KEVEYIS®: Treatment for Primary Periodic Paralysis

KEVEYIS (dichlorphenamide), granted orphan drug designation, is the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis—an ultra-rare neuromuscular disorder.1

KEVEYIS Has Been Proven to Reduce Attacks in 2 Clinical Studies vs Placebo

KEVEYIS was shown to reduce the number, duration, and severity of attacks of primary periodic paralysis.1

Results in Study 1: Hypokalemic patients treated with KEVEYIS had 2.2 fewer attacks per week than patients treated with placebo. Hyperkalemic patients treated with KEVEYIS had 3.9 fewer attacks per week than patients treated with placebo.1

Results in Study 2: 2.3 fewer weekly attacks vs placebo in the hyperkalemic periodic paralysis substudy.1

Within the hypokalemic subset, the primary endpoint was the occurrence of an intolerable increase in attack frequency or severity, necessitating withdrawal from the treatment phase. Acute intolerable worsening was observed in 2 patients on KEVEYIS vs 11 patients on placebo.

KEVEYIS Is Well Tolerated

The most common adverse reactions in patients treated with KEVEYIS, with rates greater than placebo, were paresthesia, cognitive disorder, dysgeusia, and confusional state.1

KEVEYIS Is Taken Twice a Day

KEVEYIS is provided as a 50 mg tablet with twice-daily dosing and the ability to adjust the dose based on individual patient response.

Questions about KEVEYIS?

If you are a patient or healthcare provider with questions about how to fill a prescription for KEVEYIS (dichlorphenamide), or if you have any other questions related to KEVEYIS, call 844-KEVEYIS or fax to 844-KEV-1030.

KEVEYIS® Indication

KEVEYIS® is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.1

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).

Reference

  1. KEVEYIS® (dichlorphenamide) [package insert]. Trevose, PA: Strongbridge Biopharma plc; 2016.

© 2016 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA is a trademark of Strongbridge Biopharma plc.
KEVEYIS® is a registered trademark licensed exclusively in the US to Strongbridge Biopharma plc.
MLR010 V7 12/2016

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