Formoterol Fumarate Inhalation Solution

Name: Formoterol Fumarate Inhalation Solution

Description

PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as 2 mL of formoterol fumarate inhalation solution packaged in a 2.5 mL single-use low-density polyethylene vial and overwrapped in a foil pouch. Each vial contains 2 mL of a clear, colorless solution composed of formoterol fumarate dihydrate, USP equivalent to 20 mcg of formoterol fumarate in an isotonic, sterile aqueous solution containing sodium chloride, pH adjusted to 5.0 with citric acid and sodium citrate.

The active component of PERFOROMIST Inhalation Solution is formoterol fumarate dihydrate, USP, a racemate. Formoterol fumarate dihydrate is a beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1-methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is:

Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C19H24N2O4)2•C4H4O4•2H2O. Formoterol fumarate dihydrate, USP is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.

PERFOROMIST Inhalation Solution does not require dilution prior to administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors and the nebulization system used and its performance.

Using the PARI-LC Plus® nebulizer (with a facemask or mouthpiece) connected to a PRONEB® Ultra compressor under in vitro conditions, the mean delivered dose from the mouthpiece was approximately 7.3 mcg (37% of label claim). The mean nebulizer flow rate was 4 LPM and the nebulization time was 9 minutes. PERFOROMIST Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via a facemask or mouthpiece.

Side effects

Long acting beta2-adrenergic agonists such as formoterol increase the risk of asthma-related death [See BOXED WARNING and WARNINGS AND PRECAUTIONS].

Beta2-Agonist Adverse Reaction Profile

Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta2-adrenergic receptor agonists including: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, dry mouth, muscle cramps, palpitations, nausea, dizziness, fatigue, malaise, insomnia, hypokalemia, hyperglycemia, and metabolic acidosis.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults with COPD

The data described below reflect exposure to PERFOROMIST Inhalation Solution 20 mcg twice daily by oral inhalation in 586 patients, including 232 exposed for 6 months and 155 exposed for at least 1 year. PERFOROMIST Inhalation Solution was studied in a 12-week, placebo- and active-controlled trial (123 subjects treated with PERFOROMIST Inhalation Solution) and a 52-week, active-controlled trial (463 subjects treated with PERFOROMIST Inhalation Solution). Patients were mostly Caucasians (88%) between 40-90 years old (mean, 64 years old) and had COPD, with a mean FEV1 of 1.33 L. Patients with significant concurrent cardiac and other medical diseases were excluded from the trials.

Table 1 shows adverse reactions from the 12-week, double-blind, placebo-controlled trial where the frequency was greater than or equal to 2% in the PERFOROMIST Inhalation Solution group and where the rate in the PERFOROMIST Inhalation Solution group exceeded the rate in the placebo group. In this trial, the frequency of patients experiencing cardiovascular adverse events was 4.1% for PERFOROMIST Inhalation Solution and 4.4% for placebo. There were no frequently occurring specific cardiovascular adverse events for PERFOROMIST Inhalation Solution (frequency greater than or equal to 1% and greater than placebo). The rate of COPD exacerbations was 4.1% for PERFOROMIST Inhalation Solution and 7.9% for placebo.

TABLE 1: Number of patients with adverse reactions in the 12-weekmultiple-dose controlled clinical trial

Adverse Reaction PERFOROMIST
Inhalation Solution
20 mcg
Placebo
n (%) n (%)
Total Patients 123 (100) 114 (100)
Diarrhea 6 (4.9) 4 (3.5)
Nausea 6 (4.9) 3 (2.6)
Nasopharyngitis 4 (3.3) 2 (18)
Dry Mouth 4 (3.3) 2 (18)
Vomiting 3 (2.4) 2 (18)
Dizzines 3 (2.4) 1 (0.9)
Insomnia 3 (2.4) 0 0

Patients treated with PERFOROMIST Inhalation Solution 20 mcg twice daily in the 52-week open-label trial did not experience an increase in specific clinically significant adverse events above the number expected based on the medical condition and age of the patients.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of PERFOROMIST Inhalation Solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylactic reactions, urticaria, angioedema (presenting as face, lip, tongue, eye, pharyngeal, or mouth edema), rash, and bronchospasm

Warnings

Included as part of the PRECAUTIONS section.

Patient information

PERFOROMIST®
(Per-FOR-o-mist)
(formoterol fumarate) Inhalation Solution

PERFOROMIST Inhalation Solution is only for use with a nebulizer.

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 can cause serious side effects including:

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems.
  • It is not known if LABA medicines, such as PERFOROMIST Inhalation Solution, increase the risk of death in people with chronic obstructive pulmonary disease (COPD).
  • Get emergency medical care if:
    • breathing problems worsen quickly
    • you use your rescue inhaler medicine, but it does not relieve your breathing problems

What is PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution is used long term, 2 times a day (morning and evening), in controlling symptoms of chronic obstructive pulmonary disease (COPD) in adults with COPD.

PERFOROMIST Inhalation Solution is only for use with a nebulizer. 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.

PERFOROMIST Inhalation Solution is not for use to treat sudden symptoms of COPD.

PERFOROMIST Inhalation Solution should not be used in children. It is not known if PERFOROMIST Inhalation Solution is safe and effective in children.

It is not known if PERFOROMIST Inhalation Solution is safe and effective in people with asthma.

Who should not use PERFOROMIST Inhalation Solution?

Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine.

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 non-prescription 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 one 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 2 times each 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).
  • PERFOROMIST Inhalation Solution does not relieve sudden symptoms of COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler medicine, call your healthcare provider to have one prescribed for you.
  • Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
  • Do not use PERFOROMIST Inhalation Solution:
    • more often than prescribed,
    • more medicine than prescribed for you, or
    • with other LABA medicines

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 rescue inhaler medicine more often than usual
  • your rescue inhaler medicine does not work as well for you at relieving symptoms

What are the possible side effects of PERFOROMIST Inhalation Solution?

PERFOROMIST Inhalation Solution can cause serious side effects, including:

  • See “What is the most important information I should know about PERFOROMIST Inhalation Solution?”
  • Sudden shortness of breath immediately after use of PERFOROMIST Inhalation Solution.
  • 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
  • low blood potassium
  • high blood sugar
  • high blood acid

Common side effects of PERFOROMIST Inhalation Solution include:

  • headache
  • tremor
  • nervousness
  • dry mouth
  • muscle cramps
  • nausea, vomiting
  • diarrhea
  • dizziness
  • tiredness
  • trouble sleeping

If your COPD symptoms worsen over time do not increase your dose of PERFOROMIST Inhalation Solution, instead call your healthcare provider.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 68°F to 77°F (20°C to 25°C) 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 healthcare professionals.

  • For customer service, call 1-800-395-3376
  • To report side effects, call 1-877-446-3679
  • For medical information, call 1-800-429-7751

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) (Figure 1).

3. Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).

4. Connect the nebulizer to the compressor.

5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (Figure 3) or put on the facemask (Figure 4); 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).

What is formoterol inhalation (foradil aerolizer, perforomist)?

Formoterol is a long-acting bronchodilator that relaxes muscles in the airways to improve breathing.

Formoterol inhalation is used to prevent bronchospasm in people with reversible obstructive airways disease, including symptoms of night-time asthma. It is also used in people with chronic obstructive pulmonary disease (COPD) such as emphysema and chronic bronchitis.

Formoterol inhalation may also be used for purposes not listed in this medication guide.

What should i avoid while using formoterol inhalation (foradil aerolizer, perforomist)?

Do not use a second form of formoterol (such as Symbicort) or use a similar other long-acting inhaled bronchodilator such as salmeterol (Advair, Serevent) or arformoterol (Brovana) unless your doctor has told you to.

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