KEVEYIS has a demonstrated tolerability profile
The most common adverse reactions with incidence ≥10% and rates greater than placebo in patients treated with KEVEYIS were paresthesia, cognitive disorder, dysgeusia, and confusional state.1
Adverse Reactions in Study 1
(≥5% and more common than in patients treated with placebo)
|Adverse Reaction||KEVEYIS (n=36)||Placebo (n=29)|
|Nervous system disorders||Paresthesia||44%||14%|
|General disorders and administration site conditions||Fatigue||8%||0%|
|Musculoskeletal and connective tissue disorders||Muscle spasms||8%||0%|
Discontinuation rates in patients treated with KEVEYIS
Less than 10% (3/36) of all patients treated with KEVEYIS withdrew due to an adverse reaction in the double-blind phase of Study 12†
- 17% of hyperkalemic patients (2/12) discontinued treatment2†
- ~4% (1/24) of hypokalemic patients discontinued treatment2†
- *Cognitive disorder combined cases with the preferred terms of cognitive disorder, disturbance in attention, and mental impairment.1
- †No patients treated with placebo withdrew due to an adverse reaction.
Flexible dosing of KEVEYIS allows for an individualized treatment approach1
Initiate 50 mg orally, once or twice daily1
Dosing can be increased or decreased at weekly intervals (or sooner in case of adverse reactions) based on individual response. The maximum recommended daily dose is 200 mg.
Monitor at weekly intervals1
Check in with your patients weekly to see if a dose adjustment is needed.
- You can lower the dose of KEVEYIS if your patient is experiencing adverse reactions
- You can also increase the dose of KEVEYIS to help further decrease the number, severity, and duration of your patient’s attacks
Evaluate overall response1
Continue to assess your patient’s response to KEVEYIS after 2 months of treatment to determine if additional dose titration is needed.
Patients already on KEVEYIS prior to entering Study 1 or Study 2 continued on the same dose. In patients taking acetazolamide prior to entering Study 1 or Study 2, the dose of KEVEYIS was 20% of the acetazolamide dose. Dose reduction for tolerability was permitted. Treatment-naive patients received 50 mg of KEVEYIS BID.