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TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder)
Tudorza Pressair
Forest Laboratories, Inc.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TUDORZA PRESSAIR safely and effectively. See full prescribing information for TUDORZA PRESSAIR.
TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder)
FOR ORAL INHALATION ONLY
Initial U.S. Approval: 2012
INDICATIONS AND USAGE
TUDORZA PRESSAIR is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only
■One inhalation of TUDORZA PRESSAIR 400 mcg twice daily. (2)
DOSAGE FORMS AND STRENGTHS
■Inhalation powder; The multi-dose device is a dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
■Not for acute use: Not for use as a rescue medication. (5.1)
■Paradoxical bronchospasm: Discontinue TUDORZA PRESSAIR and consider other treatments if paradoxical bronchospasm occurs. (5.2)
■Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. (5.3)
■Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs. (5.4)
■Immediate hypersensitivity reactions: Use with caution in patients with severe hypersensitivity to milk proteins. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (≥3% incidence and greater than placebo) are headache, nasopharyngitis and cough. (6.1)
To report SUSPECTED ADVERSE REACTIONS, Contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of TUDORZA PRESSAIR with other anticholinergic-containing drugs. (7.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 07/2012
FULL PRESCRIBING INFORMATION: CONTENTS *
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Not for Acute Use
5.2 Paradoxical Bronchospasm
5.3 Worsening of Narrow-Angle Glaucoma
5.4 Worsening of Urinary Retention
5.5 Immediate Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Sympathomimetics, Methylxanthines, Steroids
7.2 Anticholinergics
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
10.1 Human Experience
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Chronic Obstructive Pulmonary Disease (COPD)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
17.1 Instructions for Administering TUDORZA PRESSAIR
17.2 Acute Bronchospasm
17.3 Paradoxical Bronchospasm
17.4 Visual Effects
17.5 Urinary Retention
*
Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
11 INDICATIONS AND USAGE
TUDORZA™ PRESSAIR™ (aclidinium bromide inhalation powder) is indicated for the long-term, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
22 DOSAGE AND ADMINISTRATION
The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily.
33 DOSAGE FORMS AND STRENGTHS
Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation. Each actuation delivers 375 mcg of aclidinium bromide from the mouthpiece.
44 CONTRAINDICATIONS
None.
55 WARNINGS AND PRECAUTIONS
5.15.1 Not for Acute Use
TUDORZA PRESSAIR is intended as a twice-daily maintenance treatment for COPD and is not indicated for the initial treatment of acute episodes of bronchospasm (i.e., rescue therapy).
5.25.2 Paradoxical Bronchospasm
Inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If this occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered.
5.35.3 Worsening of Narrow-Angle Glaucoma
TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
5.45.4 Worsening of Urinary Retention
TUDORZA PRESSAIR should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of prostatic hyperplasia or bladder-neck obstruction (e.g., difficulty passing urine, painful urination). Instruct patients to consult a physician immediately should any of these signs or symptoms develop.
5.55.5 Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of TUDORZA PRESSAIR. If such a reaction occurs, therapy with TUDORZA PRESSAIR should be stopped at once and alternative treatments should be considered. Given the similar structural formula of atropine to aclidinium, patients with a history of hypersensitivity reactions to atropine should be closely monitored for similar hypersensitivity reactions to TUDORZA PRESSAIR. In addition, TUDORZA PRESSAIR should be used with caution in patients with severe hypersensitivity to milk proteins.
66 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections:
-
Paradoxical bronchospasm[see Warnings and Precautions (5.2)]
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Worsening of narrow-angle glaucoma[see Warnings and Precautions (5.3)]
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Worsening of urinary retention[see Warnings and Precautions (5.4)]
6.16.1 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.
3-Month and 6-Month Trials
TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily.
The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.
Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 1% in the TUDORZA PRESSAIR group in the two 3-month and one 6-month placebo-controlled trials where the rates in the TUDORZA PRESSAIR group exceeded placebo.
Table 1: Adverse Reactions (% Patients) in Placebo-Controlled Clinical Trials
|
|
Treatment |
|
Adverse Reactions |
TUDORZA PRESSAIR |
Placebo |
|
Preferred Term |
(N=636) |
(N=640) |
|
|
n (%) |
n (%) |
|
Headache |
42 (6.6) |
32 (5.0) |
|
Nasopharyngitis |
35 (5.5) |
25 (3.9) |
|
Cough |
19 (3.0) |
14 (2.2) |
|
Diarrhea |
17 (2.7) |
9 (1.4) |
|
Sinusitis |
11 (1.7) |
5 (0.8) |
|
Rhinitis |
10 (1.6) |
8 (1.2) |
|
Toothache |
7 (1.1) |
5 (0.8) |
|
Fall |
7 (1.1) |
3 (0.5) |
|
Vomiting |
7 (1.1) |
3 (0.5) |
In addition, among the adverse reactions observed in the clinical trials with an incidence of less than 1% were diabetes mellitus, dry mouth, 1st degree AV block, osteoarthritis, cardiac failure, and cardio-respiratory arrest.
Long-term Safety Trials
TUDORZA PRESSAIR was studied in three long term safety trials, two double blind and one open label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. Two of these trials were extensions of the 3-month trials, and one was a dedicated long term safety trial. In these trials, 891 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily. The demographic and baseline characteristics of the long term safety trials were similar to those of the placebo-controlled trials. The adverse events reported in the long term safety trials were similar to those occurring in the placebo-controlled trials of 3 to 6 months. No new safety findings were reported compared to the placebo controlled trials.
77 DRUG INTERACTIONS
In vitrostudies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with TUDORZA PRESSAIR[see Clinical Pharmacology (12.3)].
7.17.1 Sympathomimetics, Methylxanthines, Steroids
In clinical studies, concurrent administration of aclidinium bromide and other drugs commonly used in the treatment of COPD including sympathomimetics (short-acting beta2agonists), methylxanthines, and oral and inhaled steroids showed no increases in adverse drug reactions.
7.27.2 Anticholinergics
There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of TUDORZA PRESSAIR with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.
88 USE IN SPECIFIC POPULATIONS |
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