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Important Safety Information

Doctor Discussion Guide for Patients with COPD Talking with your doctor about your COPD treatment can be difficult. Use this guide to prepare for a conversation with your doctor. Make a plan.
About PERFOROMIST PERFOROMIST works all day to help you breathe easier and get back to doing some of the things you enjoy doing.15,21 Learn more.
Benefits of PERFOROMIST In studies, PERFOROMIST reduced patient use of rescue albuterol.21 Get the facts.

Indication

PERFOROMIST (formoterol fumarate) Inhalation Solution is used for the long-term treatment of chronic obstructive pulmonary disease (COPD) including chronic inflammation of the lungs (bronchitis) and emphysema. It is only to be used with a nebulizer and is taken twice daily (morning and evening).

WARNING: ASTHMA-RELATED DEATH

PERFOROMIST Inhalation Solution belongs to a class of drugs called long-acting beta2-agonists (LABA). People with asthma who take LABA such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems. Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
PERFOROMIST Inhalation Solution should not be used instead of rescue inhaler or nebulized medicine for the treatment of acute symptoms. Extra doses of PERFOROMIST Inhalation Solution should not be used for that purpose since overuse can cause serious heart problems, including death. Acute or sudden symptoms should be treated with an inhaled short-acting beta2-agonist. Seek immediate medical attention if:

  • your symptoms quickly worsen despite recommended doses of PERFOROMIST Inhalation Solution
  • PERFOROMIST Inhalation Solution treatment becomes less effective
  • you need more inhalations of a short-acting beta2-agonist (rescue inhaler or nebulized medicine) than usual.

Do not use PERFOROMIST Inhalation Solution with other LABA medicines for any reason.

How to Use PERFOROMIST Inhalation Solution
Use PERFOROMIST Inhalation Solution exactly as directed by your health care professional. Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your health care professional because your symptoms might get worse. Your health care professional will change your medicines as needed.

Co-existing Conditions
The use of PERFOROMIST Inhalation Solution with certain health conditions or with certain medications can cause serious side effects. Tell your health care professional about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Drug Interactions
Tell your health care professional about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain other medicines may interact with each other and cause serious side effects.

Side Effects
The most common side effects reported in patients taking PERFOROMIST Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, dizziness, and insomnia. Serious side effects may include sudden shortness of breath, serious allergic reactions, chest pain, increased or decreased blood pressure, a fast and irregular heartbeat, low blood potassium, high blood sugar, and high blood acid.

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.

Some Topics for Discussion with Your Doctor

Taking PERFOROMIST with Other Medications

You may be taking other medications or trying other forms of COPD treatment. You may also be taking medications for other unrelated conditions, like high blood pressure. Make sure everyone on your health care team, including your pharmacist, has a full list of all medications you are taking.1 To read more about getting the best results from PERFOROMIST, click here.

There are some medications your doctor needs to know about because they may interact with PERFOROMIST (they either may cause side effects or cause side effects to worsen, or may make one of the two drugs less effective). These may include adrenergic drugs (for example, adrenaline), some types of diuretics (used commonly for blood pressure and other indications), tricyclic antidepressants, beta-blockers (for high blood pressure) and other drugs.1,22 So, be sure to review all medications you are taking with your doctor.

What About Using My Other Inhalers While Taking PERFOROMIST?

Your doctor will determine what combination of medicines is right for the treatment of your COPD symptoms.

If you are taking PERFOROMIST, you should not use other medications that contain a long-acting beta2-agonist (LABA). Read more about LABAs here.1

When taking PERFOROMIST, you should only use a short-acting beta2-agonist (SABA) "as needed" for rescue situations (sudden episodes of shortness of breath). PERFOROMIST is not a rescue medication, so you should continue to follow your doctor's instructions regarding when and how often to use your rescue inhaler. Read more about rescue medications here.1

If you have concerns, talk to your doctor.

Stopping Your COPD Treatment

  • Do not stop taking PERFOROMIST because you are breathing better.1
    • If you are breathing better, that means PERFOROMIST is working. PERFOROMIST is a medication that works because you take it twice-daily over time.
    • Stopping PERFOROMIST could cause your symptoms to get worse.
  • If you have any safety concerns, talk to your doctor.

PERFOROMIST is Not a "Rescue" Medication

  • Remember, PERFOROMIST is not a "rescue" medication and should not be used for sudden episodes of shortness of breath1
  • PERFOROMIST should not be used for patients with quickly deteriorating COPD1

Talk to Your Doctor if You Have Any Concerns

  • Do not stop taking PERFOROMIST unless told to do so by your doctor because your symptoms may get worse.
  • If symptoms do get worse while taking PERFOROMIST, do not take more medication than prescribed; instead, call your doctor.

Next topic: Taking PERFOROMIST

References

  1. PERFOROMIST Prescribing Information. Napa, CA: Dey Pharma, L.P. 2010.
  2. Gross NJ, Nelson HS, Lapidus RJ, et al; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008;102(2):189-197.
  3. Mannino DM et al. MMWR Surveill Summ. 2002;51:1-13.
  4. National Institutes of Health/U.S. Department of Health & Human Services. National Heart Lung and Blood Institute Diseases and Conditions Index. What is COPD? Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_WhatIs.html. Accessed July 13, 2011.
  5. Rodriguez-Roisin R, Anzueto A, Bourbeau J, et al; GOLD Executive Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (updated 2009). Global Initiative for Chronic Obstructive Lung Disease website: http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Accessed March 8, 2010.
  6. National Heart Lung and Blood Institute: National Institutes of Health. When you are diagnosed with COPD. Available at: http://www.nhlbi.nih.gov/health/public/lung/copd/breathing-better/taking-action.htm. Accessed July 13, 2011.
  7. American Lung Association. Living with COPD: a life change. Available at: http://www.lungusa.org/lung-disease/copd/living-with-copd/life-change.html. Accessed July 13, 2011.
  8. CDC FastStats: Chronic Obstructive Pulmonary Disease (COPD) Includes: Chronic Bronchitis and Emphysema. Available at: http://www.cdc.gov/nchs/fastats/copd.htm. Accessed April 11, 2011.
  9. CDC Vital and Health Statistics. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2009. Hyattsville, Maryland. 8/2010.
  10. U.S. Department of Health and Human Services. Caregiver tip sheet. Available at: http://www.strokecamp.com/content/resourcesCAR/CaregiverTipSheet.pdf. Accessed on July 13, 2011.
  11. Data on file. Evaluation of concepts for Perforomist. Dey #0257 Final research report (market research). LinguiSearch. March 23, 2011.
  12. Nelson HS, Gross NJ, Levine B, et al. Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, ranodmized, double-blind, double-dummy, placebo- and active-controlled trial [published correction appears in Clin Ther. 2009;31(4):920].
  13. Proventil HFA Prescribing Information. Kenilworth, NJ: Schering-Plough. 1998.
  14. Atrovent HFA Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2010.
  15. Combivent Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. September 2010.
  16. Spiriva HandiHaler Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. and New York, NY: Pfizer Inc. 2010.
  17. Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol treatment: evidence-based guidelines. Chest. 2005;127(1):335-371.
  18. Theophylline extended-release tablets prescribing information. Kansas City, MO: Nostrum Laboratories, Inc. May 2009.
  19. Pari Trek S Compact Compressor Nebulizer System. Instructions for use. Revised 2006.
  20. Geller DE. Comparing clinical features of the nebulizer, metered-dose inhaler, and dry powder inhaler. Respir Care. 2005;50:1313-1321.
  21. Advair HFA Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2011.
  22. Press VG, Arora VM, Shah LM, et al. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD. J Gen Intern Med. In press.
  23. Van der Palen J, Klein JJ, Kerkhoff AH, van Herwaarden CL, Seydel ER. Evaluation of the long-term effectiveness of three instruction modes for inhaling medicines. Pt Ed Couns. 1997;32:S87-S95.
  24. Data on file. Survey conducted by KRC Research: COPD Patient and Caregiver Studies, March 2009. Dey Pharma, LP.
  25. Advair Diskus Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2011.
  26. Pulmicort Flexhaler Prescribing Information. Södertälje, Sweden: AstraZeneca. 2010.
  27. Mayo Clinic. Asthma inhalers: which one’s right for you? Available at: http://www.mayoclinic.com/health/asthma-inhalers/HQ01081/METHOD=print. Accessed August 22, 2011.
  28. American Lung Association of Minnesota/Minnesota COPD Coalition/NCQA Certified Disease Management. Understanding & managing your chronic obstructive pulmonary disease (COPD) brochure. 09/07.
  29. Ventolin HFA Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2009.
  30. American Lung Association. My COPD Action Plan. Available at: http://www.lungusa.org/lung-disease/copd/living-with-copd/copd-management-tools.html. Accessed August 22, 2011.
  31. American Thoracic Society. Standards for the Diagnosis and Care of Patients with Chronic Obstructive Pulmonary Disease. American Journal of Respiratory and Critical Care Medicine. 1995;152:S77-S120
  32. National Heart, Lung, and Blood Institute: National Institutes of Health. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report 2007.
  33. Symbicort Prescribing Information. Dunkerque, France: AstraZeneca. 2010.
  34. Centers for Medicare & Medicaid Services. Department of Health and Human Services, USA. Medicare and Home Health Care. Available at: www.medicare.gov.
  35. Centers for Medicare & Medicaid Services. Medicaid Program—General Information: Overview. Available at: www.cms.gov/MedicaidGenInfo/. Accessed June 23, 2011.

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

Indication

PERFOROMIST (formoterol fumarate) Inhalation Solution is used for the long-term treatment of chronic obstructive pulmonary disease (COPD) including chronic inflammation of the lungs (bronchitis) and emphysema. It is only to be used with a nebulizer and is taken twice daily (morning and evening).

WARNING: ASTHMA-RELATED DEATH

PERFOROMIST Inhalation Solution belongs to a class of drugs called long-acting beta2-agonists (LABA). People with asthma who take LABA such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems. Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions
PERFOROMIST Inhalation Solution should not be used instead of rescue inhaler or nebulized medicine for the treatment of acute symptoms. Extra doses of PERFOROMIST Inhalation Solution should not be used for that purpose since overuse can cause serious heart problems, including death. Acute or sudden symptoms should be treated with an inhaled short-acting beta2-agonist. Seek immediate medical attention if:

  • your symptoms quickly worsen despite recommended doses of PERFOROMIST Inhalation Solution
  • PERFOROMIST Inhalation Solution treatment becomes less effective
  • you need more inhalations of a short-acting beta2-agonist (rescue inhaler or nebulized medicine) than usual.

Do not use PERFOROMIST Inhalation Solution with other LABA medicines for any reason.

How to Use PERFOROMIST Inhalation Solution
Use PERFOROMIST Inhalation Solution exactly as directed by your health care professional. Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your health care professional because your symptoms might get worse. Your health care professional will change your medicines as needed.

Co-existing Conditions
The use of PERFOROMIST Inhalation Solution with certain health conditions or with certain medications can cause serious side effects. Tell your health care professional about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Drug Interactions
Tell your health care professional about all the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain other medicines may interact with each other and cause serious side effects.

Side Effects
The most common side effects reported in patients taking PERFOROMIST Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, dizziness, and insomnia. Serious side effects may include sudden shortness of breath, serious allergic reactions, chest pain, increased or decreased blood pressure, a fast and irregular heartbeat, low blood potassium, high blood sugar, and high blood acid.

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.