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warnings
WARNINGS 1. Paradoxical Bronchospasm Like other inhaled beta-adrenergic agonists, Levalbuterol HCl Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Levalbuterol HCl Inhalation Solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. 2. Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Levalbuterol HCl Inhalation Solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 3. Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. 4. Cardiovascular Effects Levalbuterol HCl Inhalation Solution, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Levalbuterol HCl Inhalation Solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Levalbuterol HCl Inhalation Solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 5. Do Not Exceed Recommended Dose Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. 6. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Levalbuterol HCl Inhalation Solution.
ADVERSE REACTIONS (Adults and Adolescents ≥12 years old) Adverse events reported in ≥2% of patients receiving Levalbuterol HCl Inhalation Solution or racemic albuterol and more frequently than in patients receiving placebo in a 4-week, controlled clinical trial are listed in Table 3 . Table 3: Adverse Events Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥12 years old Percent of Patients Body System Preferred Term Placebo (n=75) Levalbuterol HCl 1.25 mg (n=73) Levalbuterol HCl 0.63 mg (n=72) Racemic albuterol 2.5 mg (n=74) Body as a Whole Allergic reaction 1.3 0 0 2.7 Flu syndrome 0 1.4 4.2 2.7 Accidental injury 0 2.7 0 0 Pain 1.3 1.4 2.8 2.7 Back pain 0 0 0 2.7 Cardiovascular System Tachycardia 0 2.7 2.8 2.7 Migraine 0 2.7 0 0 Digestive System Dyspepsia 1.3 2.7 1.4 1.4 Musculoskeletal System Leg cramps 1.3 2.7 0 1.4 Central Nervous System Dizziness 1.3 2.7 1.4 0 Hypertonia 0 0 0 2.7 Nervousness 0 9.6 2.8 8.1 Tremor 0 6.8 0 2.7 Anxiety 0 2.7 0 0 Respiratory System Cough increased 2.7 4.1 1.4 2.7 Infection viral 9.3 12.3 6.9 12.2 Rhinitis 2.7 2.7 11.1 6.8 Sinusitis 2.7 1.4 4.2 2.7 Turbinate edema 0 1.4 2.8 0 The incidence of certain systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was slightly less in the Levalbuterol HCl 0.63 mg group compared with the other active treatment groups. The clinical significance of these small differences is unknown. Changes in heart rate 15 minutes after drug administration and in plasma glucose and potassium 1 hour after drug administration on day 1 and day 29 were clinically comparable in the Levalbuterol HCl 1.25 mg and racemic albuterol 2.5 mg groups (see Table 4 ). Changes in heart rate and plasma glucose were slightly less in the Levalbuterol HCl 0.63 mg group compared with the other active treatment groups (see Table 4 ). The clinical significance of these small differences is unknown. After 4 weeks, effects on heart rate, plasma glucose, and plasma potassium were generally diminished compared with day 1 in all active treatment groups. Table 4: Mean Changes from Baseline Heart Rate at 15 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) in Adults and Adolescents ≥12 years old Mean Changes (day 1) Treatment Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol HCl 0.63 mg, n=72 2.4 4.6 –0.2 Levalbuterol HCl 1.25 mg, n=73 6.9 10.3 –0.3 Racemic albuterol 2.5 mg, n=74 5.7 8.2 –0.3 Placebo, n=75 –2.8 –0.2 –0.2 No other clinically relevant laboratory abnormalities related to administration of Levalbuterol HCl Inhalation Solution were observed in this study. In the clinical trials, a slightly greater number of serious adverse events, discontinuations due to adverse events, and clinically significant ECG changes were reported in patients who received Levalbuterol HCl 1.25 mg compared with the other active treatment groups. The following adverse events, considered potentially related to Levalbuterol HCl, occurred in less than 2% of the 292 subjects who received Levalbuterol HCl and more frequently than in patients who received placebo in any clinical trial: Body as a Whole: chills, pain, chest pain Cardiovascular System: ECG abnormal, ECG change, hypertension, hypotension, syncope Digestive System: diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea Hemic and Lymphatic System: lymphadenopathy Musculoskeletal System: leg cramps, myalgia Nervous System: anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor Special Senses: eye itch The following events, considered potentially related to Levalbuterol HCl, occurred in less than 2% of the treated subjects but at a frequency less than in patients who received placebo: asthma exacerbation, cough increased, wheezing, sweating, and vomiting.
adverse reactions
ADVERSE REACTIONS (Children 6-11 years old) Adverse events reported in ≥2% of patients in any treatment group and more frequently than in patients receiving placebo in a 3-week, controlled clinical trial are listed in Table 5 . Table 5: Most Frequently Reported Adverse Events (≥2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old) Percent of Patients Body System Preferred Term Placebo (n=59) Levalbuterol HCl 0.31 mg (n=66) Levalbuterol HCl 0.63 mg (n=67) Racemic albuterol 1.25 mg (n=64) Racemic albuterol 2.5 mg (n=60) Body as a Whole Abdominal pain 3.4 0 1.5 3.1 6.7 Accidental injury 3.4 6.1 4.5 3.1 5.0 Asthenia 0 3.0 3.0 1.6 1.7 Fever 5.1 9.1 3.0 1.6 6.7 Headache 8.5 7.6 11.9 9.4 3.3 Pain 3.4 3.0 1.5 4.7 6.7 Viral Infection 5.1 7.6 9.0 4.7 8.3 Digestive System Diarrhea 0 1.5 6.0 1.6 0 Hemic and Lymphatic Lymphadenopathy 0 3.0 0 1.6 0 Musculoskeletal System Myalgia 0 0 1.5 1.6 3.3 Respiratory System Asthma 5.1 9.1 9.0 6.3 10.0 Pharyngitis 6.8 3.0 10.4 0 6.7 Rhinitis 1.7 6.1 10.4 3.1 5.0 Skin and Appendages Eczema 0 0 0 0 3.3 Rash 0 0 7.5 1.6 0 Urticaria 0 0 3.0 0 0 Special Senses Otitis Media 1.7 0 0 0 3.3 Note: Subjects may have more than one adverse event per body system and preferred term. Changes in heart rate, plasma glucose, and serum potassium are shown in Table 6 . The clinical significance of these small differences is unknown. Table 6: Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in Children 6-11 years old Mean Changes (Day 1) Treatment Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol HCl 0.31 mg, n=66 0.8 4.9 –0.31 Levalbuterol HCl 0.63 mg, n=67 6.7 5.2 –0.36 Racemic albuterol 1.25 mg, n=64 6.4 8.0 –0.27 Racemic albuterol 2.5 mg, n=60 10.9 10.8 –0.56 Placebo, n=59 –1.8 0.6 –0.05 Mean Changes (Day 21) Treatment Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol HCl 0.31 mg, n= 60 0 2.6 –0.32 Levalbuterol HCl 0.63 mg, n=66 3.8 5.8 –0.34 Racemic albuterol 1.25 mg, n= 62 5.8 1.7 –0.18 Racemic albuterol 2.5 mg, n= 54 5.7 11.8 –0.26 Placebo, n= 55 –1.7 1.1 –0.04
adverse reactions
POSTMARKETING ADVERSE REACTIONS In addition to the adverse events reported in clinical trials, the following adverse events have been observed in postapproval use of Levalbuterol HCl Inhalation Solution. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dyspnea, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria. Because these events have been reported spontaneously from a population of unknown size, estimates of frequency cannot be made.