Brovana (Arformoterol Tartrate Inhalation) - Description

*potency expressed as arformoterol

For oral inhalation only

DESCRIPTION

BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol.

Arformoterol is a selective beta₂-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows:

The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C₁₉H₂₄N₂O₄۰C₄H₆O₆ (1:1 salt). It is a white to off-white solid that is slightly soluble in water.

Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate.

BROVANA is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) ready-to-use vials. Each ready-to-use vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate.

BROVANA requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC PLUS^® nebulizer (with mouthpiece) connected to a PARI DURA-NEB^® 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece (see Dosage and Administration).

Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Medication Guide).