Generic Name
Formoterol
Brand Names
Perforomist, Duaklir Pressair
FDA approval date: October 01, 2007
Classification: beta2-Adrenergic Agonist
Form: Powder, Solution
What is Perforomist (Formoterol)?
Formoterol fumarate inhalation solution is a long-acting beta 2 -adrenergic agonist indicated for: Long-term, twice daily administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease , including chronic bronchitis and emphysema.
Approved To Treat
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Brand Information
Perforomist (formoterol fumarate dihydrate)
1DOSAGE AND ADMINISTRATION
The recommended dose of PERFOROMIST (formoterol fumarate) Inhalation Solution is one 20 mcg unit-dose vial administered twice daily (morning and evening) by nebulization. A total daily dose greater than 40 mcg is not recommended.
PERFOROMIST Inhalation Solution should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor. The safety and efficacy of PERFOROMIST Inhalation Solution have been established in clinical trials when administered using the PARI-LC Plus
PERFOROMIST Inhalation Solution should always be stored in the foil pouch, and only removed IMMEDIATELY BEFORE USE. Contents of any partially used container should be discarded.
If the recommended maintenance treatment regimen fails to provide the usual response, medical advice should be sought immediately, as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be re-evaluated and additional therapeutic options should be considered.
The drug compatibility (physical and chemical), efficacy, and safety of PERFOROMIST Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
2DOSAGE FORMS AND STRENGTHS
PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a sterile solution for nebulization in low-density polyethylene unit-dose vials. Each vial contains formoterol fumarate dihydrate, USP equivalent to 20 mcg/2 mL of formoterol fumarate.
3CONTRAINDICATIONS
Use of a LABA, including PERFOROMIST, without an inhaled corticosteroid is contraindicated in patients with asthma WARNINGS and PRECAUTIONS (5.1)]. PERFOROMIST is not indicated for the treatment of asthma.
4ADVERSE REACTIONS
Long-acting beta
4.1Beta-Agonist Adverse Reaction Profile
Adverse reactions to PERFOROMIST Inhalation Solution are expected to be similar in nature to other beta
4.2Clinical 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.
4.2.1Adults 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 FEV
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.
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.
4.3Postmarketing 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
5OVERDOSAGE
The expected signs and symptoms with overdosage of PERFOROMIST Inhalation Solution are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the signs and symptoms listed under
Treatment of overdosage consists of discontinuation of PERFOROMIST Inhalation Solution together with institution of appropriate symptomatic and/or supportive therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of PERFOROMIST Inhalation Solution. Cardiac monitoring is recommended in cases of overdosage.
For additional information about overdose treatment, call a poison control center (1-800-222-1222).
6DESCRIPTION
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 beta
Formoterol fumarate dihydrate, USP has a molecular weight of 840.92 and its empirical formula is (C
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
7HOW SUPPLIED/STORAGE AND HANDLING
PERFOROMIST (formoterol fumarate) Inhalation Solution is supplied as a 2 mL sterile solution for nebulization in 2.5 mL low-density polyethylene unit dose vials. Each vial is overwrapped in a foil pouch and supplied in cartons as listed below.
Carton of 30 individually wrapped unit dose vials,
Carton of 60 individually wrapped unit dose vials,
Storage and Handling:
Prior to dispensing to the patient: Store in a refrigerator, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat.
After dispensing to the patient: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
- PERFOROMIST Inhalation Solution should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow and equipped with a facemask or mouthpiece.
- Vial should always be stored in the foil pouch, and only removed IMMEDIATELY before use.
- Do not take by mouth.
- Contents of any partially used container should be discarded.
- Discard the container and top after use.
- Keep out of the reach of children
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Serious Asthma-Related Events
Inform patients that long-acting beta agonist, such as PERFOROMIST, when used as monotherapy [without an inhaled corticosteroid], increase the risk of serious asthma-related events, including asthma-related death. PERFOROMIST is not indicated for the treatment of asthma.
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 beta
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.
Concomitant Therapy
Patients who have been taking inhaled, short-acting beta
Common Adverse Reactions with Beta
Patients should be informed that treatment with beta
Instructions for Administration
It is important that patients understand how to use PERFOROMIST Inhalation Solution with a nebulizer appropriately
Manufactured for:
Manufactured by:
U.S. Pat. No. 6,667,344
FORMIS:R3
The brands listed are trademarks of their respective owners.
9PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 5/2019 PIL:FORMIS:R1
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.
- Remove vial from the foil pouch.
- Twist the cap completely off the vial and squeeze all the medicine into the nebulizer medicine cup (reservoir) (Figure 1).
- Connect the nebulizer reservoir to the mouthpiece or facemask (Figure 2).
- Connect the nebulizer to the compressor.
- 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.
- 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.
- Discard the PERFOROMIST Inhalation Solution container and top after use.
- Clean the nebulizer (see manufacturer’s instructions).
Manufactured for:
Manufactured by:
This Instructions for Use has been approved by the U.S. Food and Drug Administration
Revised: 5/2019
10PRINCIPAL DISPLAY PANEL – 20 mcg/2 mL
NDC 49502-605-30
Perforomist
(formoterol fumarate) INHALATION SOLUTION
20 mcg/2 mL vial
(formoterol fumarate) INHALATION SOLUTION
20 mcg/2 mL vial
Patient Information for Patients Enclosed
Sterile Unit Dose Vials -
EACH 2 mL VIAL CONTAINS: ACTIVE: Formoterol fumarate, USP.
INACTIVES: Citric acid, sodium citrate, sodium chloride, and water.
CARTON CONTAINS: 30 individually wrapped 2 mL vials
Discard three months
STORAGE CONDITIONS:
PRIOR TO DISPENSING TO THE PATIENT: Store refrigerated, 2°C to 8°C (36°F to 46°F). Protect pouch from light and heat.
AFTER DISPENSING TO THE PATIENT: Store in a refrigerator at 2°C to 8°C (36°F to 46°F) and discard when drug expires or store at room temperature, 20°C to 25°C (68°F to 77°F) and discard if not used after 3 months. Protect pouch from light and heat.
VIAL SHOULD ALWAYS BE STORED IN THE FOIL POUCH, AND ONLY REMOVED IMMEDIATELY BEFORE USE.
Keep out of reach of children.
FOR THE HEALTHCARE PROVIDER: When Perforomist
FOR THE PATIENT: Use Perforomist
Rx only
Manufactured for:
Manufactured by:
U.S. Pat. Nos. 6,667,344, 6,814,953, 7,348,362, 7,462,645, 8,623,922, and 9,730,890
Mylan Specialty L.P., Morgantown, WV 26505
MS:605:30C:R3 RPSC0340
