Aclidinium Bromide (Tudorza Pressair)

Trade Name : Tudorza Pressair

AstraZeneca Pharmaceuticals LP

POWDER, METERED

Strength 400 ug/1

ACLIDINIUM BROMIDE Anticholinergic [EPC],Cholinergic Antagonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Aclidinium Bromide (Tudorza Pressair) which is also known as Tudorza Pressair and Manufactured by AstraZeneca Pharmaceuticals LP. It is available in strength of 400 ug/1 per ml. Read more

Aclidinium Bromide (Tudorza Pressair) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usage u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a003/2019
  • TUDORZAu00ae PRESSAIRu00ae (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD
  • TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). n
  • The recommended dose of TUDORZA PRESSAIR is one oral inhalation of 400 mcg, twice daily (morning and evening approximately 12 hours apart).
  • For oral inhalation only
  • u2022
  • (2)
  • Inhalation Powder. TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler metering 400 mcg of aclidinium bromide per actuation.
  • u2022
  • (3)
  • The use of TUDORZA PRESSAIR is contraindicated in the following conditions:
  • No data
  • The following adverse reactions are described in greater detail in other sections:
  • Most common adverse reactions (u22653% incidence and greater than placebo) are headache, nasopharyngitis and cough. n
  • To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or .
  • Anticholinergics: May interact additively with concomitantly used anticholinergic medications. Avoid administrations of TUDORZA PRESSAIR with other anticholinergic-containing drugs. ()
  • No data
  • No case of overdose has been reported in clinical studies with TUDORZA PRESSAIR. There were no systemic anticholinergic or other adverse effects following a single inhaled dose of up to 6,000 mcg aclidinium bromide (7.5 times the RHDD) in 16 healthy volunteers.
  • TUDORZA PRESSAIR consists of a dry powder formulation of aclidinium bromide for oral inhalation only.
  • Aclidinium bromide, the active component of TUDORZA PRESSAIR is an anticholinergic with specificity for muscarinic receptors. Aclidinium bromide is a synthetic, quaternary ammonium compound, chemically described as 1-azoniabicyclo[2.2.2]octane, 3-[(hydroxydi-2-thienylacetyl)oxy]-1-(3-phenoxypropyl)-, bromide, (3)-. The structural formula is:
  • Aclidinium bromide is a white powder with a molecular formula of CHNOSBr and a molecular mass of 564.56. It is very slightly soluble in water and ethanol and sparingly soluble in methanol.
  • TUDORZA PRESSAIR is a breath-actuated multi-dose dry powder inhaler. Each actuation of TUDORZA PRESSAIR provides a metered dose of 13 mg of the formulation which contains lactose monohydrate (which may contain milk proteins) as the carrier and 400 mcg of aclidinium bromide (equivalent to 343 mcg of aclidinium). This results in delivery of 375 mcg aclidinium bromide (equivalent to 322 mcg of aclidinium) from the mouthpiece, based on testing at an average flow rate of 63 L/min with constant volume of 2 L. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow rate and inspiratory time.
  • No data
  • Two-year inhalation studies were conducted in mice and rats to assess the carcinogenic potential of aclidinium bromide. No evidence of tumorigenicity was observed in rats and mice at aclidinium doses up to 0.20 and 2.4 mg/kg/day, respectively [approximately 10 and 80 times the Maximum Recommended Human Daily Inhalation Dose (MRHDID), respectively, based on summed AUCs of aclidinium bromide and its metabolites].
  • Aclidinium bromide was positive in the bacterial gene mutation assay and the thymidine locus mouse lymphoma assay. However, aclidinium bromide was negative in the mouse micronucleus assay and the unscheduled DNA synthesis assay with rat liver.
  • Aclidinium bromide impaired several fertility and reproductive performance indices (increased number of days to mate, decreased conception rate, decreased number of corpora lutea, increased pre-implantation loss with consequent decreased number of implantations, and live embryos) in both male and female rats administered inhaled doses greater than or equal to 0.8 mg/kg/day [approximately 15 times the MRHDID based on summed AUCs of aclidinium bromide and its metabolites]. These adverse fertility effects were observed in the presence of paternal toxicity as evidenced by mortality and decreased body weight gain. However, there were no effects on mating index and sperm number and morphology. In the separate fertility assessments (treated males mated with untreated females; treated females mated with untreated males), no effect was observed in male and female rats at inhaled doses of 1.9 and 0.8 mg/kg/day, respectively [approximately 30 and 15 times the MRHDID, respectively, based on summed AUCs of aclidinium bromide and its metabolites].
  • The TUDORZA PRESSAIR clinical development program included a dose-ranging trial (Trial A) for nominal dose selection and three confirmatory lung function trials (Trials B, C, and D). Two additional lung function trials (Trials E and F) of aclidinium bromide alone and as part of a fixed-dose combination product also provided information on the effect of TUDORZA PRESSAIR on the St. Georgeu2019s Respiratory Questionnaire (SGRQ) total score compared to placebo. A long-term study of up to 3 years (Trial G) evaluated the effect of TUDORZA PRESSAIR on major adverse cardiovascular events and on COPD exacerbations.
  • Dose-ranging trial
  • Trial A (NCT01120093) 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 (FEV) of at least 30% and less than 80% of predicted normal value, and a ratio of FEV over forced vital capacity (FEV/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 FEV and serial FEV 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: Change from baseline in FEV Over Time (prior to and after administration of study drug) at Week 1 in Trial A
  • Confirmatory trials
  • Trials B (NCT00891462), C (NCT01045161), and D (NCT01001494) 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, including chronic bronchitis and emphysema, were 40 years of age or older, had a history of smoking at least 10 pack-years, had an FEV of at least 30% and less than 80% of predicted normal value, and a ratio of FEV/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 FEV at 12 weeks (the primary efficacy endpoint) compared to placebo in all three trials ().
  • Serial spirometric evaluations were performed throughout daytime hours in a subset of patients in the three trials. The serial FEV values over 12 hours for one of the 3-month trials (Trial B) are displayed in . 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 FEV 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 FEV, 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.
  • Trials E (NCT01437397) and F (NCT01462942) were two randomized, double-blind, placebo-controlled trials of an aclidinium bromide-containing fixed- dose combination product and its components compared to placebo in patients with COPD, including chronic bronchitis and emphysema. Trials E and F were 6 months in duration. These trials enrolled 3421 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 FEV of at least 30% and less than 80%, and a ratio of FEV/FVC less than 0.7; 60.5% were male, 94.1% were Caucasian.
  • The St. Georgeu2019s Respiratory Questionnaire (SGRQ) was assessed in Trials D, E, and F at 6 months. In Trial D, the SGRQ responder rate (defined as an improvement in score of 4 or more as threshold) was 54.3% in TUDORZA PRESSAIR compared to 39.5% in placebo, with odds ratio of 1.77 (95% CI 1.25, 2.52). In Trial E, the SGRQ responder rate in the TUDORZA PRESSAIR group was 54.5% compared to 38.7% in the placebo group, with odds ratio of 2.18 (95% CI 1.37, 3.48). In Trial F, the SGRQ responder rate in the TUDORZA PRESSAIR group was 53.5% compared to 53.2% in the placebo group, with odds ratio of 0.99 (95% CI 0.6, 1.64).
  • Long Term Safety and Efficacy Trial of up to 3-years
  • Trial G (NCT01966107) was a randomized, double-blind, placebo-controlled study of up to 36 months that evaluated the effect of TUDORZA PRESSAIR on major adverse cardiovascular events and COPD exacerbations in patients with moderate to very severe COPD with and without a history of COPD exacerbations.
  • The trial enrolled 3630 patients with COPD, including chronic bronchitis and emphysema, between 40 and 91 years of age, 58.7% were male and 90.7% were Caucasian, with a mean post-bronchodilator FEV1 of 47.9% of predicted value. All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors. All patients had moderate to very severe COPD. 60.1% of patients had at least one prior moderate or severe COPD exacerbation within the past 12 months from the screening visit, and 39.9% had no history of a moderate or severe COPD exacerbation within the past 12 months.
  • Approximately 48% of enrolled patients had a prior history of at least 1 documented previous CV event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral vascular disease or history of claudication (13.6%); 63.6% of them were on long-acting u03b22-adrenergic agonist (LABA or LABA/inhaled corticosteroid (ICS) maintenance therapy at study entry (LABA only 6.3%, LABA/ICS 57.3%)). The majority of patients had moderate (45.1%) or severe (40.2%) airflow obstruction.
  • The primary safety endpoint was the time to first occurrence of a major adverse cardiovascular event (MACE), defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke. The study was designed to exclude a pre-specified risk margin of 1.8 for the hazard ratio of MACE.
  • The results of Trial G, including each component event of the primary composite endpoint, are shown in Table 3. The proportion of patients with at least one MACE was 3.9% in the TUDORZA PRESSAIR group compared to 4.2% in the placebo group. The incidence rate of MACE was 2.4 per 100 patient-years on TUDORZA PRESSAIR vs. 2.8 per 100 patient-years on placebo. The estimated hazard ratio of MACE associated with TUDORZA PRESSAIR relative to placebo was 0.89 with a 95% confidence interval of (0.64, 1.23). The upper bound of this confidence interval, 1.23, excluded a risk margin larger than 1.8. TUDORZA PRESSAIR was non-inferior to placebo for risk of major adverse cardiovascular events.
  • The Kaplan-Meier-based cumulative event probability is presented in Figure 3 for time to first occurrence of the primary MACE composite endpoint by treatment arm.
  • Figure 3: Estimated Cumulative Incidence of First MACE
  • Exacerbations
  • Trial G also evaluated the effect of TUDORZA PRESSAIR 400 mcg BID on COPD exacerbations. The primary efficacy endpoint was the rate of moderate to severe exacerbations during the first year of treatment, defined as worsening of COPD symptoms (dyspnea, cough, sputum) for at least 2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or led to death. In total, 54.3% of patients in Trial G completed the first year of treatment, with 9.8% patients treated less than 12 months due to study closure. TUDORZA PRESSAIR demonstrated a statistically significant reduction in the rate of on-study moderate to severe COPD exacerbations during the first year by 17% compared to placebo (rate ratio [RR] 0.83; 95% CI 0.73 to 0.94; p=0.003). TUDORZA PRESSAIR also demonstrated a statistically significant reduction in the rate of on-study hospitalizations due to COPD exacerbation during the first year by 28% compared with placebo (RR 0.72; 95% CI 0.55 to 0.95; p=0.02).
  • Figure 4: Time to first moderate or severe COPD exacerbation (days), on-study analysis, Kaplan-Meier plot (Full Analysis Set)
  • p-value for comparing Aclidinium 400 mcg versus Placebo is based on the Log-rank test stratified by baseline COPD severity and smoking status is p = 0.004.
  • The Kaplan-Meier curves indicate that the time to first on-study moderate or severe COPD exacerbation was delayed in the aclidinium 400 mcg group compared to the placebo group (see ). Patients in the aclidinium bromide 400 mcg group had a 15% relative reduction of the risk of an exacerbation (HR 0.85; 95% CI [0.77, 0.95], p=0.004).
  • TUDORZA PRESSAIR(aclidinium bromide inhalation powder) 400 mcg is supplied in a sealed bag and is available in 60 metered doses (NDC 0310-0800-60) and 30 metered doses (NDC 0310-0800-39).
  • The active ingredient is administered using a multi-dose dry powder inhaler, PRESSAIR, which delivers 60 doses or 30 doses of aclidinium bromide powder for oral inhalation. The PRESSAIR inhaler is a white and green colored device and is comprised of an assembled plastic dosing mechanism with a dose indicator, a drug-product storage unit containing the drug-product formulation, and a mouthpiece covered by a green protective cap.
  • Store TUDORZA PRESSAIR in a dry place at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) . Do not store the inhaler on a vibrating surface.
  • The PRESSAIR inhaler should be stored inside the sealed bag and only be opened immediately before use. Throw away the bag.
  • Throw away (dispose of) the PRESSAIR inhaler after the marking u201c0u201d with a red background shows in the middle of the dose indicator, when the device is empty and locks out, or 45 days after the date you opened the sealed bag that the inhaler comes in, whichever comes first.
  • Keep out of reach of children.
  • See FDA-approved Patient Labeling (Patient Information and Instructions for Use)
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0Inform patients that care must be taken not to allow the powder to enter into the eyes as this may cause blurring of u00a0u00a0u00a0u00a0u00a0u00a0u00a0vision and pupil dilation.
  • Inform patients that if they miss a dose, they should take their next dose at the usual time; they should not take 2 doses at one time.
  • Distributed by:AstraZeneca Pharmaceuticals LP,
  • Wilmington, DE 19850
  • Under license of ALMIRALL, S.A.
  • TUDORZAn n- PRESSAIRn
  • u00a9 AstraZeneca 2019
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: April 2019
  • NDC 0310-0800-60u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0R only
  • Tudorza Pressairn
  • (aclidinium bromide inhalation powder)
  • 400 mcg per actuation
  • For Oral Inhalation
  • 60 Metered Doses
  • AstraZeneca

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