"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
The following adverse reactions are described in greater detail in other sections:
- Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
- Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
- Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
- Immediate Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
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.
3-Month and 6-Month Trials
TUDORZA PRESSAIR was studied in two 3-month (Trials B and C) and one 6-month (Trial D) placebo-controlled trials in patients with COPD. In these trials, 636 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily.
The population had a mean age of 64 years (ranging from 40 to 89 years), with 58% males, 94% Caucasian, and had COPD with a mean pre-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 48%. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.
Table 1 shows all adverse reactions that occurred with a frequency of greater than or equal to 1% in the TUDORZA PRESSAIR group in the two 3-month and one 6-month placebo-controlled trials where the rates in the TUDORZA PRESSAIR group exceeded placebo.
Table 1: Adverse Reactions (% Patients) in
Placebo-Controlled Clinical Trials
(N = 636)
(N = 640)
|Headache||42 (6.6)||32 (5.0)|
|Nasopharyngitis||35 (5.5)||25 (3.9)|
|Cough||19 (3.0)||14 (2.2)|
|Diarrhea||17 (2.7)||9 (1.4)|
|Sinusitis||11 (1.7)||5 (0.8)|
|Rhinitis||10 (1.6)||8 (1.2)|
|Toothache||7 (1.1)||5 (0.8)|
|Fall||7 (1.1)||3 (0.5)|
|Vomiting||7 (1.1)||3 (0.5)|
In addition, among the adverse reactions observed in the clinical trials with an incidence of less than 1% were diabetes mellitus, dry mouth, 1st degree AV block, osteoarthritis, cardiac failure, and cardio-respiratory arrest.
Long-term Safety Trials
TUDORZA PRESSAIR was studied in three long term safety trials, two double blind and one open label, ranging from 40 to 52 weeks in patients with moderate to severe COPD. Two of these trials were extensions of the 3-month trials, and one was a dedicated long term safety trial. In these trials, 891 patients were treated with TUDORZA PRESSAIR at the recommended dose of 400 mcg twice daily. The demographic and baseline characteristics of the long term safety trials were similar to those of the placebo-controlled trials. The adverse events reported in the long term safety trials were similar to those occurring in the placebo-controlled trials of 3 to 6 months. No new safety findings were reported compared to the placebo controlled trials.
The following adverse reactions have been identified during postapproval use of drug TUDORZA PRESSAIR. 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.
In postmarketing experience with TUDORZA PRESSAIR, immediate hypersensitivity reactions, including anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have been reported.
Read the Tudorza Pressair (aclidinium bromide) Side Effects Center for a complete guide to possible side effects
In vitro studies suggest limited potential for CYP450-related metabolic drug interactions, thus no formal drug interaction studies have been performed with TUDORZA PRESSAIR [see CLINICAL PHARMACOLOGY].
Sympathomimetics, Methylxanthines, Steroids
In clinical studies, concurrent administration of aclidinium bromide and other drugs commonly used in the treatment of COPD including sympathomimetics (short-acting beta2 agonists), methylxanthines, and oral and inhaled steroids showed no increases in adverse drug reactions.
There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid coadministration of TUDORZA PRESSAIR with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic effects.
Read the Tudorza Pressair Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/20/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Tudorza Pressair Information
- Tudorza Pressair Drug Interactions Center: aclidinium bromide inhl
- Tudorza Pressair Side Effects Center
- Tudorza Pressair FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.