TOBI is inhaled, which means you breathe TOBI in through your mouth.
The right way to take TOBI® (Tobramycin Inhalation Solution, USP)
is by using a special pump called a compressor
and a
breathing device called a nebulizer
.
TOBI should be taken using only the PARI LC® PLUS Reusable Nebulizer
and DeVilbiss® Pulmo-Aide® air compressor
TOBI should never be diluted or mixed in the nebulizer with any other medications, including dornase alfa
Make sure to finish the whole dose of TOBI. Don’t leave any in the nebulizer
TOBI is a liquid that comes in a plastic vial called an ampule
.
Each foil pouch contains 4 ampules, for 2 days of TOBI therapy. These ampules are ready to use. Each ampule of TOBI contains 300 mg of tobramycin
in a 5-mL solution
TOBI ampules should be stored in the refrigerator (2-8°C or 36-46°F). However, if you’re transporting TOBI or if there’s no refrigerator available, you can store the foil pouches of TOBI (opened or unopened) for up to 28 days at room temperature not exceeding 25°C or 77°F
When TOBI is not refrigerated, it may darken with age. But the color change does not indicate any change in the quality of the product
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 expose TOBI to intense light
Do not use TOBI beyond the expiration date stamped on the ampule
Information for Patients and Caregivers
TOBI® (Tobramycin Inhalation Solution, USP) is a prescription inhaled medication for cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. TOBI has not been studied in patients under 6 years of age, in those with a lung function outside of a certain range, or in those whose lungs contain bacteria called Burkholderia cepacia. Ask your doctor if TOBI is right for you.
IMPORTANT SAFETY INFORMATION
If you are allergic to antibiotics in the same family as TOBI (ie, aminoglycosides), you should not take TOBI. Tell your doctor before starting treatment if you have any history of hearing, kidney, balance, or muscle problems.
Patients taking TOBI may have temporary side effects like coughing or difficulty breathing.
Some people taking TOBI experienced ringing in the ears, hearing loss, or changes in
voice (hoarseness)
.
Ringing in the ears may be a warning sign for hearing loss. If you
have ringing in the ears, changes in hearing, or dizziness, you should tell your doctor.
In studies, kidney damage was not seen in patients taking TOBI. However, antibiotics in the same family as TOBI have been linked to kidney damage.
If you are pregnant, plan to become pregnant, or if you are breast-feeding, talk with your doctor before taking TOBI.
Some drugs may interact with TOBI. Discuss all medications you are taking with your doctor.
Patients with cystic fibrosis can have many symptoms. Some of these may be related to your medications. You should tell your doctor if you have new or worsening symptoms.
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.
