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PERFOROMIST® FAQs

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.

Like many other patients with COPD who have been prescribed a new medication, you may still have questions about PERFOROMIST. For your convenience, answers to many of these "frequently asked questions" are provided here. However, your doctor is your best source of information.

Frequently asked questions about PERFOROMIST

Q. What is PERFOROMIST?

A. PERFOROMIST is an FDA-approved inhalation solution that is used with a nebulizer. A nebulizer is a device that converts liquid medication into a fine mist that you inhale through a mouthpiece or facemask. You can treat your COPD by taking PERFOROMIST twice daily—once in the morning and once in the evening.1

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Q. Is PERFOROMIST the right COPD therapy for me?

A. The decision of whether or not to take PERFOROMIST is up to you and your doctor. PERFOROMIST is taken twice a day—once in the morning and once in the evening. You insert the medication into a nebulizer, place your lips over the mouthpiece (or use a mask), and breathe naturally.

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Q. Is a nebulizer right for me?

Some people find the handheld devices to be more convenient. However, if you can't use these inhalers correctly, you may not get the full benefit of the medicine. With a metered-dose inhaler (MDI) or dry-powder inhaler (DPI), you must coordinate your breathing with the mechanics of the inhaler. This can be tricky if you have arthritis, find the use of hand held inhalers confusing, or are unable to take a full deep breath or simply breathe in too soon or too late. Your doctor can help you decide which device is right for your COPD therapy.

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Q. What common side effects do people experience with PERFOROMIST?

A. In a study, the most common side effects seen with PERFOROMIST were: diarrhea, nausea, upper airway irritation, dry mouth, vomiting, dizziness and insomnia (inability to sleep). These side effects occurred in 5% or fewer of people taking PERFOROMIST. Similar side effects also occurred in people taking a placebo (a harmless inactive substance that contains no medicine).1

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Q: Does PERFOROMIST affect the heart?

A. In the clinical trial for PERFOROMIST, cardiovascular (heart-related) side effects occurred in less than 1% of participants and were similar to placebo.*1

However, beta2-agonists like PERFOROMIST can produce a cardiovascular effect in some patients, including effects such as increased pulse rate or blood pressure. If these effects occur, your doctor may decide to have you stop taking PERFOROMIST. If you already have a cardiovascular disorder, your doctor will monitor your heart health carefully while you are taking PERFOROMIST.1

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Q. What drug interactions do I need to be aware of with PERFOROMIST?

A. Your doctor will advise you whether or not to continue taking your current inhalers for COPD. You should not use other medicines that include a long-acting beta2-agonist while taking PERFOROMIST.1 You should also only use a short-acting beta2-agonist (SABA) "as needed" for rescue situations (sudden episodes of shortness of breath) while taking PERFOROMIST.

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

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Q. Is PERFOROMIST covered by Medicare?

A. Yes. As a nebulized medication it is eligible for Medicare reimbursement. Medicare Part B may reimburse much of the cost of your PERFOROMIST prescription if you are 65 or older. In certain situations, Medicare Part D may also reimburse much of the cost.

If you are unable to afford the cost of your medications, Medicaid may also reimburse much of the cost. You may qualify for Medicaid if you have a limited income; this program includes certain adults, the disabled and the elderly.35,36

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Q. Where do I get PERFOROMIST and a nebulizer?

A. Many people get their PERFOROMIST and nebulizer system at a pharmacy. Others (who qualify), have it delivered to their home through the Medicare Part B Home Health Benefit; read more here. You may want to call your insurance company to see what costs are covered.

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Q. Will PERFOROMIST cure my COPD?

A. No. There is no cure for COPD at this time. But PERFOROMIST may help you manage your COPD. PERFOROMIST has been proven to improve lung function, which should help you breathe easier.1

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Q. How often do I take PERFOROMIST?

A. PERFOROMIST is taken two times a day (morning and evening).1

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Q. How long after taking PERFOROMIST will I get relief?

A. PERFOROMIST can start working in as little as five minutes. But the response time will vary from patient to patient.2 You should never take PERFOROMIST to treat sudden symptoms or use it more often than directed. Every patient with COPD should have a fast-acting medication like albuterol available to treat sudden symptoms.1

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Q. How long does PERFOROMIST last?

A. One dose of PERFOROMIST can provide relief for up to 12 hours.1

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*In the clinical study, significant cardiac adverse events were similar to placebo over 12 weeks. The study was not designed to compare side effects between the 2 groups. The study excluded patients with severe cardiac abnormalities. PERFOROMIST, like other beta2-agonists, can produce a cardiovascular effect in some patients, as measured by increased pulse rate, blood pressure and/or symptoms.13

Next topic: Home Health Care Eligibility

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. U.S. Department of Health and Human Services/NIH. Living with COPD. Available at: http://www.nhlbi.nih.gov/health/dci/Diseases/Copd/Copd_LivingWith.html. Access July 13, 2011.
  13. 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].
  14. Proventil HFA Prescribing Information. Kenilworth, NJ: Schering-Plough. 1998.
  15. Atrovent HFA Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2010.
  16. Combivent Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. September 2010.
  17. Spiriva HandiHaler Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. and New York, NY: Pfizer Inc. 2010.
  18. Dolovich MB, Ahrens RC, Hess DR, et al. Device selection and outcomes of aerosol treatment: evidence-based guidelines. Chest. 2005;127(1):335-371.
  19. Theophylline extended-release tablets prescribing information. Kansas City, MO: Nostrum Laboratories, Inc. May 2009.
  20. Pari Trek S Compact Compressor Nebulizer System. Instructions for use. Revised 2006.
  21. Geller DE. Comparing clinical features of the nebulizer, metered-dose inhaler, and dry powder inhaler. Respir Care. 2005;50:1313-1321.
  22. Advair HFA Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2011.
  23. 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.
  24. 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.
  25. Data on file. Survey conducted by KRC Research: COPD Patient and Caregiver Studies, March 2009. Dey Pharma, LP.
  26. Advair Diskus Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2011.
  27. Pulmicort Flexhaler Prescribing Information. Södertälje, Sweden: AstraZeneca. 2010.
  28. 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.
  29. American Lung Association of Minnesota/Minnesota COPD Coalition/NCQA Certified Disease Management. Understanding & managing your chronic obstructive pulmonary disease (COPD) brochure. 09/07.
  30. Ventolin HFA Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2009.
  31. 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.
  32. 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
  33. 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.
  34. Symbicort Prescribing Information. Dunkerque, France: AstraZeneca. 2010.
  35. Centers for Medicare & Medicaid Services. Department of Health and Human Services, USA. Medicare and Home Health Care. Available at: www.medicare.gov.
  36. 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.