Help reduce attacks of muscle weakness and temporary paralysis in your PPP patients
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Prescribing Information    |    Important Safety Information
Indication
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
Please see Important Safety Information below.
Study Design*†1,2: Study 1 was a 9-week, double-blind, parallel-group, placebo-controlled, multicenter study that consisted of 2 substudies: hyperkalemic periodic paralysis (n=21) and hypokalemic periodic paralysis (n=44). The primary endpoint was the average number of self-reported attacks of muscle weakness, per week, the last 8 weeks of the study. The most common adverse reactions seen in the clinical trials (incidence ≥10% and greater than placebo) included paresthesias, cognitive disorder, dysgeusia, and confusional state. The double-blind phase was followed by a 1-year, open-label extension phase in which all participants received KEVEYIS.
Attack Rate of Zero (0) at 1 Year for Patients Who Started and Stayed on KEVEYIS1
Median Attack Rate Continued to Decline in Patients Who Remained on Treatment With KEVEYIS1
Are there adult patients in your practice suffering from the
debilitating symptoms of PPP?

Start appropriate patients on KEVEYIS with a
KEVEYIS Start Form
 
Contact your Area Business Specialist
[First, Last - ABS@strongbridgebio.com]
to schedule a discussion about KEVEYIS.
Important Safety Information
Contraindications
• Hypersensitivity to dichlorphenamide or other sulfonamides
• Concomitant use of KEVEYIS and high-dose aspirin
• Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS
• Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy
Warnings and Precautions
Hypersensitivity/Anaphylaxis/Idiosyncratic Reactions
• Fatalities associated with the administration of sulfonamides have occurred due to adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias.
• Pulmonary involvement can occur in isolation or as part of a systemic reaction.
• Discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction.
Concomitant Use of 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.
• Use with caution in patients receiving low-dose aspirin.
Hypokalemia
• KEVEYIS increases potassium excretion and can cause hypokalemia.
• The risk of hypokalemia is greater when KEVEYIS is used in patients with conditions associated with hypokalemia (eg, adrenocortical insufficiency, hyperchloremic metabolic acidosis, or respiratory acidosis), and in patients receiving other drugs that may cause hypokalemia (eg, loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline).
• Baseline and periodic measurements of serum potassium are recommended.
• If hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS.
Metabolic Acidosis
• KEVEYIS can cause hyperchloremic non–anion gap metabolic acidosis.
• Concomitant use of KEVEYIS with other drugs that cause metabolic acidosis may increase the severity of metabolic acidosis.
• Baseline and periodic measurements of serum bicarbonate are recommended.
• If metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS.
Falls
• KEVEYIS increases the risk of falls; risk is greater in the elderly and with higher doses.
• Consider dose reduction or discontinuation of KEVEYIS in patients who experience falls while treated with KEVEYIS.
Pregnancy and Lactation
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known in humans whether dichlorphenamide is excreted in human milk; exercise caution when administered to a nursing woman.
Adverse Reactions
The most common adverse reactions seen in clinical trials (incidence ≥ 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.
Please see Full Prescribing Information.
References: 1. Sansone VA, Burge J, McDermott MP, et al. Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis. Neurology. 2016;86:1408-1416. 2. KEVEYIS [package insert]. Feasterville-Trevose, PA: Strongbridge Biopharma; 2017.
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KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies,
which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.
KEV-0427          10/2018