Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
active ingredients: 5 mg capsule: Mannitol (E421), 10 mg capsule: Mannitol (E421), 20 mg capsule: Mannitol (E421), 40 mg capsule: Mannitol (E421)
laboratory: Pharmaxis Pharma Ltd

Inhalation powder in capsule
Kit of 19 Capsules (+ 1 inhaler)
All forms

Indication

This medicine is for diagnostic use only.

Aridol is indicated for the identification of bronchial hyperreactivity in subjects with a baseline maximum excretion volume (FEV1) greater than or equal to 70% of the theoretical values.

Dosage ARIDOL Powder for inhalation in capsule Kit of 19 Capsules (+ 1 inhaler)

Dosage

In the adult

The capsules are available in a kit containing an inhaler and a sufficient number of capsules to perform a challenge test at the maximum dose.

The bronchial response to A ridol is measured by changes in FEV1.

Pediatric population

The A ridol test should not be used in children under 6 years of age because it is not possible to obtain reproducible spirometric measurements at this age (see section 5.1 ).

The available data on the use of A ridol in patients aged 6 to 18 years being limited, the use of A ridol is not recommended in this population

Administration mode

Before performing the provocation test, spirometry must be performed. Basal FEV1 should be reproducible.

The patient must be seated comfortably. He must have a good position to facilitate an effective release of A ridol in the airways. The test should be conducted as follows:

1. Place a nose clip and tell the patient to breathe through their mouth.

2. Insert the 0 mg capsule into the inhaler. Pierce the capsule by gently pressing the two buttons of the device: press once, a second maneuver could burst the capsule.

3. The patient must first exhale all air from his lungs before inhaling the powder through the inhaler. Inhalation must be deep, fast and controlled.

4. At the end of the deep breath, start a stopwatch. The patient must hold his breath for 5 seconds and then exhale through the mouth before removing the nose clip.

5. After 60 seconds, FEV1 is measured at least twice to obtain two reproducible measurements. The highest value is basal FEV1. The target FEV1 is then calculated by multiplying the basal FEV1 by 0.85.

6. Insert the 5 mg capsule into the inhaler and proceed as above.

7. Repeat steps 1-5 by increasing the incremental doses, as indicated in the following table, until a positive response is obtained or a maximum cumulative dose of 635 mg.

Increased doses during an ARIDOL challenge test

Dose n °

Mg dose

Cumulative mg dose

Capsules per dose

1

0

0

1

2

5

5

1

3

10

15

1

4

20

35

1

5

40

75

1

6

80

155

2 x 40 mg

7

160

315

4 x 40 mg

8

160

475

4 x 40 mg

9

160

635

4 x 40 mg

A positive answer corresponds to one of the following results:

· 15% decrease in FEV1 compared to baseline (0 mg dose)

or

· 10% decrease in FEV1 observed between two successive doses

Examples of positive tests:

1. Decreased FEV1 after dose of Step 2: 3%

Decreased FEV1 after dose of Step 3: 8%

Decreased FEV1 after dose in Step 4: 16%

o The total decrease is 16% (≥ 15%), so the test is positive.

2. Decreased FEV1 after step 2 dose: 3%

Decreased FEV1 after dose of Step 3: 14%

o Although the total decrease is <15%, the decrease observed between two successive doses is 11% (≥ 10%), so the test is positive.

Important points :

1. Always observe a minimum delay between the measurement of FEV1 and the next dose to achieve a cumulative bronchial osmotic effect.

2. Always obtain at least two acceptable measures of FEV1 after each dose. It is sometimes necessary to practice more than 2 measurements, especially in case of variability between the measurements or in case of mishandling during the measurement (eg the patient started to cough).

3. The doses of 80 mg and 160 mg are achieved using several 40 mg capsules (i.e., 2 x 40 mg and 4 x 40 mg, respectively). For these specific doses, do not wait between each capsule administration: administer all capsules in sequence until the total dose has been inhaled.

4. After inhalation of a dose, always make sure that the capsule is empty. It is possible to perform a second inhalation from the same capsule if there is powder in the capsule.

Most patients recover spontaneously after the challenge test. However, when the provocation test is positive or if asthma worsens, administer a standard dose of beta 2 -agonist to speed up recovery. It is also possible to administer a standard dose of beta 2 -agonist to accelerate recovery in subjects whose challenge test is negative. After administration of a beta 2 -agonist, FEV1 generally returns to baseline in 10-20 minutes. Monitor patients until FEV1 returns to baseline (± 5%).

Against indications

Hypersensitivity to mannitol or any of the excipients in the capsule.

Aridol should not be administered to patients with severe bronchial obstruction (FEV1 <50% of theoretical or <1.0 L) or whose condition is likely to worsen in the event of bronchospasm or repeated expirations. The provocation test is contraindicated especially in patients who have suffered from aneurysm of the aortic or cerebral aneurysm, uncontrolled hypertension, myocardial infarction or stroke during the six last months.

Aridol side effects

Summary of the security profile

A positive reaction to A ridol may result in symptoms of bronchospasm, such as chest tightness, coughing, or wheezing.

The population considered for safety profiling included 1, 046 subjects, including patients with asthma or symptoms suggestive of asthma and healthy individuals aged 6 to 83 who participated in both clinical trials. The racial distribution of the subjects was as follows: 84% of Caucasian subjects, 5% of Asian subjects, 4% of black subjects and 7% of other subjects. In the DPM-A-301 study, adverse events were monitored from the start of the challenge trial to one week after the day of the test. In the DPM-A-305 study, adverse events were reported at the time of testing and the following day. No serious adverse events were reported following the bronchial challenge with A ridol in either trial. Since the half-life of mannitol is short, it is expected that the cause-effect relationship will decrease during the same period. No serious adverse events were reported during the study. Most of the reported adverse events were mild and transient.

Most patients experienced coughing during the provocation test. However, in the majority of cases (87%), it was only occasional. In other patients, it was frequent enough to delay the continuation of the test (13%), or even to interrupt (1%). Pharyngolaryngeal pain has also been reported frequently; its occurrence may be diminished by rinsing the subject's mouth after the test. In five adult subjects (0.6%), studies were discontinued within one day after Aridol administration due to cough, decreased lung function, nervousness, a sore throat or an irritation of the throat. In one subject (0.4%), studies were discontinued less than one day after administration of A ridol because of gagging.

Table of adverse reactions

The adverse reactions reported in both studies are listed below by organ class and absolute frequency. Very common (1/10), Common (1/100, <1/10), Uncommon ( ³ 1) / 1000, <1/100), Rare (1/10 000, <1/1000), Very rare (<1/10 000)

Infections and infestations

Common: Rhinopharyngitis.

Nervous system disorders

Common: Headache

Uncommon: dizzy state.

Eye disorders

Uncommon: Eye irritation.

Vascular disorders:

Uncommon: Flushing, coldness of the extremities.

Respiratory, thoracic and mediastinal disorders

Common: Pharyngolaryngeal pain, cough *, rhinorrhea, throat irritation, aggravated asthma, dyspnea.

Uncommon: Hoarseness, epistaxis, decreased oxygen saturation.

Gastrointestinal disorders

Common: Nausea, vomiting.

Uncommon: Upper abdominal pain, diarrhea, oral ulceration.

Skin and subcutaneous tissue disorders

Uncommon: Pruritus, hyperhidrosis.

Musculoskeletal and systemic disorders:

Uncommon: Musculoskeletal pain.

General disorders and administration site defects:

Common: Thoracic oppression

Uncommon: Fatigue, feeling nervous, thirsty.

* Cough was only considered an adverse event if it occurred during the provocation test and resulted in discontinuation of the test.

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