Astepro

Frequently Asked Questions for Pharmacists About ASTEPRO® (azelastine HCI) Nasal Spray 0.15%

Q: Is original ASTEPRO still commercially available?

A: No. ASTEPRO 0.15%, 205.5 mcg, is the only ASTEPRO formulation available.

Q: Why is original ASTEPRO no longer available?

A: After completing a comprehensive review of the ASTEPRO family of products, Meda Pharmaceuticals decided to discontinue the manufacturing, distribution, and marketing of original ASTEPRO, 137 mcg. ASTEPRO 0.15%, 205.5 mcg, offers a combination of benefits that makes it different from other antihistamines. Meda will continue to manufacture, distribute, and market ASTEPRO 0.15%.

Q: What are the indications and dosing regimens for ASTEPRO 0.15% compared with other nasal azelastine products?

A: ASTEPRO 0.15% is the first nasal antihistamine with an indication for seasonal allergic rhinitis (SAR) (once- or twice-daily dosing) and perennial allergic rhinitis (PAR) (twice-daily dosing). ASTEPRO is indicated for the relief of symptoms of SAR in patients 12 years of age and older and dosed BID.

Q: ASTEPRO 0.15% is made by the same company that makes original ASTEPRO and ASTELIN. Is ASTEPRO 0.15% interchangeable with original ASTEPRO and/or ASTELIN?

A: No. The products are NOT AB rated and therefore are not interchangeable. ASTEPRO 0.15% contains 205.5 mcg of azelastine HCI in each 0.137 mL spray. Original ASTEPRO and ASTELIN contain 137 mcg of azelastine HCI in each 0.137 mL spray. Furthermore, the products have different indications and dosing regimens. Do not substitute with another azelastine HCI formulation; please dispense ASTEPRO 0.15% as prescribed.

Q: What is the dosing regimen for ASTEPRO 0.15%?

A: The FDA-recommended dosage for ASTEPRO 0.15% is 2 sprays per nostril QD or 1 to 2 sprays per nostril BID in patients 12 years of age and older with SAR and 2 sprays per nostril BID in patients 12 years of age and older with PAR.

Q: What are the most commonly reported adverse events in the 2- to 4-week SAR and PAR trials with ASTEPRO 0.15%?

A: The most commonly reported adverse events when ASTEPRO 0.15% was dosed 2 sprays per nostril (once daily or twice daily, respectively) for SAR and PAR included bitter taste (4%, 6%), nasal discomfort (4%, 3%), epistaxis (2%, 1%), and sneezing (1%, 2%).

Q: What is the order number for ASTEPRO 0.15%?

A: The NDC number for ASTEPRO 0.15% is 0037-0243-30 and is supplied as one (30 mL) bottle, which contains 200 metered sprays.

Q: What should pharmacists do with their remaining stock of original ASTEPRO and ASTELIN?

A: Pharmacists should sell their remaining stock of original ASTEPRO and ASTELIN, and continue to reorder ASTEPRO 0.15%.

Q: Can a pharmacist send ASTELIN and original ASTEPRO back to the wholesaler for credit?

A: The normal Meda return policy applies for ASTELIN and original ASTEPRO Nasal Spray.