Important Safety Information

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COMPLIMENTARY SUPPORT Xeris CareConnection™: Redefining the experience for you and your patients Learn about a range of free support services to help empower the PPP community. “>”>How we can help your practice Navigating Primary Periodic Paralysis (PPP) treatment can feel like uncharted territory. Our team of PPP experts work with your practice and patients to […]

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COMPLIMENTARY SUPPORT Discover PPP MentorConnect™ PPP MentorConnect puts PPP patients and their caregivers in touch with another person taking KEVEYIS who may understand their experience and can offer valuable insights. Our dedicated Patient Access Managers can also help facilitate these connections to provide patients with an extra layer of personalized guidance and community. Meet our […]

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LIVING WITH PPP Patient Stories See why people choose KEVEYIS. Dennis Dennis was 14 when he had his first PPP episode. See how it changed his life, and how he handled the diagnosis.   Watch his story Janine Janine lived with an incorrect diagnosis for 10 years. Learn about her path to receiving the right […]

Tools and Resources

Tools and resources for healthcare providers PPP White Papers Insurance coverage Other Get helpful information on PPP, from diagnosis to treatment The Diagnostic Journey Learn about Primary Periodic Paralysis (PPP) clinical characteristics, subtype classification, neurophysiology, and review an established diagnostic algorithm to reach a diagnosis. Download now Impact on a PPP Patient’s Life Learn about […]

Managing Someone on KEVEYIS

Managing patients on KEVEYIS® KEVEYIS can be dosed at 50mg once or twice daily.1 However, it may take up to 9 weeks for your patient to find their individual therapeutic dose. Always review the full prescribing information before starting a patient on KEVEYIS. Titration and management guidance1 When starting KEVEYIS, keep in touch with your […]

Prescribing Keveyis

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Diagnosis and Management

Primary Periodic Paralysis: Helping to simplify a complex diagnosis. Every patient’s journey to a Primary Periodic Paralysis (PPP) diagnosis is different. The established diagnostic protocol can help speed up the path to treatment. On average, it can take 20+ years to receive a diagnosis2 PPP often has nonspecific and episodic symptoms that mimic those of […]

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INDICATION AND IMPORTANT SAFETY INFORMATION — READ MORE

Indication and Important Safety Information

 

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 and Other Life-Threatening Reactions

  • Fatalities associated with the administration of sulfonamides have occurred because of 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 other life-threatening adverse reaction.

 

Concomitant Use of Aspirin or Other Salicylates

  • Carbonic anhydrous inhibitors, including KEVEYIS, can cause metabolic acidosis, which can increase the risk of salicylate toxicity.
  • Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin.
  • Concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Use with caution and carefully monitor 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 (e.g., adrenocortical excess, renal tubular acidosis type 1 and 2), and in patients receiving other drugs that may cause hypokalemia (e.g., 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 and correction of potassium levels.

 

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 acidosis.
  • Concomitant use of KEVEYIS in compensated patients with respiratory acidosis, such as in advanced lung diseases, may lead to respiratory decompensation.
  • Baseline and periodic measurements of serum bicarbonate during KEVEYIS treatment 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.

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