"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days.
Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients.
Table 1: Adverse Reactions Reported in more than 5% of
Patients Treated with CAYSTON in the Placebo-Controlled Trials
|Event (Preferred Term)||Placebo
(N = 160)
|CAYSTON 75 mg 3 times a day (N
|Cough||82 (51%)||79 (54%)|
|Nasal congestion||19 (12%)||23 (16%)|
|Wheezing||16 (10%)||23 (16%)|
|Pharyngolaryngeal pain||17 (11%)||18 (12%)|
|Pyrexia||9 (6%)||19 (13%)|
|Chest discomfort||10 (6%)||11 (8%)|
|Abdominal Pain||8 (5%)||10 (7%)|
|Vomiting||7 (4%)||9 (6%)|
Adverse reactions that occurred in less than 5% of patients treated with CAYSTON were bronchospasm (3%) [see WARNINGS AND PRECAUTIONS] and rash (2%).
In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of CAYSTON. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
Musculoskeletal And Connective Tissue Disorders
Arthralgia, joint swelling
Read the Cayston (aztreonam for inhalation solution) Side Effects Center for a complete guide to possible side effects
No formal clinical studies of drug interactions with CAYSTON have been conducted.
Read the Cayston Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 10/10/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Cayston Information
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.