Tobramycin Inhalation Solution for Oral Inhalation

The following serious adverse reactions are described below and elsewhere in the labeling:

• Bronchospasm [see WARNINGS AND PRECAUTIONS]
• Ototoxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tobramycin inhalation solution was studied in two clinical studies in 258 cystic fibrosis patients ranging in age from 6 to 48 years. Patients received tobramycin inhalation solution 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. Adverse reactions reported in these studies are described below:

• The most frequent adverse reactions in the tobramycin inhalation arm were cough, pharyngitis, and increased sputum (see Table 1).
• Thirty-three patients (13%) treated with tobramycin inhalation solution complained of voice alteration compared to 17 (7%) placebo patients. Voice alteration was more common in the on-drug periods.
• Eight patients from the tobramycin inhalation solution group (3%) reported tinnitus compared to no placebo patients. All episodes were transient, resolved without discontinuation of the tobramycin inhalation solution treatment regimen, and were not associated with loss of hearing in audiograms.

Table 1 lists the percent of patients with selected adverse reactions that occurred in > 5% of tobramycin inhalation solution patients during the two Phase III studies.

Table 1: Percent of Patients With Selected Adverse Reactions Occurring in > 5% of Tobramycin Inhalation Solution Patients

Adverse Reaction	Tobramycin Inhalation Solution (n=258) %	Placebo (n=262) %
Cough Increased	46.1	47.3
Pharyngitis	38.0	39.3
Sputum Increased	37.6	39.7
Dyspnea	33.7	38.5
Hemoptysis	19.4	23.7
Lung Function Decreased1	16.3	15.3
Voice Alteration	12.8	6.5
Taste Perversion	6.6	6.9
Rash	5.4	6.1
1Includes reported decreases in pulmonary function tests or decreased lung volume on chest radiograph associated with intercurrent illness or study drug administration.

Selected adverse reactions that occurred in less than or equal to 5% of patients treated with tobramycin inhalation solution

Ear and Labyrinth Disorders

Tinnitus

Musculoskeletal and Connective Tissue Disorders

Myalgia

Infections and Infestations

Laryngitis

Postmarketing Experience

The following adverse reactions have been identified during post approval use of tobramycin inhalation solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ear and Labyrinth Disorders

Hearing loss: Some of these reports occurred in patients with previous or concomitant treatment with systemic aminoglycosides. Patients with hearing loss frequently reported tinnitus. [see WARNINGS AND PRECAUTIONS]

Skin and Subcutaneous Tissue Disorders

Hypersensitivity, pruritus, urticaria, rash

Nervous system Disorders

Aphonia, dysgeusia

Respiratory, Thoracic, and Mediastinal Disorders

Bronchospasm [see WARNINGS AND PRECAUTIONS], oropharyngeal pain

Read the entire FDA prescribing information for Kitabis Pak (Tobramycin Inhalation Solution for Oral Inhalation)

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