Arformoterol Tartrate

ARFORMOTEROL TARTRATE- arformoterol tartrate solution
Lupin Pharmaceuticals, Inc.

2 DOSAGE AND ADMINISTRATION

The recommended dose of Arformoterol Tartrate Inhalation Solution is one 15 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose of greater than 30 mcg (15 mcg twice daily) is not recommended.

Arformoterol Tartrate Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (see the accompanying Patient Information). Arformoterol Tartrate Inhalation Solution should not be swallowed.

Arformoterol Tartrate Inhalation Solution should be stored refrigerated in foil pouches. After opening the pouch, unused unit-dose vials should be returned to, and stored in, the pouch. An opened unit-dose vial should be used right away.

If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered.

No dose adjustment is required for patients with renal or hepatic impairment. However, since the clearance of Arformoterol Tartrate Inhalation Solution is prolonged in patients with hepatic impairment, they should be monitored closely.

The drug compatibility (physical and chemical), efficacy, and safety of Arformoterol Tartrate Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Arformoterol Tartrate Inhalation Solution have been established in clinical trials when administered using the PARI LC® Plus nebulizer (with a face mask or mouthpiece) and the PARI DURA NEB 3000 compressor. The safety and efficacy of Arformoterol Tartrate Inhalation Solution delivered from non-compressor based nebulizer systems have not been established.

3 DOSAGE FORMS AND STRENGTHS

Arformoterol Tartrate Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each 2 mL vial contains 15 mcg of arformoterol equivalent to 22 mcg of arformoterol tartrate.

4 CONTRAINDICATIONS

Arformoterol Tartrate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to arformoterol, racemic formoterol or to any other components of this product.

Use of a LABA, including Arformoterol Tartrate Inhalation Solution, without an inhaled cortisteroid is contraindicated in patients with asthma [see Warnings and Precautions (5) ]. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma.

5 WARNINGS AND PRECAUTIONS

5.1 Serious Asthma-Related Events — Hospitalizations, Intubations, Deaths

  • The safety and efficacy of Arformoterol Tartrate Inhalation Solution in patients with asthma have not been established. Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of asthma [see Contraindications (4) ].
  • Use of long-acting beta2 -adrenergic agonists (LABA) as monotherapy [without inhaled corticosteroids (ICS)] for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, and death) compared with ICS alone.
  • A 28-week, placebo-controlled US study comparing the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol (13/13,176 in patients treated with salmeterol vs. 3/13,179 in patients treated with placebo; RR 4.37, 95% CI 1.25, 15.34). The increased risk of asthma-related death is considered a class effect of the LABA, including Arformoterol Tartrate Inhalation Solution.
  • No study adequate to determine whether the rate of asthma-related death is increased in patients treated with Arformoterol Tartrate Inhalation Solution has been conducted. Clinical studies with racemic formoterol suggested a higher incidence of serious asthma exacerbations in patients who received racemic formoterol than in those who received placebo. The sizes of these studies were not adequate to precisely quantify the differences in serious asthma exacerbation rates between treatment groups.
  • Available data do not suggest an increased risk of death with use of LABA in patients with COPD.

5.2 Deterioration of Disease and Acute Episodes

Arformoterol Tartrate Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. The use of Arformoterol Tartrate Inhalation Solution in this setting is inappropriate.

Arformoterol Tartrate Inhalation Solution is not indicated for the treatment of acute episodes of bronchospasm, i.e., as rescue therapy and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled short-acting beta2 -agonist.

When beginning Arformoterol Tartrate Inhalation Solution, patients who have been taking inhaled short-acting beta2 -agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. When prescribing Arformoterol Tartrate Inhalation Solution, the healthcare provider should also prescribe an inhaled, short-acting beta2 -agonist and instruct the patient how it should be used. Increasing inhaled beta2 -agonist use is a signal of deteriorating disease for which prompt medical attention is indicated. COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If Arformoterol Tartrate Inhalation Solution no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting beta2 -agonist becomes less effective or the patient needs more inhalation of short-acting beta2 -agonist than usual, these may be markers of deterioration of disease. In this setting, a reevaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dosage of Arformoterol Tartrate Inhalation Solution beyond the recommended 15 mcg twice daily dose is not appropriate in this situation.

5.3 Excessive Use of Arformoterol Tartrate Inhalation Solution and Use with Other Long- Acting Beta2 -Agonists

Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. As with other inhaled beta2 -adrenergic drugs, Arformoterol Tartrate Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other medications containing long-acting beta2 -agonists.

5.4 Paradoxical Bronchospasm

As with other inhaled beta2 -agonists, Arformoterol Tartrate Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, Arformoterol Tartrate Inhalation Solution should be discontinued immediately and alternative therapy instituted.

5.5 Cardiovascular Effects

Arformoterol Tartrate Inhalation Solution, like other beta2 -agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. In addition, beta-agonists have 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. Arformoterol Tartrate Inhalation Solution, as with other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

5.6 Coexisting Conditions

Arformoterol Tartrate Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. In two pooled, 12-week, placebo-controlled trials investigating Arformoterol Tartrate Inhalation Solution doses of 15 μg BID, 25 μg BID, and 50 μg QD, changes in mean predose and 2-hour post dose systolic and/or diastolic blood pressure were seen as a general fall of 2 — 4 mm/Hg; for pulse rate the mean of maximal increases were 8.8 to 12.0 beats/min. Over the course of a one- year study measuring serial electrocardiograms while receiving a dose of 50 mcg daily of Arformoterol Tartrate Inhalation Solution resulted in an approximately 3.0 ms increase in QTC-F compared to the active comparator, salmeterol. Doses of the related beta2 -agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

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