then lifting off (See Figure E).

(Figure E)

Step 8: Place the Nebulizer Top on the clean paper or cloth towel by standing the Nebulizer Cup upright on the towel (See Figure F).

(Figure F)

Step 9: Connect one end of the tubing to the compressor air outlet (See Figure G). The tubing should fit tightly.

(Figure G)

Step 10: Plug in your compressor to an electrical outlet (See Figure H).

(Figure H)

Step 11: Open the TOBI ampule by holding the bottom tab with 1 hand and twisting off the top of the TOBI ampule with the other hand (See Figure I). Be careful not to squeeze the TOBI ampule until you are ready to empty all the medicine into the Nebulizer Cup.

(Figure I)

Step 12: Squeeze all the medicine of the TOBI ampule into the Nebulizer Cup (See Figure J).

(Figure J)

Step 13: Replace the Nebulizer Top. To replace the Nebulizer Top insert the Nebulizer Top into the Nebulizer Cup with the semi-circle halfway down the stem of the Nebulizer Top facing the Nebulizer Outlet. Turn the Nebulizer Top clockwise until securely fastened to the nebulizer Cup. (See Figure K).

(Figure K)

Step 14: Push the Mouthpiece straight onto the Nebulizer Outlet (See Figure L).

(Figure L)

Step 15: Firmly push the Inspiratory Valve Cap straight down onto the Nebulizer Top (See Figure M). The Inspiratory Valve Cap will fit tightly.

(Figure M)

Step 16: Hold the Nebulizer Cup upright and firmly push the free end of the tubing from the compressor to the Air Intake on the bottom of the Nebulizer Cup (See Figure N). Make sure to keep the Nebulizer Cup upright.

(Figure N)

Giving your TOBI Inhalation Therapy

Step 17: Turn on the compressor (See Figure O).

(Figure O)

Step 18: Check for a steady mist from the Mouthpiece (See Figure P). If there is no mist, check all tubing connections and make sure that the compressor is working properly.

(Figure P)

Step 19: Sit or stand in an upright position that will allow you to breathe normally. Place the Mouthpiece between your teeth and on top of your tongue and breathe normally only through your mouth (See Figure Q). Nose clips may help you breathe through your mouth and not through your nose. Do not block the airflow with your tongue.

(Figure Q)

Step 20: Keep breathing in your TOBI medicine for at least 15 minutes to get your full dose. Continue therapy until all your TOBI medicine is gone, and there is no longer any mist being made. You may hear a sputtering sound coming from the Mouthpiece when the Nebulizer Cup is empty. The entire TOBI therapy should take about 15 minutes to complete.

If you are interrupted, need to cough or rest during your TOBI treatment, turn off the compressor to save your medicine. Turn the compressor back on when you are ready to restart your treatment.

Follow the nebulizer cleaning and disinfecting instructions after completing your therapy.

After your TOBI Inhalation Therapy

Cleaning Your Nebulizer

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 made, and your therapy will not be as effective. Replace the nebulizer if clogging occurs.

1) Remove tubing from nebulizer and disassemble nebulizer parts.
2) Wash all parts (except tubing) with warm water and liquid dish soap.
3) Rinse thoroughly with warm water and shake out water.
4) Air dry or hand dry nebulizer parts on a clean, lint-free cloth. Reassemble nebulizer when dry, and store.

You can also wash all parts of the nebulizer in a dishwasher (except tubing).

1) Place the nebulizer parts in a dishwasher basket.
2) Place the dishwasher basket on the top rack of the dishwasher.
3) 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 disinfect the nebulizer every other treatment day. Failure to disinfect the nebulizer every other treatment day 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

Follow the manufacturer instructions for care and use of your compressor.

Filter Change:

DeVilbiss Compressor filters should be changed every 6 months or sooner if the filter turns completely gray in color.

Compressor Cleaning:

With power switch in the “Off” position, unplug power cord from wall outlet.
Wipe outside of the compressor cabinet with a clean, damp cloth every few days to keep dust free.

Caution: Do not submerge in water because this will damage the compressor.

How should I store TOBI?

Store TOBI ampules in a refrigerator between 36°F to 46°F (2°C to 8°C) until needed.
You may store the TOBI ampules in the foil pouches (opened or unopened) at room temperature 77°F (25°C) for up to 28 days.
Do not use TOBI ampules if they have been stored at room temperature for more than 28 days.
Protect TOBI ampules from light.

Keep TOBI and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Additional Information

Nebulizer: 1-800-327-8632

Compressor: 1-800-338-1988

TOBI: Call Viatris at 1-877-446-3679 (1-877-4-INFO-RX).