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Indication
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KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
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Important Safety Information
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Contraindications
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Hypersensitivity to dichlorphenamide or other sulfonamides |
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Concomitant use of KEVEYIS and high-dose aspirin |
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Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS |
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Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy |
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Warnings and Precautions
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Hypersensitivity and Other Life-Threatening Reactions
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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. |
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Pulmonary involvement can occur in isolation or as part of a systemic reaction. |
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Discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction. |
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Concomitant Use of Aspirin or Other Salicylates
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Carbonic anhydrous inhibitors, including KEVEYIS, can cause metabolic acidosis, which can increase the risk of salicylate toxicity. |
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Anorexia, tachypnea, lethargy, and coma have been reported with concomitant use of dichlorphenamide and high-dose aspirin. |
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Concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Use with caution and carefully monitor in patients receiving low-dose aspirin. |
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Hypokalemia
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KEVEYIS increases potassium excretion and can cause hypokalemia. |
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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). |
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Baseline and periodic measurements of serum potassium are recommended. |
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If hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS and correction of potassium levels. |
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Metabolic Acidosis
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KEVEYIS can cause hyperchloremic non-anion gap metabolic acidosis. |
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Concomitant use of KEVEYIS with other drugs that cause metabolic acidosis may increase the severity of acidosis. |
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Concomitant use of KEVEYIS in compensated patients with respiratory acidosis, such as in advanced lung diseases, may lead to respiratory decompensation. |
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Baseline and periodic measurements of serum bicarbonate during KEVEYIS treatment are recommended. |
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If metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS. |
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Falls
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KEVEYIS increases the risk of falls; risk is greater in the elderly and with higher doses. |
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Consider dose reduction or discontinuation of KEVEYIS in patients who experience falls while treated with KEVEYIS. |
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Pregnancy and Lactation
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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.
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Adverse Reactions
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The most common adverse reactions seen in clinical trials (incidence ≥ 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state.
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Please see Full Prescribing Information.
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