"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).
There have been no reports of overdose with KALYDECO.
The highest single dose used in a clinical study was 800 mg in a solution formulation without any treatment-related adverse events.
The highest repeated dose was 450 mg (in a tablet formulation) every 12 hours for 4.5 days (9 doses) in a trial evaluating the effect of KALYDECO on ECGs in healthy subjects. Adverse events reported at a higher incidence compared to placebo included dizziness and diarrhea.
No specific antidote is available for overdose with KALYDECO. Treatment of overdose with KALYDECO consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Last reviewed on RxList: 7/15/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Kalydeco Information
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