KEVEYIS

After single-dose administration in healthy subjects in fasted state, dichlorphenamide C max and AUC increased in a dose-proportional manner within the range of 25 mg to 400 mg (2 times the maximum recommended dose). The steady-state is expected to be achieved within 10 days of twice-daily dosing.

AbsorptionThe median time to reach maximum concentration (T max ) of dichlorphenamide was about 1.5 to 3 hours postdose after both single and multiple dose administrations.

DistributionThe plasma pro...

The efficacy of KEVEYIS was evaluated in two clinical studies, Study 1 and Study 2.

Study 1Study 1 was a 9-week, double blind, placebo-controlled multi-center study. Study 1 consisted of two substudies: a substudy in patients with hypokalemic periodic paralysis (n=44), and a substudy in patients with hyperkalemic periodic paralysis (n=21). The primary efficacy endpoint in both substudies was the average number of self-reported attacks of muscle weakness per week over the final 8 weeks of the trial. Withdrawal from the study for acute severe worsening (increase in attack frequency or severity)...

The following serious adverse reactions are described elsewhere in labeling: Hypersensitivity and Other Life-Threatening Reactions [see Warnings and Precautions (5.1) ] Hypokalemia [see Warnings and Precautions (5.3) ] Metabolic Acidosis [see Warnings and Precautions (5.4) ] Falls [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence at least 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state ( 6.1 ) To report SUSPECT...

KEVEYIS is contraindicated in the following circumstances: Hypersensitivity to dichlorphenamide or other sulfonamides [see Warnings and Precautions (5.1) ] Concomitant use of KEVEYIS and high dose aspirin [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ] Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS [see Warnings and Precautions (5.4) ] Hep...

Hypersensitivity and Other Life-Threatening Reactions: discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction ( 5.1 ) Hypokalemia: baseline and periodic measurements of serum potassium are recommended; if hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS and correcting potassium levels ( 5.3 ) Metabolic acidosis: baseline and periodic measurements of serum bicarbonate are recommended; if metabo...

7 DRUG INTERACTIONS Aspirin: anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. The concomitant use of KEVEYIS and high-dose aspirin is contraindicated. KEVEYIS should be used with caution in patients receiving lower doses of aspirin ( 4 , 5.2 , 7.1 ) 7.1 Aspirin and Other Salicylates Carbonic anhydrase inhibitors, including K...