Keveyis
(Dichlorphenamide)By using PrescriberAI, you agree to the AI Terms of Use.
Keveyis Prescribing Information
KEVEYIS is indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants.
Round, white tablets, scored on one side, engraved with "D" above the score and "50" below the score, the other side is plain, 50 mg each.
Pregnancy: Based on animal data, may cause fetal harm (
There are no adequate data on the developmental risk associated with the use of KEVEYIS in pregnant women. A no-effect dose has not been established. Dichlorphenamide was teratogenic when administered orally to pregnant rats.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively.
KEVEYIS treatment can cause metabolic acidosis
Although the effect of KEVEYIS on labor and delivery in humans has not been established, the development of dichlorphenamide-induced metabolic acidosis in the mother and/or in the fetus might affect the fetus’ ability to tolerate labor.
Teratogenic effects (fetal limb reduction defects) were reported following oral administration of dichlorphenamide to pregnant rats during organogenesis at 350 mg/kg, or 17 times the maximum recommended human dose (200 mg/day) on a body surface area (mg/m2) basis. A no-effect dose for adverse effects on embryofetal development has not been established.
KEVEYIS is contraindicated in the following circumstances:
- Hypersensitivity to dichlorphenamide or other sulfonamides [see]
5.1 Hypersensitivity and Other Life-Threatening ReactionsFatalities 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.
KEVEYIS should be discontinued at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction.
- Concomitant use of KEVEYIS and high dose aspirin [seeand
5.2 Concomitant Use of Aspirin or Other SalicylatesCarbonic anhydrase inhibitors, including KEVEYIS, can cause metabolic acidosis
[see Warnings and Precautions (5.4)], 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. Therefore, the concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Patients with concomitant use of KEVEYIS and low-dose aspirin should be carefully monitored.]7.1 Aspirin and Other SalicylatesCarbonic anhydrase inhibitors, including KEVEYIS, can cause metabolic acidosis
[see Warnings and Precautions ( 5.2, 5.4 )],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. Therefore, concomitant use of KEVEYIS and high-dose aspirin is contraindicated. Patients with concomitant use of KEVEYIS and low-dose aspirin should be carefully monitored[see Contraindications (4)and Warnings and Precautions (5.2)]. - Severe pulmonary disease, limiting compensation to metabolic acidosis caused by KEVEYIS [see]
5.4 Metabolic AcidosisKEVEYIS 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, consideration should be given to reducing the dose or discontinuing KEVEYIS
[see Drug Interactions (7.4)]. - Hepatic insufficiency: KEVEYIS may aggravate hepatic encephalopathy.
- Hypersensitivity and Other Life-Threatening Reactions: discontinue KEVEYIS at the first appearance of skin rash or any sign of immune-mediated or idiosyncratic adverse reaction ()
5.1 Hypersensitivity and Other Life-Threatening ReactionsFatalities 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.
KEVEYIS should be discontinued at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction.
- Hypokalemia: baseline and periodic measurements of serum potassium are recommended; if hypokalemia develops or persists, consider reducing the dose or discontinuing KEVEYIS and correcting potassium levels ()
5.3 HypokalemiaKEVEYIS 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
[see Drug Interactions (7.3)].Baseline and periodic measurements of serum potassium during KEVEYIS treatment is recommended.
If hypokalemia develops or persists, consideration should be given to reducing the dose or discontinuing KEVEYIS and correction of potassium levels.
- Metabolic acidosis: baseline and periodic measurements of serum bicarbonate are recommended; if metabolic acidosis develops or persists, consider reducing the dose or discontinuing KEVEYIS ()
5.4 Metabolic AcidosisKEVEYIS 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, consideration should be given to reducing the dose or discontinuing KEVEYIS
[see Drug Interactions (7.4)]. - Falls: consider reducing the dose or discontinuing KEVEYIS in patients who experience falls ()
5.5 FallsKEVEYIS 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.
The following serious adverse reactions are described elsewhere in labeling:
- Hypersensitivity and Other Life-Threatening Reactions [see]
5.1 Hypersensitivity and Other Life-Threatening ReactionsFatalities 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.
KEVEYIS should be discontinued at the first appearance of skin rash or any sign of immune-mediated or other life-threatening adverse reaction.
- Hypokalemia [see]
5.3 HypokalemiaKEVEYIS 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
[see Drug Interactions (7.3)].Baseline and periodic measurements of serum potassium during KEVEYIS treatment is recommended.
If hypokalemia develops or persists, consideration should be given to reducing the dose or discontinuing KEVEYIS and correction of potassium levels.
- Metabolic Acidosis [see]
5.4 Metabolic AcidosisKEVEYIS 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, consideration should be given to reducing the dose or discontinuing KEVEYIS
[see Drug Interactions (7.4)]. - Falls [see]
5.5 FallsKEVEYIS 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.