Tudorza Pressair

Tudorza Pressair is a prescription medication used to treat symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Tudorza Pressair belongs to a group of drugs called antimuscarinic bronchodilators. These work to treat COPD by relaxing the muscles of the airways and opening the air passages to the lungs, which makes it easier to breathe.

This medication comes in a dry powder inhaler form and is typically inhaled into the lungs twice daily.

Common side effects of Tudorza Pressair include headache, irritation and/or inflammation of the nose and throat, and cough.

Serious side effects have been reported with Tudorza Pressair including the following:

Sudden shortness of breath. Although rare, a sudden shortness of breath due to closing of the airways has been reported with medications similar to Tudorza Pressair. If this occurs, discontinue use immediately and get medical attention. Other treatments may need to be considered 

Worsening of glaucoma. If you have narrow-angle glaucoma, Tudorza Pressair may cause a worsening of symptoms.  This is a serious side effect that can lead to permanent loss of vision if not treated. Consult with your physician immediately if you experience any symptoms of worsening glaucoma. Symptoms of worsening acute narrow-angle glaucoma may include:

• eye pain 
• eye discomfort
• upset stomach or vomiting
• blurred vision
• seeing halos or bright colors around lights
• red eyes

Urinary retention (inability to urinate). This medication should be used with caution if you have existing urinary problems. Urinary retention can be caused by blockage in your bladder or, if you are a male, a larger than normal prostate. Symptoms of urinary retention may include:

• difficulty urinating
• painful urination
• urinating frequently
• urination in a weak stream or drips

If you experience any of these symptoms of urinary retention, stop taking Tudorza Pressair and tell your doctor right away.

• sudden difficulty breathing
• sudden and abnormal swelling of the lips, mouth, and/or tongue
• sudden onset of a red blister-like skin rash (hives)
• sudden drop in blood pressure

• your breathing problems worsen with Tudorza Pressair
• you need to use your rescue inhaler medicine more often that usual
• your rescue inhaler medicine does not work as well for you at relieving your symptoms 

• are allergic to Tudorza Pressair or to any of its ingredients

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Tudorza Pressair for the long-term maintenance treatment of symptoms of chronic obstructive pulmonary disease (COPD) is 400 mcg (one inhalation) inhaled by mouth, typically twice per day.

If you take too much Tudorza Pressair, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication gets in your eyes, rinse with water.

COPD

Long-term maintenance treatment of reversible bronchospasm associated with COPD, including chronic bronchitis and emphysema.1 4 11 12 13 14

Not indicated for treatment of acute episodes of bronchospasm (i.e., as rescue therapy) or acute exacerbations of COPD.9

Metabolized primarily by hydrolysis; occurs chemically and enzymatically via esterases.1

Does not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, or 4A9/11.1

Specific Drugs

Chronic Obstructive Pulmonary Disease (COPD)

The Tudorza Pressair clinical development program included a dose-ranging trial (Trial A) for nominal dose selection and three confirmatory trials (Trials B, C, and D).

Dose-ranging trial

Trial A was a randomized, double-blind, placebo-controlled, active-controlled, crossover trial with 7-day treatment periods separated by 5-day washout periods. Trial A enrolled 79 patients who had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking at least 10 pack-years, had a forced expiratory volume in one second (FEV1) of at least 30% and less than 80% of predicted normal value, and a ratio of FEV1 over forced vital capacity (FEV1/FVC) of less than 0.7. Trial A included Tudorza Pressair doses of 400 mcg, 200 mcg and 100 mcg twice daily, formoterol active control, and placebo. Trial A demonstrated that the effect on trough FEV1 and serial FEV1 in patients treated with the Tudorza Pressair 100 mcg twice daily and 200 mcg twice daily doses was lower compared to patients treated with the Tudorza Pressair 400 mcg twice daily dose (Figure 1).

Figure 1: Change from baseline in FEV1Over Time (prior to and after administration of study drug) at Week 1 in Trial A

Confirmatory trials

Trials B, C, and D were three randomized, double-blind, placebo-controlled trials in patients with COPD. Trials B and C were 3 months in duration, and Trial D was 6 months in duration. These trials enrolled 1,276 patients who had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking at least 10 pack-years, had an FEV1 of at least 30% and less than 80% of predicted normal value, and a ratio of FEV1/FVC of less than 0.7; 59% were male, and 93% were Caucasian.

These clinical trials evaluated Tudorza Pressair 400 mcg twice daily (636 patients) and placebo (640 patients). Tudorza Pressair 400 mcg resulted in statistically significantly greater bronchodilation as measured by change from baseline in morning pre-dose FEV1 at 12 weeks (the primary efficacy endpoint) compared to placebo in all three trials (Table 2).

Serial spirometric evaluations were performed throughout daytime hours in a subset of patients in the three trials. The serial FEV1 values over 12 hours for one of the 3-month trials (Trial B) are displayed in Figure 2. Results for the other two placebo-controlled trials were similar to the results for Trial B. Improvement of lung function was maintained for 12 hours after a single dose and was consistent over the 3- or 6-month treatment period.

Figure 2: Mean FEV1 Over Time (prior to and after administration of study drug) on Day 1 and Week 12 in Subset of Patients Participating in the 12 hours Serial Spirometry Substudy for Trial B (a 3-month Placebo-Controlled Study)

Mean peak improvements in FEV1, for Tudorza Pressair relative to baseline were assessed in all patients in trials B, C and D after the first dose on day 1 and were similar at week 12. In Trials B and D, but not in Trial C, patients treated with Tudorza Pressair used less daily rescue albuterol during the trial compared to patients treated with placebo.

You should not use Tudorza Pressair if you are allergic to aclidinium or to milk proteins.

To make sure Tudorza Pressair is safe for you, tell your doctor if you have:

• narrow-angle glaucoma;

• enlarged prostate; or

• bladder obstruction or other urination problems.

It is not known whether Tudorza Pressair will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether aclidinium passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Tudorza Pressair is not approved for use by anyone younger than 18 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.