FDA Approves Aridol

The United States Food and Drug Administration (FDA) has approved Aridol (mannitol inhalation powder) Bronchial Challenge Test Kit for marketing.

The FDA has approved Aridol for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma. Aridol should not be used as a standalone tool to assess asthma, but as part of a physicians overall assessment of asthma.

Highlights of Aridol Prescribing Information

These highlights do not include all the information needed to use Aridol safely and effectively. See full prescribing information for Aridol.

Aridol Indications and Usage

Mannitol, the active ingredient in Aridol, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.

Limitations of Use: Aridol is not a stand alone 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.

Dosage and Administration

For Oral Inhalation Use Only

• One Aridol test kit contains dry powder mannitol capsules in graduated doses and a single patient use inhaler necessary to perform one bronchial challenge test.
• The mannitol capsules supplied in the Aridol kit are to be used with the single patient use inhaler device. Discard the inhaler after use.
• Capsule contents are to be inhaled in increasing dosage until either a positive response (15% reduction in FEV1 from baseline or a 10% incremental reduction in FEV1 between consecutive doses) is achieved or all capsules are inhaled (maximum total dose 635mg)
• Starting and maximum dose is the same for children (≥ 6 years old) and adults

Dosage Forms and Strengths

Inhalation powder. One test kit contains dry powder mannitol capsules n graduated doses of 0mg, 5mg, 10mg, 20mg, and 40mg and one single patient use dry powder inhaler device

Contraindications

• Known hypersensitivity to mannitol or to the gelatin used to make the capsules
• Conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers

• 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.
• 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.

For Oral Inhalation Use Only

• One Aridol test kit contains dry powder mannitol capsules in graduated doses and a single patient use inhaler necessary to perform one bronchial challenge test.
• The mannitol capsules supplied in the Aridol kit are to be used with the single patient use inhaler device. Discard the inhaler after use.
• Capsule contents are to be inhaled in increasing dosage until either a positive response (15% reduction in FEV1 from baseline or a 10% incremental reduction in FEV1 between consecutive doses) is achieved or all capsules are inhaled (maximum total dose 635mg)
• Starting and maximum dose is the same for children (≥ 6 years old) and adults

Dosage Forms and Strengths

Inhalation powder. One test kit contains dry powder mannitol capsules n graduated doses of 0mg, 5mg, 10mg, 20mg, and 40mg and one single patient use dry powder inhaler device

Most common adverse reactions (rate ≥1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness.

To report SUSPECTED ADVERSE REACTIONS, contact Pharmaxis Inc. at 1-888-659-6396 or email at [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No formal drug-drug interaction studies have been conducted with Aridol