LISTEN TO more than just THEIR LUNGS

Your patients with COPD might be asking for PERFOROMIST.

Indication

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD

  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

Efficacy and Safety

Help your COPD patients breathe easier

Nebulized PERFOROMIST:

In a 12 week clinical trial N=351 in COPD patients. PERFOROMIST: Sustained FEV1 improvement up to 12 hours from baseline to end of study.2,4

  • Provides rapid onset of bronchodilation that lasts for up to 12 hours2
    • Works in as soon as 5 minutes4. The median time to onset of bronchodilation was 11.7 minutes defined as a 15% increase in FEV1.2
    • 78% of patients achieved a 15% increase from baseline FEV1 following the first dose of PERFOROMIST Inhalation Solution2
  • Doesn't require hand-breath coordination; normal tidal breathing is sufficient for proper dosing.2,5
  • No evidence of tachyphylaxis was observed as indicated by maintained FEV1 AUC treatment as observed up to 12-weeks.2,4
    • Tolerance to the effects of inhaled beta-agonists can occur with regularly scheduled, chronic use.2
  • Can be stored at room temperature for up to three months—longer than any other nebulized long-acting
    beta2-agonist.2

PERFOROMIST Inhalation Solution 20 mcg 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. Sustained and consistent bronchodilation was observed at each timepoint measured throughout the study period2

PERFOROMIST Most Common Adverse Events in Clinical Trials

Incidence of adverse events with PERFOROMIST in ≥2% of patients was similar to that of placebo, with no reports of tremor.2,7

Adverse event2,4* n PERFOROMIST
Inhalation
Solution
20 mcg
n Placebo
Total Patients 123 (100) 114 (100)
Diarrhea 6 5% 4 4%
Nausea 6 5% 3 3%
Nasopharyngitis 4 3% 2 2%
Dry mouth 4 3% 2 2%
Vomiting 3 2% 2 2%
Dizziness 3 2% 1 1%
Insomnia 3 2% 0 0%

*The most common adverse events (reported in ≥2% of patients and occurring more frequently than with placebo).2

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Impact on COPD Rescue Therapy

PERFOROMIST reduced rescue therapy use by 42% (-1.25 puffs/day).2,4

In a clinical trial, nebulized PERFOROMIST reduced rescue inhaler use by up to 42% (-1.25 puffs a day). In a 12-week study, patients treated with PERFOROMIST Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.2,4

Average daily albuterol usage (puffs) over 12-week study2,4

A randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group study in 351 moderate to severe COPD patients evaluating the safety and efficacy of PERFOROMIST Inhalation Solution (20 mcg/2 mL BID) over 12 weeks.2

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Choosing PERFOROMIST For Your Patients

Which Patients May Benefit From a Nebulized LABA Maintenance Treatment?

Nebulization can be used across various patient care settings, including home, long-term care and hospital. 5,8

Some patients may have difficulty correctly using their inhaler devices, and, as a result, for these patients maintenance treatment of COPD with a nebulized LABA may be an option.5,8

Here are some of the patient types who may be candidates for a nebulized LABA:

  • Patients with diminished inspiratory capacity (difficulty taking deep breaths)
  • Patients who may have difficulty with hand-breath coordination.5,8
  • Patients on a nebulized SABA who are candidates for a maintenance treatment1

Nebulized LABAs in the Hospital Setting

Evolving U.S. health care delivery systems are impacting how chronic diseases, such as COPD, are managed in the hospital setting.

  • For Medicare patients ages 65+, chronic obstructive pulmonary disease (COPD) and bronchiectasis are the fourth leading causes of hospital readmissions.9
  • 21.5% of COPD and bronchiectasis patients are rehospitalized within 30 days.9
    The number of hospitalizations and emergency department visits increased over the past decade.10 To help improve these rates, the Centers for Medicare & Medicaid Services (CMS) is implementing policy changes for 2016 rates.11
  • CMS is now required to publicly report readmission rates.11
  • There may be penalties, such as lower Medicare reimbursements, associated with excessive 30-day readmission rates for acute exacerbations of COPD.11
    Penalties have already been imposed for above-average readmission rates for chronic conditions such as heart failure, acute myocardial infarction, and pneumonia.11
  • Inefficiency is penalized based on the Pay For Performance program.11
  • Discharge planning can be an effective tool in reducing some COPD readmissions.1
      — Consider whether nebulized therapy may be suitable for patients transitioning from the hospital setting.1

PERFOROMIST is not indicated to treat acute deteriorations of COPD.2

The impact of PERFOROMIST on hospital readmission rates has not been evaluated.

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Coverage and Reimbursement

PERFOROMIST Offers Broad Coverage2*

Nebulized PERFOROMIST is covered under Medicare Parts B and most Part D plans.12-17

How to submit prescriptions for PERFOROMIST® Inhalation Solution in three steps...

Step 1

Ask your Mylan representative to help locate participating retail and home health care pharmacies in your area.

Step 2


For a Retail Pharmacy:

  • Write a prescription for your patient to submit to the pharmacy, making sure to include:
    • Dosing instructions
    • The appropriate ICD-9 diagnosis codes, which could include, for example:
      • COPD: 49618
      • Chronic bronchitis: 491.0-491.919
      • Emphysema: 492.0, 492.820
    • Confirmation that the patient meets Medicare coverage criteria

For Home Health Care:

  • Complete and fax the COPD Prescription Form to the home health care pharmacy. Make sure to include:
    • All patient information
    • The appropriate ICD-9 diagnosis codes, which could include, for example:
      • COPD: 49618
      • Chronic bronchitis: 491.0-491.919
      • Emphysema: 492.0, 492.820
    • A statement that captures the medical necessity for continued use for PERFOROMIST
    • Confirmation that the patient meets Medicare coverage criteria

COPD Prescription Form is available from your Mylan representative.

Step 3


For a Retail Pharmacy:

  • Direct patient to submit the prescription to the pharmacy
    • Be sure to remind your patient to bring primary and supplemental insurance documents to the pharmacy

For Home Health Care:

  • Fax the completed form to the home health care pharmacy

*PERFOROMIST is covered by 79% of commercial plans, a majority without prior therapy restrictions.2 Plus, for
long-term care, PERFOROMIST is covered by Medicare Part D without prior therapy restrictions for more than 65% of Medicare patients.2

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WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST® Inhalation Solution.

The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication.

Indication

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD
  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

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

PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

PERFOROMIST Inhalation Solution 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.

PERFOROMIST 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.

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

PERFOROMIST Inhalation Solution, as with other beta2-agonists, should be used with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

References
  1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of COPD. http://www.goldcopd.org/Guidelines/guidelines-resources.html. Updated 2014. Accessed Feb 22, 2014.
  2. PERFOROMIST® (formoterol fumarate) Inhalation Solution Prescribing Information. Mylan Specialty L.P.; January 2013.
  3. Data on file 2013 (data current as of May 22, 2014), Mylan Specialty L.P., 2012.
  4. Gross NJ. Nelson HS, Lapidus RJ, et al; for the Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008;102(2): 189-197.
  5. Sims MW. Aerosol therapy for obstructive lung diseases: device selection and practice management issues. Chest. 2011; 140(3):781-788.
  6. Nelson HS, Weiss ST, Bleecker ER, et al. The salmeterol multicenter asthma research trial. Chest. 2006; 129(1)
  7. Hanania NA, Boota A, Kerwin E, Tomlinson L, Denis-Mize K. Efficacy and safety of nebulized formoterol as add-on therapy in COPD patients receiving maintenance tiotropium bromide: results from a 6-week, randomized, placebo-controlled, clinical trial. Drugs. 2009;69(9):1205-1216.
  8. Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol therapy: evidence-based guidelines. Chest. 2005; 127(1):335-371.
  9. Hines AL, Barrett ML, Jiang HJ, Steiner CA. Conditions With the Largest Number of Adult Hospital Readmissions by Payer, 2011. HCUP Statistical Brief #172. April 2014. Agency for Healthcare Research and Quality, Rockville, MD.
  10. Ford Earl S. Hospital discharges, readmissions, and emergency department visits for chronic obstructive pulmonary disease or bronchiectasis among US adults: findings from the Nationwide Inpatient Sample 2001-2012 and Nationwide Emergency Department Sample 2006-2011. Chest. Accessed Nov. 11, 2014.
  11. Medicare Payment Advisory Commission. Report to the Congress: Medicare payment policy. http://www.medpac.gov/documents/Mar13_EntireReport.pdf. Published March 2013. Accessed April 8, 2013.
  12. Medicare.gov. Your Medicare coverage. http://www.medicare.gov/coverage/prescription-drugs-outpatient-limited-coverage.html. Accessed May 5, 2014.
  13. American Medical Association. NHIC, Corp.: A CMS Contractor; Centers for Medicare & Medicaid Services. Local coverage determination (LCD) for nebulizers (L11499). http://www.medicarenhic.com/viewdoc.aspx?id=2474. Revised November 8, 2013. Accessed February 10, 2013
  14. American Medical Association. CMS Contractor: CGS Administrators, LLC. Medicare guidelines for coverage. Local coverage determination (LCD) for nebulizers (L5007). http://www.ppsc.com/MedicareGuidelines/LCDs/Neb%20MCR%20C%20LCD%20L5007%2008.05.11.pdf. Revised August 5, 2011. Accessed February 10, 2013.
  15. American Medical Association. CMS Contractor: Noridian Administrative Services, LLC.; Centers for Medicare & Medicaid Services. Local coverage determination (LCD) for nebulizers (L11488). 2013. https://www.noridianmedicare.com/dme/coverage/docs/lcds/current/nebulizers.htm. Accessed May 5, 2014
  16. American Medical Association. CMS Contractor: National Government Services, Inc. Medicare guidelines for coverage. LCD for nebulizers (L27226). http://www.ppsc.com/MedicareGuidelines/LCDs/Neb%20MCR%20B%20LCD%20L27226%2001.01.10.pdf
  17. Centers for Medicare & Medicaid Services. 2010 Medicare prescription drug benefit manual. https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/downloads/Chapter6.pdf Revised February 19, 2010. Current as of August 14, 2014.
  18. 2014 ICD-9-CM diagnosis code 496: chronic airway obstruction. http://www.icd9data.com/2014/Volume1/460-519/490-496/496/496.htm. Current as of May 5, 2014.
  19. 2014 ICD-9-CM diagnosis code 491: chronic bronchitis. http://www.icd9data.com/2014/Volume1/460-519/490-496/491/default.htm. Current as of May 5, 2014.
  20. 2014 ICD-9-CM diagnosis code 492: emphysema. http://www.icd9data.com/2014/Volume1/460-519/490-496/492/default.htm. Current as of May 5, 2014.

Perforomist® is a registered trademark of Mylan Inc. licensed exclusively to its wholly-owned subsidiary,
Mylan Specialty L.P. © 2014 Mylan Specialty L.P. All rights reserved. 11/14 PER-2014-0095

SEE MORE

Prescribing Information

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST® Inhalation Solution.

The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication.

Indication

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD.
  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

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

PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

PERFOROMIST Inhalation Solution 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.

PERFOROMIST 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.

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

PERFOROMIST Inhalation Solution, as with other beta2-agonists, should be used with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.