Keveyis

Last updated on RxList: 12/21/2017
Keveyis Side Effects Center

Last reviewed on RxList 12/21/2017

Keveyis (dichlorphenamide) is an oral carbonic anhydrase inhibitor indicated for the treatment of primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. Common side effects of Keveyis include tingling or pricking sensations, cognitive disorder, changes in the sense of taste, confusion, headache, numbness, lethargy, dizziness, diarrhea, nausea, fatigue, malaise, weight loss, muscle spasms or twitching, joint pain, indigestion, throat pain, rash, or itching.

The initial dose of Keveyis is 50 mg twice daily. The maximum recommended dose of Keveyis is 200 mg daily. Keveyis may interact with aspirin. Tell your doctor all medications and supplements you use. Keveyis is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Keveyis passes into breast milk. Consult your doctor before breastfeeding.

Our Keveyis (dichlorphenamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Keveyis Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;
  • an accidental fall;
  • worsening of your paralysis symptoms;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • signs of too much acid in your blood--irregular heartbeats, feeling tired, loss of appetite, trouble thinking, feeling short of breath.

Accidental falls are more likely in older adults or in people who take high doses of Dichlorphenamide. Use caution to avoid falling or accidental injury while you are taking this medicine.

Common side effects may include:

  • drowsiness;
  • confusion;
  • numbness or tingling; or
  • altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Keveyis (Dichlorphenamide Tablets)

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Keveyis Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in labeling:

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 disorder1 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
1Cognitive disorder combined cases with the preferred terms of cognitive disorder, disturbance in attention, and mental impairment.

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]: amnesia, cardiac failure, condition aggravated, convulsion, fetal death, hallucination, nephrolithiasis, pancytopenia, psychotic disorder, renal tubular necrosis, stupor, syncope, tremor.

Read the entire FDA prescribing information for Keveyis (Dichlorphenamide Tablets)

© Keveyis Patient Information is supplied by Cerner Multum, Inc. and Keveyis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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