Glossary

Some of the terms on this site may be unfamiliar to you. Here is a glossary for your reference.

Antibiotic [an-ti-bi-ott-ik]

A drug that kills bacteria or slows bacterial growth. Antibiotics are often used to treat lung infections.

Bacteria [bak-teer-ee-uh] (sometimes referred to as "bacterium" in the singular)

Very small, single-celled organisms that can reproduce quickly and are capable of causing an infection.

Chronic lung infection

A lung infection that lasts for a long time.

FEV1

Forced expiratory volume in 1 second (FEV1), or the amount of air you can blow out in 1 second. FEV1 is used to measure lung function.

Genetic [je-ne-tik]

Inherited from your parents through their genes.

Inhalation [in-hale-ay-shun]

The breathing in of an airborne substance that may be in the form of a gas, mist, vapor, powder, or aerosol.

Lung function [luhng fuhngk-shun]

When evaluating efficacy of TOBI Podhaler, measured by FEV1. After FEV1 is measured, it is expressed as a percentage of the predicted normal FEV1 value for the patient, or FEV1% predicted.

Mucus [myu-kus]

A slippery substance secreted by cells and glands in the mucous membrane. People with cystic fibrosis produce thicker mucus than healthy people do, which can clog their lungs.

Nebulizer [neb-u-lye-zer]

A device for creating and administering an aerosol spray.

Off-cycle

Following the on-cycle, the 28 days when you are off treatment.

On-cycle

The 28 days when you are on treatment.

Pseudomonas aeruginosa (soo-doh-MOH-nass ah-ru-ji-NOH-sa)

A type of bacteria that can cause lung infections in people with cystic fibrosis. Pa is the abbreviation.

PulmoSphere [pul-moh-sfeere]

Developed by Novartis Pharmaceuticals Corporation, PulmoSphere particles allow the necessary amount of antibiotic to be delivered in a dry-powder form.

IMPORTANT SAFETY INFORMATION

INDICATION

TOBI® Podhaler® (Tobramycin Inhalation Powder) 28 mg 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 6 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

You should not use TOBI Podhaler if you are allergic to it or to any other aminoglycoside antibacterial.

Tell your doctor before starting treatment if you have or have had hearing, kidney, breathing, or muscle weakness problems or if you have dizziness, an organ transplant, or are pregnant or nursing.

Tell your doctor about all the drugs you take. Ask if you should take other medicines that may harm your nervous system, kidneys, or hearing; "water pills" (diuretics) such as Edecrin (ethacrynic acid), Lasix (furosemide), or mannitol; or urea.

TOBI Podhaler can cause serious side effects, including hearing loss or ringing in the ears. Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.

TOBI Podhaler is in a class of drugs that may worsen kidney problems, especially in people with known or suspected kidney problems. Your health care provider may do a blood test to check how your kidneys are working while you are using TOBI Podhaler.

TOBI Podhaler is in a class of drugs that may worsen muscle weakness problems or harm an unborn baby.

TOBI Podhaler can cause severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing, or coughing and chest tightness.

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 or loss of voice), coughing up blood, headache, and altered taste.

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.