Pharmaceutical Approval Update: Arformoterol Tartrate Inhalation Solution (Brovana)

29 Mar

Arformoterol Tartrate Inhalation Solution (Brovana)

Manufacturer: Sepracor, Inc., Marlborough, MA

Indication: Arformoterol solution is indicated for the long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function.

Arformoterol is intended for use with a nebulizer only.

Drug Class: As a single isomer of formoterol (Foradil Aerolizer, Schering) arformoterol is the first long-acting beta2-adrenergic agonist bronchodilator to be developed in an inhalation solution. The agent’s molecular weight is 494.5 g/mol, and its empirical formula is C19H24N2O4 • C4H6O6 (1:1 salt).  canadian antibiotics

Uniqueness of Drug: Arformoterol is the first drug in its class to be approved as an inhalation solution for use with a nebulizer, a machine that converts liquid medication into a mist that is inhaled through a mouthpiece or mask.

Boxed Warning: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. A large placebo-controlled U.S. study compared the safety of another long-acting beta2-adrenergic agonist, salmeterol xinafoate (Ser-event, GlaxoSmithKline), or placebo. When added to usual asthma therapy, salmeterol resulted in an increase in asthma-related deaths in the patients receiving it. This finding may apply to arformoterol.

Warnings: The risk of asthma-related death may be increased with long-acting beta2-adrenergic agonists. Data are not available to determine whether the death rate in patients with COPD is increased by long-acting beta2-adrenergic agonists.

Patients who have been taking inhaled, short-acting beta2-agonists on a regular basis (e.g., four times daily) should discontinue the routine use of these drugs and should use them only for symptomatic relief of acute respiratory symptoms.
As with other inhaled beta2-agonists, arformoterol can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, arformoterol should be discontinued immediately and alternative therapy should be instituted.

Like other beta2-agonists, arformoterol can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate or blood pressure. Even though such effects are uncommon after administration of arformoterol at the recommended dose, the drug may need to be discontinued if these effects occur.

Beta-agonists have also been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST-segment depression. The clinical significance of these findings is unknown.

As with other sympathomimetic amines, arformoterol should be used with caution in the following circumstances:

  • patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • patients with convulsive disorders or thyrotoxicosis
  • patients who are unusually responsive to sympatho-mimetic amines

Contraindications: Arformoterol is not indicated for patients with acute episodes of bronchospasm (as rescue therapy) or for patients with acutely deteriorating COPD, which may be a life-threatening condition.
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It should not be used in conjunction with other inhaled, long-acting beta2-agonists or with other medications containing long-acting beta2-agonists when patients are beginning treatment.

This product should not be prescribed for children.

Dosage and Administration: Arformoterol tartrate inhalation solution 15 mcg is administered twice daily (in the morning and evening) by nebulization as maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema.

Commentary: COPD is the fourth leading cause of death in the U.S. In 2004, approximately 12 million adults in the U.S. were reported to have COPD. Mortality rates for COPD have been increasing and are expected to continue to rise. buy tadacip

Patients who need nebulized treatment may benefit from the rapid and sustained bronchodilation that arformoterol, a long-term maintenance treatment, can provide. With the approval of this product, health care providers have a new choice in the treatment arsenal for COPD that may offer an effective and a safe way to manage bronchoconstriction associated with this disease. However, arformoterol has not been shown to have an impact on the progression of disease or survival of patients with COPD.