FDA

Aridol

Approved 5 Oct 2010InhalationPowder

The FDA lists this product in 3 strengths and forms.

Indications

ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma. ARIDOL is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma.

( 1 ) Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Contraindications

ARIDOL is contraindicated in: Patients with known hypersensitivity to mannitol or to the gelatin used to make the capsules Patients with conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers. Some examples include: aortic or cerebral aneurysm, uncontrolled hypertension, recent myocardial infarction or cerebral vascular accident [ see Warnings and Precautions ( 5.2 )]. Known hypersensitivity to mannitol or to the gelatin used to make the capsules ( 4 ) Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers ( 4 )

Warnings and precautions

& PRECAUTIONS Severe bronchospasm: ARIDOL may cause severe bronchospasm in susceptible patients. Administer by trained professionals under the supervision of a physician. Medications and equipment to treat severe bronchospasm must be present in the testing area. ( 5.1 ) Subjects with co-morbid conditions: Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant.

( 5.2 )

5.1Severe Bronchospasm Mannitol,

the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm in susceptible patients. The test should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Patients should not be left unattended during the bronchial challenge test. Medications and equipment to treat severe bronchospasm must be present in the testing area.

At a glance

Brand name: Aridol
Active substance: mannitol
Route: Inhalation
Dosage form: Powder
Applicant: Pharmaxis Europe
Status: Prescription
FDA approval: 5 Oct 2010
Application: NDA022368-003

Indications

Contraindications

Warnings and precautions

( 5.2 )

5.1Severe Bronchospasm Mannitol,

Adverse reactions

The following clinically significant adverse reaction is described elsewhere in the labeling:

Severe Bronchospasm [ see Warnings and Precautions ( 5.1 )]. Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm, Inc. at 1-866-701-4636 or email at medinfo@methapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical 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. The safety population for the ARIDOL bronchial challenge test consisted of 1,082 subjects (577 females and 505 males) including patients with asthma, symptoms suggestive of asthma, and healthy individuals from 6 to 83 years of age who participated in the two clinical trials (Studies 1 and 2).

The racial distribution of subjects was 84% Caucasian, 5% Asian, 4% Black, and 7% Other. Pediatric and adolescents patients comprised 23% of the total study population with 118 pediatric patients aged 6-11 years and 128 adolescents aged 12-17 years. Adverse reactions were reported at the time of the testing procedure and for one day thereafter. No serious adverse reactions were reported following bronchial challenge testing with ARIDOL in either trial.

Five adult subjects (0.6%) discontinued from the studies within a day following bronchial challenge testing with ARIDOL because of cough, decreased lung function, feeling jittery, sore throat, and throat irritation. One adult subject (0.3%) discontinued following the methacholine bronchial challenge test because of dizziness. One pediatric subject (0.4%) discontinued from the studies within a day following bronchial challenge testing with ARIDOL because of retching.

Table 2 displays the combined common adverse reactions (≥1%) within a day after bronchial challenge testing with ARIDOL or methacholine in the overall population for Studies 1 and 2. Table 2: Adverse reactions with an incidence ≥1% within a day after bronchial challenge testing (overall population, Studies 1 and 2 combined) Adverse Reactions Treatment ARIDOL (N=1046) n (%) Methacholine Challenge (N=420) n (%) Headache 59 (6) 4 (1) Pharyngolaryngeal pain 25 (2) 0 Throat irritation 19 (2) 1 (<1) Nausea 19 (2) 0 Cough 17 (2) 8 (2) Rhinorrhea 16 (2) 0 Dyspnea 15 (1) 21 (5) Chest discomfort 13 (1) 18 (4) Wheezing 8 (1) 6 (1) Retching 6 (1) 0 Dizziness 5 (1) 13 (3) The maximum reduction in FEV 1 following bronchial challenge testing with ARIDOL was 46%, compared to 54% for exercise testing and 67% for the methacholine challenge.

The incidences in decreases in FEV 1 ≥30% and ≥60% following ARIDOL, methacholine, and exercise challenges for Studies 1 and 2 is shown in Table 3. Table 3: Incidence of decreases in FEV 1 ≥30% or ≥60% (overall population, Studies 1 and 2) Challenge No. Exposed N (%) with Fall in FEV 1 ≥30% N (%) with Fall in FEV 1 ≥60% Study 1 Exercise 435 27 (6%) 0 Methacholine 420 51 (12%) 3 (1%) ARIDOL 419 3 (1%) 0 Study 2 ARIDOL asthmatics 536 23 (4%) 0 ARIDOL Non-asthmatics 91 0 0 There were no differences in the incidence of adverse reactions based on gender or race.

The clinical trials did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently compared to subjects below 65 years of age. Pediatric Patients Aged 6 to 17 Years: Overall, the types and severities of adverse reactions in children were similar to those observed in the adult population. As in the adult population, the adverse reactions of pharyngolaryngeal pain, nausea, and headache were the more common with incidences of 4%, 3%, and 3%, respectively.

There were no major differences in the types of adverse reactions observed in children 6-11 years of age compared to adolescents 12-17 years old. The decrease in FEV 1 in pediatric patients and adolescents who received the ARIDOL bronchial challenge test was similar to that of the adult population with 5%, 15% and 9% of pediatric patients who had bronchial challenge testing with ARIDOL, methacholine and exercise, respectively, experiencing reduction in FEV 1 ≥30%.

No patient who had bronchial challenge testing with ARIDOL or exercise had a decrease in FEV 1 ≥60%, whereas, one adolescent patient (aged 12 years) who received methacholine had a decrease in FEV 1 ≥60%.

6.2Post-Marketing Experience

The following adverse reactions have been identified post approval outside the U.S. of the ARIDOL Bronchial Challenge Test Kit: cough, gagging, wheeze, and decreased forced expiratory volume. 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.

Aridol

Indications

Contraindications

Warnings and precautions

5.1Severe Bronchospasm Mannitol,

At a glance

Two medicines in one question?

Aridol

Indications

Contraindications

Warnings and precautions

5.1Severe Bronchospasm Mannitol,

At a glance

Two medicines in one question?

5.2Subjects with Co-morbid Conditions

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Post-Marketing Experience

Composition

Strengths and forms

Official product information