KEVEYIS®
VISIT AAN BOOTH 889 AND LEARN MORE ABOUT KEVEYIS, the first and only FDA-approved treatment for Primary Periodic Paralysis (PPP)
Primary periodic paralysis is a group of rare neuromuscular disorders that can cause recurrent, progressive, and debilitating episodes of muscle weakness and temporary paralysis that may negatively impact patients’ daily lives.1-4
Please visit Strongbridge Biopharma at Booth 889 at the American Academy of Neurology (AAN) Annual Meeting to learn more about KEVEYIS—and find out how this FDA-approved treatment can help patients gain greater control over their disease by decreasing the number, severity, and duration of attacks.5,6
For more information about KEVEYIS for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis, please visit KEVEYIS.com
Please click here for Full Prescribing Information
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.
Indication
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
Please click here for 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. KEVEYIS Prescribing Information. Feasterville-Trevose, PA: Strongbridge Biopharma; 2017.
  6. 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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Strongbridge Biopharma KEVEYIS®
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United States
www.KEVEYIS.com
www.strongbridgebio.com

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STRONGBRIDGE BIOPHARMA™ is a trademark of Strongbridge Biopharma plc.
KEVEYIS® is a registered trademark licensed exclusively in the US to Strongbridge Biopharma

KEV057-01 04/2017