Primary Periodic Paralysis

Primary periodic paralysis (PPP) is not easily diagnosed and may often go untreated for many years. It is characterized by muscle weakness that may be extreme and/or paralysis that may be localized (“focal”) or more widespread (“generalized”).1,2

In medical terms, primary periodic paralysis is referred to as a spectrum of chronic genetic, neuromuscular disorders with autosomal dominant inheritance.1-4

Primary periodic paralysis is very rare, affecting about 5,000 to 6,000 individuals in the US, or about 3 in every 200,000 people. The most common forms of the disease are hypokalemic and hyperkalemic primary periodic paralysis.5-9

Periodic Paralysis

The First and Only FDA-Approved Treatment:

KEVEYIS® (dichlorphenamide) 50 mg tablets is indicated for the treatment of:12

  • Primary hyperkalemic periodic paralysis
  • Primary hypokalemic periodic paralysis
  • Related variants

Important Safety Information

In clinical studies, the most common side effects of KEVEYIS were a numbness or tingling, difficulty thinking and paying attention, changes in taste, and confusion. These are not all of the possible side effects that you may experience with KEVEYIS. Talk to your doctor if you have any symptoms that bother you or do not go away.

KEVEYIS is not for everyone. Do not take KEVEYIS if you:

  • Are on a high-dose aspirin regimen
  • Are allergic to sulfa-based drugs
  • Have liver, kidney, or certain lung conditions
  • Are pregnant, planning to become pregnant, or nursing
  • Are under 18 years old

Taking KEVEYIS may cause a drop in the amount of potassium (an electrolyte) in your body, which can lead to heart problems. Ask your doctor if you need to eat foods that contain high amounts of potassium while taking KEVEYIS.

Your body may produce too much acid or may not be able to remove enough acid from body fluids while taking KEVEYIS. Your doctor will run tests on a regular basis to check for signs of acid buildup and may reduce your dose or stop your treatment with KEVEYIS.

KEVEYIS may also increase the risk of falls, especially in elderly patients and patients taking high doses of KEVEYIS. Use caution when driving, operating machinery, or performing any other hazardous activities while taking KEVEYIS, as this medication may cause drowsiness.

You are encouraged to report side effects to Strongbridge Biopharma at 1-855-324-8912, or to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch/. For more information, go to www.keveyis.com.

For additional KEVEYIS important safety information, please see full Prescribing Information (PDF).

References

  1. Grieg SL. Dichlorphenamide: a review in primary periodic paralyses. Drugs. 2016;76:501-507.
  2. Charles G, Zheng C, Lehmann-Horn F, Jurkatt-Rott, Levitt J. Characterization of hyperkalemic periodic paralysis: a survey of genetically diagnosed individuals. J Neurol. 2013;260:2606-2613.
  3. Fontaine B, Phillips LH. A newly approved drug for a rare group of diseases: dichlorphenamide for periodic paralysis. Neurology. 2016;86:1366-1367.
  4. Sansone V, Meola G, Links T, Panzeri M, Rose MR. Treatment for periodic paralysis (review). Cochrane Database Syst Rev. 2008; Jan 23;(1):CD005045.
  5. National Institutes of Health. Hyperkalemic periodic paralysis. https://ghr.nlm.nih.gov/condition/hyperkalemic-periodic-paralysis. Accessed December 5, 2016.
  6. National Institutes of Health. Hypokalemic periodic paralysis. https://ghr.nlm.nih.gov/condition/hypokalemic-periodic-paralysis. Accessed December 5, 2016.
  7. National Institutes of Health. Anderson-Tawil syndrome. https://ghr.nlm.nih.gov/condition/andersen-tawil-syndrome. Accessed December 5, 2016.
  8. National Institutes of Health. Potassium-aggravated myotonia. https://ghr.nlm.nih.gov/condition/potassium-aggravated-myotonia. Accessed December 5, 2016.
  9. National Institutes of Health. Paramyotonia congenita. https://ghr.nlm.nih.gov/condition/paramyotonia-congenita. Accessed December 5, 2016.
  10. Cannon SC. Channelopathies of skeletal muscle excitability. Compr Physiol. 2015;5:761-790
  11. 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.
  12. KEVEYIS® (dichlorphenamide) [package insert]. Trevose, PA: Strongbridge Biopharma; 2015.

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