Keveyis

1. Keveyis

Dosage Forms & Strengths

tablet

• 50mg

Periodic Paralysis

Indicated for primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants

50 mg PO q12hr; increase or decrease at weekly intervals according to individual response; not to exceed 200 mg/day

Evaluate patient response after 2 months of treatment to decide drug should be continued

Safety and efficacy not established

Periodic Paralysis

Indicated for primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants

50 mg PO q12hr; increase or decrease at weekly intervals according to individual response; not to exceed 200 mg/day

Evaluate patient response after 2 months of treatment to decide whether drug should be continued

Use lowest effective dose possible, owing to risk increased risk of falls

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aspirin (including baby aspirin);
• digoxin;
• penicillin;
• theophylline;
• antifungal medicine;
• a laxative; or
• a diuretic or "water pill."

Other drugs may interact with dichlorphenamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Inhibits carbonic anhydrase.1 3 7 8

• Precise mechanism of action in periodic paralysis is unknown, but may be related to the drug's ability to reduce potassium concentrations, induce metabolic acidosis, and/or activate calcium-activated potassium channels.1 4 5 7 9 10 12 15

• Pharmacologic actions are similar to those of other carbonic anhydrase inhibitors.7

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dichlorphenamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dichlorphenamide in the elderly. However, elderly patients are more likely to have falls or metabolic acidosis, which may require caution in patients receiving dichlorphenamide.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aspirin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal problems or
• Hyperchloremic metabolic acidosis or
• Respiratory acidosis—May increase risk for hypokalemia.

• Allergy to sulfa drugs or
• Liver disease or
• Lung disease, severe—Should not be used in patients with these conditions.

• Tell all of your health care providers that you take this medicine (Keveyis). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• The chance of falling is raised with this medicine (Keveyis). The chance of falling is higher in older people and with higher doses of this medicine. Talk with the doctor.
• If you are 65 or older, use this medicine (Keveyis) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Initiate dosing at 50 mg twice daily. The initial dose may be increased or decreased based on individual response, at weekly intervals (or sooner in case of adverse reaction). The maximum recommended total daily dose is 200 mg.

Primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants are a heterogeneous group of conditions, for which the response to Keveyis may vary. Therefore, prescribers should evaluate the patient's response to Keveyis after 2 months of treatment to decide whether Keveyis should be continued.

Keveyis is contraindicated in the following circumstances:

• Hypersensitivity to dichlorphenamide or other sulfonamides [see Warnings and Precautions (5.1)]
• Concomitant use of Keveyis and high dose aspirin [see Warnings and Precautions (5.2)]
• Severe pulmonary disease, limiting compensation to metabolic acidosis caused by Keveyis [see Warnings and Precautions (5.4)]
• Hepatic insufficiency: Keveyis may aggravate hepatic encephalopathy.

Symptoms of overdosage or toxicity may include drowsiness, anorexia, nausea, vomiting, dizziness, paresthesias, ataxia, tremor, and tinnitus.

In the event of overdosage, induce emesis or perform gastric lavage. The electrolyte disturbance most likely to be encountered from overdosage is hyperchloremic acidosis.

NDC 71090-001-01
100 Tablets

Keveyis®
(dichlorphenamide)
Tablets 50 mg

Keep this and all medications out
of the reach of children.
Rx only