Rx Product News Profile: A closer look at new FDA actions

Dr. Holmberg is the pharmacy coordinator at Desert Vista Behavioral Health Center in Mesa, Arizona.

Meda Pharmaceuticals’ Astepro

The FDA has approved Meda Pharmaceuticals’ Astepro (azelastine HCl) Nasal Spray 0.15% for the treatment of seasonal and perennial allergic rhinitis in patients 12 years of age and older.¹ Astepro was originally formulated and marketed as 0.1%; however, the new product is 50% more concentrated than the original, allowing for once-daily administration in patients with seasonal allergic rhinitis. Astepro is the first nasal antihistamine to be available with once-daily dosing.²

An estimated 40 million Americans experience seasonal and perennial allergic rhinitis. Seasonal allergic rhinitis usually occurs during specific seasons, such as spring and fall, and is due to outdoor allergens such as tree, grass, or ragweed pollen.

Perennial allergic rhinitis occurs year-round and is due to indoor allergy sources, such as dust mites, mold, and animal dander. Symptoms of both forms of allergic rhinitis include nasal congestion, runny nose, sneezing, and itching of the nose.¹

Mechanism of Action

Astepro is a phthalazinone derivative that displays histamine H1-receptor antagonist activity.³

Clinical Trials

Astepro was evaluated in a total of 7 double-blind, placebo-controlled clinical trials that lasted from 2 to 4 weeks. At the studies’ end, patients using Astepro reported a significant improvement in their total nasal symptom score, which evaluated a combination of rhinorrhea, nasal congestion, sneezing, and nasal itching.²

Dosage and Administration

For the treatment of seasonal allergic rhinitis, Astepro 0.15% should be dosed as either 1 or 2 sprays in each nostril twice a day or as 2 sprays in each nostril once daily.

For the treatment of perennial allergic rhinitis, Astepro 0.15% should be dosed as 2 sprays in each nostril twice a day.³

Contraindications, Warnings, Precautions, and Adverse Reactions

No contraindications exist with the use of Astepro. Some patients using Astepro may experience somnolence; hazardous conditions that require complete mental alertness, such as driving or operating heavy machinery, should be avoided. Patients should not use alcohol or other central nervous system (CNS) depressants while concurrently using Astepro, as their depressant effects may be exacerbated when used in combination.

Astepro is a Pregnancy Category C drug. It is not known if it is excreted into human milk; caution should be used when Astepro is given to patients who are breast-feeding.

The most commonly reported adverse reactions to Astepro are bitter taste, nasal discomfort, epistaxis, headache, fatigue, somnolence, and sneezing.³

Patient Counseling

Patients should be aware that treatment with Astepro may result in somnolence, and they should use caution when performing tasks that require mental alertness. Advise patients to avoid alcohol or other CNS depressants during treatment with Astepro. Astepro Nasal Spray must be primed prior to its first use, or if it has not been used for 3 or more days. To prime the unit for its initial use, release 6 sprays or until a fine mist appears. To reprime the unit after 3 or more days of abstinence, release 2 sprays or until a fine mist appears.

Avoid spraying Astepro in the eyes or mouth. Astepro should be kept out of the reach of children. â– 

To use Astepro Nasal Spray:

1. Clear nostrils by blowing nose gently.

2.

Tilt head downwards.

3.

Place spray tip ¼ to ½ inch into one nostril. Keep the bottle upright and aim the

spray tip towards the back of the nose.

4.

Use a finger to close the opposite nostril. Depress the pump once while

simultaneously sniffing. Keep head tilted forward and down.

5.

Repeat with opposite nostril.

6.

Repeat steps 2 through 5 if a second spray is required.

7.

After using Astepro, do not tilt the head backwards.

8.

After using Astepro, wipe the spray tip with a clean tissue or cloth and replace the

safety clip and dust cover.³

References

1. Meda receives FDA approval of new Astepro (azelastine HCl) nasal spray 0.15%, the first and only once-daily nasal antihistamine Available at http://www.medpointepharma.com/mediacenter/pdf/2September2009.pdf Accessed November 2009.

2. Once-Daily Azelastine Nasal Spray Approved for Seasonal Allergies Available at

http://www.medscape.com/viewarticle/708306 Accessed November 2009.

3. Astepro Complete Prescribing Information. Available at http://www.astepro.com/pdf/15percentPI.pdf Accessed November 2009.