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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity / Anaphylaxis / Idiosyncratic reactions: discontinue KEVEYIS™ at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction ( 5.1 ) Hypokalemia: baseline and periodic measurement of serum potassium are recommended; if hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS™ ( 5.3 ) Metabolic acidosis: baseline and periodic measurement of serum bicarbonate are recommended; if metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS™ ( 5.4 ) Falls: consider reducing the dose or discontinuing KEVEYIS™ in patients who experience falls ( 5.5 ) 5.1 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. KEVEYIS™ should be discontinued at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction. 5.2 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. KEVEYIS™ should be used with caution in patients receiving low dose aspirin. 5.3 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 insufficiency, hyperchloremic metabolic acidosis, or respiratory acidosis), and in patients receiving other drugs that may cause hypokalemia (e.g., loop diuretics, thiazide diuretics, laxatives, antifungals, penicillin, and theophylline). Baseline and periodic measurement of serum potassium during KEVEYIS™ treatment are recommended. If hypokalemia develops or persists, consideration should be given to reducing the dose or discontinuing KEVEYIS™. 5.4 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 measurement of serum bicarbonate during KEVEYIS™ treatment are recommended. If metabolic acidosis develops or persists, consideration should be given to reducing the dose or discontinuing KEVEYIS™. 5.5 Falls KEVEYIS™ increases the risk of falls. The risk of falls is greater in the elderly and with higher doses of KEVEYIS™. Consider dose reduction or discontinuation of KEVEYIS™ in patients who experience falls while treated with KEVEYIS™.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: Hypersensitivity / Anaphylaxis / Idiosyncratic reactions [see Warnings and Precautions (5.1) ] Hypokalemia [see Warnings and Precautions (5.3) ] Metabolic Acidosis [see Warnings and Precautions (5.4) ] Falls [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence at least 10% and greater than placebo) include paresthesias, cognitive disorder, dysgeusia, and confusional state ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro at 1-866-923-4914, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 9-week randomized controlled trial in adults with hyperkalemic or hypokalemic periodic paralysis (Study 1), the most common adverse reactions in patients treated with KEVEYIS™, with rates greater than placebo, were paresthesia, cognitive disorder, dysgeusia, and confusional state. The mean dose of KEVEYIS™ was 94 mg/day in patients with hypokalemic periodic paralysis and 82 mg/day in patients with hyperkalemic periodic paralysis. Table 1 lists the incidence of adverse reactions that occurred in ≥ 5% of patients treated with KEVEYIS™ and more commonly than in patients treated with placebo in Study 1. Table 1: Adverse Reactions in Patients Treated with KEVEYIS™ with Incidence ≥ 5% and more common than in Patients Treated with Placebo in Study 1 Adverse Reaction KEVEYIS™ N = 36 (%) Placebo N = 29 (%) Nervous system disorders Paresthesia 44 14 Cognitive disorder Cognitive disorder combined cases with the preferred terms of cognitive disorder , disturbance in attention , and mental impairment . 14 7 Dysgeusia 14 0 Confusional state 11 0 Headache 8 7 Hypoesthesia 8 0 Lethargy 8 0 Dizziness 6 0 Gastrointestinal disorders Diarrhea 6 3 Nausea 6 0 General disorders and administration site conditions Fatigue 8 0 Malaise 6 0 Investigations Weight decreased 6 0 Musculoskeletal and connective tissue disorders Muscle spasms 8 0 Arthralgia 6 3 Muscle twitching 6 0 Respiratory Dyspnea 6 0 Pharyngolaryngeal pain 6 0 Skin Rash 8 0 Pruritus 6 0 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of dichlorphenamide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following are adverse reactions which have been reported for dichlorphenamide that were serious adverse events or are not reported in the previous section of labeling [see Clinical Trials Experience (6.1) ] : amnesia, cardiac failure, condition aggravated, convulsion, fetal death, hallucination, nephrolithiasis, pancytopenia, psychotic disorder, renal tubular necrosis, stupor, syncope, tremor.
adverse reactions table
<table width="90%"><caption>Table 1: Adverse Reactions in Patients Treated with KEVEYIS™ with Incidence ≥ 5% and more common than in Patients Treated with Placebo in Study 1</caption><col width="40%" align="left" valign="top"/><col width="20%" align="left" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule"/><th styleCode="Rrule">Adverse Reaction</th><th styleCode="Rrule">KEVEYIS™ N = 36 (%)</th><th styleCode="Rrule">Placebo N = 29 (%)</th></tr></thead><tbody><tr styleCode="Botrule"><td valign="middle" rowspan="8" styleCode="Lrule Rrule">Nervous system disorders</td><td styleCode="Rrule">Paresthesia</td><td styleCode="Rrule">44</td><td styleCode="Rrule">14</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Cognitive disorder<footnote>Cognitive disorder combined cases with the preferred terms of <content styleCode="italics">cognitive disorder</content>, <content styleCode="italics">disturbance in attention</content>, and <content styleCode="italics">mental impairment</content>.</footnote></td><td align="center" styleCode="Rrule">14</td><td styleCode="Rrule">7</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Dysgeusia</td><td align="center" styleCode="Rrule">14</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Confusional state</td><td align="center" styleCode="Rrule">11</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Headache</td><td align="center" styleCode="Rrule">8</td><td styleCode="Rrule">7</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Hypoesthesia</td><td align="center" styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Lethargy</td><td align="center" styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Dizziness</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td valign="top" rowspan="2" styleCode="Lrule Rrule">Gastrointestinal disorders</td><td styleCode="Rrule">Diarrhea</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">3</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Nausea</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td valign="middle" rowspan="2" styleCode="Lrule Rrule">General disorders and administration site conditions</td><td styleCode="Rrule">Fatigue</td><td styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Malaise</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Investigations</td><td styleCode="Rrule">Weight decreased</td><td styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td valign="middle" rowspan="3" styleCode="Lrule Rrule">Musculoskeletal and connective tissue disorders</td><td styleCode="Rrule">Muscle spasms</td><td styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Arthralgia</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">3</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Muscle twitching</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td rowspan="2" valign="middle" styleCode="Lrule Rrule">Respiratory</td><td styleCode="Rrule">Dyspnea</td><td styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Pharyngolaryngeal pain</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr><tr styleCode="Botrule"><td rowspan="2" valign="middle" styleCode="Lrule Rrule">Skin</td><td styleCode="Rrule">Rash</td><td styleCode="Rrule">8</td><td styleCode="Rrule">0</td></tr><tr><td styleCode="Rrule">Pruritus</td><td align="center" styleCode="Rrule">6</td><td styleCode="Rrule">0</td></tr></tbody></table>