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Patient Counseling Information

See USPI and Medication Guide

Asthma-Related Death

Note: The safety and efficacy of PERFOROMIST® in patients with asthma have not been established.

See Medication Guide
Patients should be informed that long acting beta agonist, such as PERFOROMIST, increase the risk of asthma-related death. All LABA, including PERFOROMIST, should not be used in patients with asthma without use of a long-term asthma control medication. See Warnings and Precautions Section 5.1 of the full Prescribing Information.

Acute Exacerbations or Deteriorations

PERFOROMIST 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 (the healthcare provider should provide the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen despite recommended doses of PERFOROMIST Inhalation Solution, if PERFOROMIST Inhalation Solution treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual. See Warnings and Precautions Section 5.2 of the full Prescribing Information.

Appropriate Dosing

Patients should not stop using PERFOROMIST Inhalation Solution unless told to do so by a healthcare provider because symptoms may get worse. Patients should not inhale more than the prescribed number of vials at any one time. The daily dosage of PERFOROMIST Inhalation 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. See Dosage and Administration Section 2 of the full Prescribing Information.

Concomitant Therapy

Patients who have been taking inhaled, short-acting beta2-agonists (e.g., albuterol) on a regular basis should be instructed to discontinue the regular use of these products and use them only for symptomatic relief of acute symptoms. PERFOROMIST Inhalation Solution should not be used in conjunction with other inhaled medications containing long-acting beta2-agonists. Patients should be warned not to stop or change the dose of other concomitant COPD therapy without medical advice, even if symptoms improve after initiating treatment with PERFOROMIST Inhalation Solution.

Common Adverse Reactions with Beta2-agonists

Patients should be informed that treatment with beta2-agonists may lead to adverse reactions that include palpitations, chest pain, rapid heart rate, increased or decreased blood pressure, headache, tremor, nervousness, dry mouth, muscle cramps, nausea, dizziness, fatigue, malaise, low blood potassium, high blood sugar, high blood acid, or trouble sleeping . See Adverse Reactions Section 6.1 of the full Prescribing Information.

Instructions for Administration

It is important that patients understand how to use PERFOROMIST Inhalation Solution with a nebulizer appropriately [see Medication Guide]. Patients should be instructed not to mix other medications with PERFOROMIST Inhalation Solution or ingest PERFOROMIST Inhalation Solution. Patients should throw the plastic dispensing container away immediately after use. Due to their small size, the container and top pose a danger of choking to young children.

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.
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  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.
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  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.
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  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.
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  30. Ventolin HFA Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. 2009.
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  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.
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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.