Strongbridge Biopharma
KEVEYIS® (dichlorphenamide) is the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis
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KEVEYIS® (dichlorphenamide) is the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis
Primary Periodic Paralysis is a Rare and Debilitating Condition
Primary periodic paralysis (PPP) causes recurrent, progressive, and debilitating episodes of muscle weakness and temporary paralysis that impact patients’ daily lives.1-4
Although there are related variants, the most common forms are hyperkalemic and hypokalemic periodic paralysis.5-9
Learn more about the diagnosis and management of PPP, a complex and challenging disorder →
Helping to Turn Limitation Into Activation
Proven in 2 clinical studies, KEVEYIS is helping patients gain greater control over PPP by decreasing the number, severity, and duration of attacks.10,11
Attacks per week (defined as weekly attack rate) was the primary efficacy measure in Study 1.10*
  • Hyperkalemic Periodic Paralysis Substudy of Study 1: Patients treated with KEVEYIS (n=12) had 3.9 fewer attacks per week than patients (n=9) treated with placebo (P=0.08)10
  • Hypokalemic Periodic Paralysis Substudy of Study 1: Patients treated with KEVEYIS (n=24) had 2.2 fewer attacks per week than patients (n=20) treated with placebo (P=0.02)10
*Treatment effect equals KEVEYIS attack rate per week minus placebo attack rate per week; adjusted for missing diary days. This was captured by daily telephone report to an electronic diary (interactive voice response). Treatment effect is computed as the median of the bootstrap distribution of treatment group difference in median response. The 95% confidence interval (CI) is computed using the 2.5 and 97.5 percentiles of this bootstrap distribution.
Learn more about the results of treatment with KEVEYIS and its effect on the number, severity, and duration of attacks →
KEVEYIS has a demonstrated safety profile10
The most common adverse reactions (incidence at least 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.10
For more information about starting your patients on KEVEYIS, visit KEVEYIS.com →
Strongbridge Biopharma
Indication
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
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.
For Important Safety Information, please see full Prescribing Information →
References:
  1. Charles G, Zheng C, Lehmann-Horn F, Jurkat-Rott K, Levitt J. Characterization of hyperkalemic periodic paralysis: a survey of genetically diagnosed individuals. J Neurol. 2013;260:2606-2613.
  2. Arya SN. Periodic paralysis. Journal, Indian Academy of Clinical Medicine. 2002;3:374-382.
  3. Cannon SC. Channelopathies of skeletal muscle excitability. Compr Physiol. 2015;5:761-790.
  4. Cavel-Greant D, Lehmann-Horn F, Jurkat-Rott K. The impact of permanent muscle weakness on quality of life in periodic paralysis: a survey of 66 patients. Acta Myol. 2012;31:126-133.
  5. National Institutes of Health. Hyperkalemic periodic paralysis. Available at: https://ghr.nlm.nih.gov/condition/hyperkalemic-periodic-paralysis. Accessed December 5, 2016.
  6. National Institutes of Health. Hypokalemic periodic paralysis. Available at: https://ghr.nlm.nih.gov/condition/hyperkalemic-periodic-paralysis. Accessed December 5, 2016.
  7. National Institutes of Health. Anderson-Tawil syndrome. Available at: https://ghr.nlm.nih.gov/condition/andersen-tawil-syndrome. Accessed December 5, 2016.
  8. National Institutes of Health. Potassium-aggravated myotonia. Available at: https://ghr.nlm.nih.gov/condition/potassium-aggravated-myotonia. Accessed December 5, 2016.
  9. National Institutes of Health. Paramyotonia congenita. Available at: https://ghr.nlm.nih.gov/condition/paramyotonia-congenita. Accessed December 5, 2016.
  10. KEVEYIS Prescribing Information. Feasterville-Trevose, PA: Strongbridge Biopharma; 2017.
  11. Sansone VA, Burge J, McDermott MP, et al; for the Muscle Study Group. Randomized, placebo-controlled trials of dichlorphenamide in periodic paralysis. Neurology. 2016;86:1408-1416.
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United States
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