Perforomist Inhalation Solution

Generic Name: formoterol fumarate
Date of Approval: May 11, 2007
Company: Dey, L.P.

Treatment for: Chronic Obstructive Pulmonary Disease

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The Food and Drug Administration (FDA) has approved Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

Formoterol is a rapid and long-lasting beta(2) agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has twenty years of worldwide use. Perforomist Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

About Perforomist (Formoterol Fumarate) Inhalation Solution

The clinical evaluations of Perforomist Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil(R)), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV(1) AUC(0-12). The safety and efficacy of Perforomist Inhalation Solution observed in this study were comparable to those of Foradil(R). Additionally, patients treated with Perforomist Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.

About COPD

COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes increasingly difficult. The most common forms of COPD are chronic bronchitis and emphysema, and many patients suffer from a combination of the two diseases.

COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. Twelve million Americans have been diagnosed with COPD and at least another 12 million have symptoms but are not diagnosed. COPD is not well understood or recognized -- most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases. Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization

Perforomist Inhalation Solution is a long-acting bronchodilator that is taken by nebulizer. Of the three types of devices used to deliver bronchodilators -- nebulizers, metered-dose inhalers, and dry powder inhalers -- nebulizers may offer the easiest method because they require no special technique or coordination, as the medication is converted into a fine mist that the patient inhales through a mouthpiece or face-mask while breathing naturally. Because nebulization is an easy, effective, and thorough method of delivering medicine directly into the lungs, many COPD patients prefer it, particularly as they become increasingly frail due to their disease progression.

Perforomist Inhalation Solution changes the paradigm regarding nebulization. Now, nebulization may become a more valuable and widely used treatment option for the millions of COPD patients at earlier treatment stages who would benefit from twice-daily maintenance dosing of a nebulized LABA such as Perforomist Inhalation Solution. For example, the clinical benefit of this new COPD treatment may be a valuable clinical option for patients who are not adequately controlled with short-acting bronchodilators.

Indication

Perforomist 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 Safety Information

Perforomist Inhalation Solution belongs to a class of medications known as long-acting beta(2)-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist Inhalation Solution.

Perforomist Inhalation Solution should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist Inhalation Solution should be used with caution in patients with cardiovascular disorders. Perforomist Inhalation Solution is not a substitute for inhaled or oral corticosteroids. The safety and efficacy of Perforomist Inhalation Solution in asthma has not been established.

In COPD clinical trials, the most common adverse events reported with Perforomist Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

Source: Dey, L.P.

Perforomist Medication Guide

(formoterol fumarate) Inhalation Solution

Important Use Information

1. Perforomist Inhalation Solution is for use with a standard jet nebulizer machine connected to an air compressor. Read the complete instructions for use at the end of this Medication Guide before starting Perforomist Inhalation Solution.
2. Do not swallow or inject Perforomist Inhalation Solution. Perforomist Inhalation Solution is for inhalation use only.

Read the Medication Guide that comes with Perforomist Inhalation Solution before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Perforomist Inhalation Solution?

Perforomist Inhalation Solution is a medicine called a long-acting beta2-agonist (LABA) or long-acting bronchodilator. Perforomist Inhalation Solution is used to treat chronic obstructive pulmonary disease (COPD).

• In patients with asthma, LABA medicines such as Perforomist Inhalation Solution may increase the chance of asthma-related death from asthma problems. It is not known if LABA medicines, such as Perforomist Inhalation Solution, increase the chance of death in patients with chronic obstructive pulmonary disease (COPD).
• Perforomist Inhalation Solution does not relieve sudden symptoms of COPD. Always have a short-acting beta2-agonist bronchodilator medicine with you to treat sudden symptoms. If you do not have an inhaled short-acting bronchodilator, call your healthcare provider to have one prescribed for you.
• Get emergency medical care if:
  • breathing problems worsen quickly
  • you use your short-acting beta2-agonist medicine, but it does not relieve your breathing problems
• Do not stop using Perforomist Inhalation Solution unless told to do so by your healthcare provider because your symptoms might get worse.
• Perforomist Inhalation Solution should not be used in children. Perforomist Inhalation Solution has not been studied in children.

What is Perforomist Inhalation Solution?

Perforomist Inhalation Solution is used long term, twice a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

LABA medicines such as Perforomist Inhalation Solution help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.

What should I tell my healthcare provider before using Perforomist Inhalation Solution?

Tell your healthcare provider 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.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Perforomist Inhalation Solution and certain other medicines may interact with each other. This may cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use Perforomist Inhalation Solution?

Read the step-by-step instructions for using Perforomist Inhalation Solution at the end of this Medication Guide.

• Use Perforomist Inhalation Solution exactly as prescribed. One ready-to-use vial of Perforomist Inhalation Solution is one dose. The usual dose of Perforomist Inhalation Solution is 1 ready-to-use vial, twice a day (morning and evening) breathed in through your nebulizer machine. The 2 doses should be about 12 hours apart. Do not use more than 2 vials of Perforomist Inhalation Solution a day.
• Do not mix other medicines with Perforomist Inhalation Solution in your nebulizer machine.
• If you miss a dose of Perforomist Inhalation Solution, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time.
• While you are using Perforomist Inhalation Solution twice a day:
  • do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason.
  • do not use your short-acting beta2-agonist medicine on a regular basis (four times a day).
• Make sure you always have a short-acting beta2-agonist medicine with you. Use your short-acting beta2- agonist medicine if you have breathing problems between doses of Perforomist Inhalation Solution.
• Do not change or stop any of your medicines to control or treat your COPD breathing problems. Your healthcare provider will adjust your medicines as needed.

Call your healthcare provider or get emergency medical care right away if:

• your breathing problems worsen with Perforomist Inhalation Solution
• you need to use your short-acting beta2-agonist medicine more often than usual
• your short-acting beta2-agonist medicine does not work as well for you at relieving symptoms

What are the possible side effects with Perforomist Inhalation Solution?

• In patients with asthma, LABA medicines such as Perforomist Inhalation Solution may increase the chance of asthma-related death from asthma problems.
• Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.
• chest pain
• increased or decreased blood pressure
• a fast and irregular heartbeat
• headache
• tremor
• nervousness
• dry mouth
• muscle cramps
• nausea, vomiting
• dizziness
• tiredness
• low blood potassium
• high blood sugar
• high blood acid
• trouble sleeping

Tell your healthcare provider if you get any side effect that bothers you or that does not go away. These are not all the side effects with Perforomist Inhalation Solution. Ask your healthcare provider or pharmacist for more information.

How should I store Perforomist Inhalation Solution?

• Store Perforomist Inhalation Solution in a refrigerator between 36° to 46°F (2° to 8°C) in the protective foil pouch. Protect from light and heat. Do not open a sealed pouch until you are ready to use a dose of Perforomist Inhalation Solution. Once a sealed pouch is opened, Perforomist Inhalation Solution must be used right away. Perforomist Inhalation Solution may be used directly from the refrigerator.
• Perforomist Inhalation Solution may also be stored at room temperature between 68ºF to 77ºF (20ºC to 25ºC) for up to 3 months (90 days). If stored at room temperature, discard Perforomist Inhalation Solution if it is not used after 3 months or if past the expiration date, whichever is sooner. Space is provided on the packaging to record dispense date and use by date.
• Do not use Perforomist Inhalation Solution after the expiration date provided on the foil pouch and vial.
• Perforomist Inhalation Solution should be colorless. Discard Perforomist Inhalation Solution if it is not colorless.
• Keep Perforomist Inhalation Solution and all medicines out of the reach of children.

General Information about Perforomist Inhalation Solution

Medicines are sometimes prescribed for purposes that are not mentioned in a Medication Guide. Do not use Perforomist Inhalation Solution for a condition for which it was not prescribed. Do not give Perforomist Inhalation Solution to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about Perforomist Inhalation Solution. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about Perforomist Inhalation Solution that was written for health care professionals.

Instructions for Using Perforomist (formoterol fumarate) Inhalation Solution

Perforomist Inhalation Solution is used only in a standard jet nebulizer machine connected to an air compressor. Make sure you know how to use your nebulizer machine before you use it to breathe in Perforomist Inhalation Solution or other medicines.

Do not mix Perforomist Inhalation Solution with other medicines in your nebulizer machine. Perforomist Inhalation Solution comes sealed in a foil pouch. Do not open a sealed pouch until you are ready to use a dose of Perforomist Inhalation Solution.

1. Remove vial from the foil pouch.
2. Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir).
3. Connect the nebulizer reservoir to the mouthpiece or facemask.
4. Connect the nebulizer to the compressor.
5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth or put on the facemask and turn on the compressor.
6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer reservoir. The average nebulization time is 9 minutes. At this point, the treatment is finished.
7. Discard the Perforomist Inhalation Solution container and top after use.
8. Clean the nebulizer (see manufacturer’s instructions).

Rx Only

This Medication Guide has been approved by the Food and Drug Administration

For full prescribing information, please visit www.perforomist.com

Source: Dey, L.P.

April 2007

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