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Description of product
TOBI®
(tobramycin) Inhalation Solution
Nebulizer Solution – For Inhalation Use Only
DESCRIPTION
TOBI® is a tobramycin solution for inhalation. It is a sterile, clear, slightly yellow, non-pyrogenic, aqueous solution with the pH and salinity adjusted specifically for administration by a compressed air driven reusable nebulizer. The chemical formula for tobramycin is C18H37N5O9 and the molecular weight is 467.52. Tobramycin is O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxy-L-streptamine. The structural formula for tobramycin is:
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Each single-use 5 mL ampule contains 300 mg tobramycin and 11.25 mg sodium chloride in sterile water for injection. Sulfuric acid and sodium hydroxide are added to adjust the pH to 6.0. Nitrogen is used for sparging. All ingredients meet USP requirements. The formulation contains no preservatives.
INDICATIONS
TOBI is indicated for the management of cystic fibrosis patients with P. aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) < 25% or > 75% predicted, or patients colonized with Burkholderia cepacia (see Clinical Studies).
DOSAGE AND ADMINISTRATION
The recommended dosage for both adults and pediatric patients 6 years of age and older is 1 single-use ampule (300 mg) administered BID for 28 days. Dosage is not adjusted by weight. All patients should be administered 300 mg BID. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart.
TOBI is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebulizer. Nose clips may help the patient breathe through the mouth.
TOBI is administered BID in alternating periods of 28 days. After 28 days of therapy, patients should stop TOBI therapy for the next 28 days, and then resume therapy for the next 28 day on/28 day off cycle.
TOBI is supplied as a single-use ampule and is administered by inhalation, using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. TOBI is not for subcutaneous, intravenous or intrathecal administration.
Usage
TOBI is administered by inhalation over an approximately 15-minute period, using a hand-held PARI LC PLUS Reusable Nebulizer with a DeVilbiss Pulmo-Aide compressor. TOBI should not be diluted or mixed with dornase alfa (PULMOZYME, Genentech) or other medications in the nebulizer.
During clinical studies, patients on multiple therapies were instructed to take them first, followed by TOBI.
HOW SUPPLIED
TOBI 300 mg is available as follows:
NDC 0078-0494-71 5 mL single-dose ampule (carton of 56)
Storage
TOBI should be stored under refrigeration at 2°C–8°C/36°F–46°F. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI® pouches (opened or unopened) may be stored at room temperature (up to 25°C/77°F) for up to 28 days. TOBI® should not be used beyond the expiration date stamped on the ampule when stored under refrigeration (2°C–8°C/36°F–46°F) or beyond 28 days when stored at room temperature (25°C/77°F).
TOBI ampules should not be exposed to intense light. The solution in the ampule is slightly yellow, but may darken with age if not stored in the refrigerator; however, the color change does not indicate any change in the quality of the product as long as it is stored within the recommended storage conditions.
SIDE EFFECTS
TOBI was generally well tolerated during two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received TOBI in alternating periods of 28 days on and 28 days off drug in addition to their standard cystic fibrosis therapy for a total of 24 weeks.
Voice alteration and tinnitus were the only adverse experiences reported by significantly more TOBI-treated patients. Thirty-three patients (13%) treated with TOBI complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
Eight patients from the TOBI group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the TOBI treatment regimen, and were not associated with loss of hearing in audiograms. Tinnitus is one of the sentinel symptoms of cochlear toxicity, and patients with this symptom should be carefully monitored for high frequency hearing loss. The numbers of patients reporting vestibular adverse experiences such as dizziness were similar in the TOBI and placebo groups.
Nine (3%) patients in the TOBI group and nine (3%) patients in the placebo group had increases in serum creatinine of at least 50% over baseline. In all nine patients in the TOBI group, creatinine decreased at the next visit.
DRUG INTERACTIONS
In clinical studies of TOBI, patients taking TOBI concomitantly with dornase alfa (PULMOZYME, Genentech), ß-agonists, inhaled corticosteroids, other anti-pseudomonal antibiotics, or parenteral aminoglycosides demonstrated adverse experience profiles similar to the study population as a whole.
Concurrent and/or sequential use of TOBI with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI should not be administered concomitantly with ethacrynic acid, furosemide, urea, or intravenous mannitol. The interaction between inhaled mannitol and TOBI has not been evaluated.
WARNINGS
Caution should be exercised when prescribing TOBI to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant parenteral aminoglycoside therapy should be monitored as clinically appropriate.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use TOBI during pregnancy, or become pregnant while taking TOBI should be apprised of the potential hazard to the fetus.
Ototoxicity
Ototoxicity, as measured by complaints of hearing loss or by audiometric evaluations, did not occur with TOBI therapy during clinical studies. However, transient tinnitus occurred in eight TOBI-treated patients versus no placebo patients in the clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution (see ADVERSE REACTIONS). Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
In postmarketing experience, patients receiving TOBI have reported hearing loss. Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus.
Nephrotoxicity
Nephrotoxicity was not seen during TOBI clinical studies but has been associated with aminoglycosides as a class. If nephrotoxicity occurs in a patient receiving TOBI, tobramycin therapy should be discontinued until serum concentrations fall below 2 mcg/mL.
Muscular Disorders
TOBI should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Bronchospasm
Bronchospasm has been reported with inhalation of TOBI. In clinical studies of TOBI, changes in FEV1 measured after the inhaled dose were similar in the TOBI and placebo groups. Bronchospasm should be treated as medically appropriate.
PRECAUTIONS
Information for Patients
NOTE: In addition to information provided below, a Patient Medication Guide providing instructions for proper use of TOBI is contained inside the package.
Safety Information
TOBI is in a class of antibiotics that have caused hearing loss, dizziness, kidney damage, and harm to a fetus. Ringing in the ears and hoarseness were two symptoms that were seen in more patients taking TOBI than placebo in research studies. Patients with cystic fibrosis can have many symptoms. Some of these symptoms may be related to your medications. If you have new or worsening symptoms, you should tell your doctor.
Hearing: You should tell your doctor if you have ringing in the ears, dizziness, or any changes in hearing.
Kidney Damage: Inform your doctor if you have any history of kidney problems.
Pregnancy: If you want to become pregnant or are pregnant while on TOBI, you should talk with your doctor about the possibility of TOBI causing any harm.
Nursing Mothers: If you are nursing a baby, you should talk with your doctor before using TOBI.
TOBI Packaging
TOBI comes in a single dose, ready-to-use ampule containing 300 mg tobramycin. Each foil pouch contains 4 ampules, for 2 days of TOBI therapy.
Dosage
The 300 mg dose of TOBI is the same for patients regardless of age or weight. TOBI has not been studied in patients less than 6 years old. Doses should be inhaled as close to 12 hours apart as possible and not less than 6 hours apart.
You should not mix TOBI with dornase alfa (PULMOZYME®, Genentech) in the nebulizer.
If you are taking several medications the recommended order is as follows: bronchodilator first, followed by chest physiotherapy, then other inhaled medications and, finally, TOBI.
Treatment Schedule
You should take TOBI in repeated cycles of 28 days on drug followed by 28 days off drug. You should take TOBI twice a day during the 28-day period on drug.
How To Administer TOBI
THIS INFORMATION IS NOT INTENDED TO REPLACE CONSULTATION WITH YOUR PHYSICIAN AND CF CARE TEAM ABOUT PROPERLY TAKING MEDICATION OR USING INHALATION EQUIPMENT.
TOBI is specifically formulated 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 are instructions on how to use the DeVilbiss Pulmo-Aide air compressor and PARI LC PLUS Reusable Nebulizer to administer TOBI.
You will need the following supplies:
- TOBI plastic ampule (vial)
- 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)