Perforomist

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Perforomist Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Formoterol (as fumarate) 20mcg/2mL; soln for inh.

    Pharmacological Class

    Long-acting beta-2 agonist (LABA).

    How Supplied

    Single-use vials (2mL)—30, 60

    How Supplied

    Perforomist Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. 

    Each vial is overwrapped in a foil pouch and supplied as:

    • Carton of 30 individually wrapped unit dose vials

    • Carton of 60 individually wrapped unit dose vials

    Storage

    Prior to dispensing to the patient: 

    Store in a refrigerator, 2° C to 8° C (36° F to 46° F). Protect pouch from light and heat.

    After dispensing to the patient: 

    Store in a refrigerator at 2° C to 8° C (36° F to 46° F) and discard when drug expires or store at room temperature, 20° C to 25° C (68° F to 77° F) and discard if not used after 3 months.

    Protect pouch from light and heat.

    Manufacturer

    Mylan Specialty L.P.

    Generic Availability

    YES

    Perforomist Indications

    Indications

    Long-term maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema.

    Limitations of Use

    Not indicated to treat acute deteriorations of COPD or for treatment of asthma.

    Limitations of Use Expanded

    The safety and effectiveness of formoterol inhalation solution in asthma have not been established.

    Perforomist Dosage and Administration

    Adult

    20mcg (1 vial) by nebulizer twice daily (AM & PM). Use standard jet nebulizer (eg, PARI-LC Plus [with face-mask or mouthpiece]) and air compressor (eg, Proneb Ultra compressor). Does not need to be diluted before nebulization. Do not mix with other drugs.

    Children

    Not established.

    Perforomist Contraindications

    Contraindications

    Use of LABA without inhaled corticosteroid (ICS) in asthma.

    Perforomist Boxed Warnings

    Not Applicable

    Perforomist Warnings/Precautions

    Warnings/Precautions

    LABA as monotherapy (without ICS) for asthma can increase risk of asthma-related events. Do not initiate in acute deteriorating COPD. Not for relief of acute symptoms. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Do not exceed recommended dose. Cardiovascular disease (esp. hypertension, coronary insufficiency, arrhythmias). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Pregnancy. Labor & delivery. Nursing mothers.

    Warnings/Precautions

    Long-acting beta2-adrenergic agonists (LABA) as monotherapy (without inhaled corticosteroids) for asthma can increase risk of asthma-related events: 

    • The increased risk of asthma-related death is considered a class effect of the LABA.

    • No study adequate to determine whether the rate of asthma-related death is increased in patients treated with formoterol inhalation solution has been conducted.

    • Available data do not suggest an increased risk of death with use of LABA in COPD patients.

    • Formoterol is not indicated for asthma.

    Do not initiate formoterol in patients with acutely deteriorating COPD; use in this setting is inappropriate.

    Not for relief of acute symptoms; acute symptoms should be treated with inhaled short-acting β2-agonist. Prescribe a short-acting β2-agonist for acute symptoms; monitor for increased need. Increasing inhaled β2-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 formoterol no longer controls the symptoms of bronchoconstriction, or the patient’s inhaled, short-acting β2-agonist becomes less effective or the patient needs more inhalation of short-acting β2-agonist than usual, these may be markers of deterioration of disease.

    Do not exceed the recommended dose. Fatalities have been reported with excessive use of inhaled sympathomimetic drugs. 

    Formorterol can produce paradoxical bronchospasm that may be life-threatening. Discontinue if paradoxical bronchospasm occurs and institute alternative therapy.

    Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension):

    • β2-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.

    • ECG changes have also been reported.

    • Use with caution in patients with cardiovascular disorders.

    • Consider discontinuing treatment if significant cardiovascular effects occur.

    Use with caution in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to sympathomimetic amines. Doses of the related β2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

    β-agonists may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. This is usually transient and does not require supplementation. β-agonists may produce transient hyperglycemia in some patients. Clinically significant changes in serum potassium and blood glucose were infrequent during clinical trials with long-term administration of formoterol at the recommended dose. 

    Pregnancy Considerations

    There is limited available data with formoterol inhalation solution use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. 

    No adequate and well-controlled studies in labor and delivery. Because of the potential for beta-agonist interference with uterine contractility, use of formoterol during labor should be restricted to whom the benefits clearly outweigh the risk.

    Nursing Mother Considerations

    There is no data on the presence of formoterol in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for formoterol and any potential adverse effects on the breastfed infant from formoterol or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness have not been established in pediatric patients.

    Geriatric Considerations

    No overall differences in safety or effectiveness were observed between geriatric patients (65 years and older) and younger patients. Greater sensitivity of some older individuals cannot be ruled out.

    Perforomist Pharmacokinetics

    Distribution

    The binding of formoterol to human plasma proteins in vitro was 61-64% at concentrations from 0.1-100 ng/mL.

    Metabolism

    Primarily by direct glucuronidation at either the phenolic or aliphatic hydroxyl group and O-demethylation followed by glucuronide conjugation at either phenolic hydroxyl groups. Minor pathways involve sulfate conjugation of formoterol and deformylation followed by sulfate conjugation. The most prominent pathway involves direct conjugation at the phenolic hydroxyl group. The second major pathway involves O-demethylation followed by conjugation at the phenolic 2'-hydroxyl group. 

    Elimination

    Renal. The mean terminal elimination half-life was determined to be 7 hours.

    Perforomist Interactions

    Interactions

    Caution with concomitant other adrenergic drugs; may potentiate sympathetic effects. Extreme caution with MAOIs, tricyclics, or others that prolong QTc interval (may cause ventricular arrhythmias). Antagonized by β-blockers. K+-depleting diuretics, xanthines, steroids may potentiate hypokalemia.

    Interactions

    Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in COPD patients. Therefore, patients with COPD should not normally be treated with beta-blockers. However, under certain circumstances, eg, as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

    Perforomist Adverse Reactions

    Adverse Reactions

    GI upset, nasopharyngitis, dry mouth, dizziness, insomnia; ECG changes or cardiovascular effects (eg, increased BP, tachycardia; consider discontinuing if occur); hypokalemia, hyperglycemia, metabolic acidosis; hypersensitivity reactions; rarely: paradoxical bronchospasm.

    Adverse Reactions

    Most common adverse reactions (≥2% and more common than placebo) are diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

    Beta2-agonist adverse reactions can include: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia.

    Perforomist Clinical Trials

    Clinical Trials

    Perforomist Inhalation Solution was evaluated in a 12-week, double-blind, placebo- and active-controlled, randomized, parallel-group, multicenter trial conducted in the US.

    Patient demographics: (N=351)

    • Age range: 40-86 years; mean age 63 years

    • Mean FEV1: 1.34L (44% of predicted)

    • 58% of patients had bronchodilator reversibility, defined as a 10% or greater increase in FEV1 after inhalation of 2 actuations (180mcg of albuterol from a metered dose inhaler)

    • About 86% (106) of patients treated with Perforomist and 74% (84) of placebo patients completed the trial

    Patients were randomly assigned to Perforomist 20 mcg (n=123) or placebo (n=114), administered twice daily via a PARI-LC Plus® nebulizer with a PRONEB® Ultra compressor.

    Perforomist 20mcg twice daily resulted in significantly greater post-dose bronchodilation (as measured by serial FEV1 for 12 hours post-dose; the primary efficacy analysis) compared to placebo when evaluated at endpoint (week 12 for completers and last observation for dropouts). Similar results were seen on Day 1 and at subsequent time points during the trial.

    Patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.

    Examination of age (≥65 or younger) and gender subgroups did not identify differences in response to Perforomist Inhalation Solution. There were too few non-Caucasian subjects to assess differences in populations defined by race adequately.

    In the 12-week study, 78% of patients achieved a 15% increase from baseline FEV1 after the first dose of Perforomist 20 mcg. The median time to onset of bronchodilation, defined as 15% increase in FEV1, was 11.7 minutes. Following dosing, the time to onset of bronchodilation was 13.1 minutes when defined as an increase in FEV1 of 12% and 200 mL. The median time to peak bronchodilator effect was 2 hours after dosing. 

    Perforomist Note

    Not Applicable

    Perforomist Patient Counseling

    Patient Counseling

    Serious Asthma-Related Events:

    • Long-acting beta agonist, such as formoterol, when used as monotherapy (without an inhaled corticosteroid), increases the risk of serious asthma-related events, including asthma-related death. 

    • Formoterol is not indicated for the treatment of asthma.

    Acute Exacerbations or Deteriorations:

    • Formoterol Inhalation Solution is not indicated for relief of acute symptoms, and extra doses should not be used for that purpose. 

    • Acute symptoms should be treated with an inhaled, short-acting beta2­ agonist.

    • Advise patients to seek medical attention if symptoms worsen despite recommended doses of formoterol, if formoterol treatment becomes less effective, or need more inhalations of a short-acting beta2-agonist than usual.

    Appropriate Dosing:

    • Do not stop using formoterol unless instructed to do so by a health care provider because symptoms may get worse. 

    • Do not inhale more than the prescribed number of vials at any one time. 

    • The daily dosage of formoterol solution should not exceed one vial twice daily (40 mcg total daily dose). 

    • Excessive use of sympathomimetics may cause significant cardiovascular effects and may be fatal.

    Concomitant Therapy:

    • If currently taking inhaled, short-acting beta2-agonists (eg, albuterol) on a regular basis, discontinue the regular use of these products and use them only for symptomatic relief of acute symptoms. 

    • Do not use formoterol with other inhaled medications containing long-acting beta2-agonists. 

    • Do not stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with formoterol.

    Cost Savings Program

    The Perforomist access and savings program are available here.

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