dofetilide

Generic Name: dofetilide (doe FET i lide)
Brand Name: Tikosyn

What is dofetilide?

Dofetilide is a heart rhythm medicine, also called an antiarrhythmic.

Dofetilide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Dofetilide is used in people with atrial fibrillation or atrial flutter.

Dofetilide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dofetilide?

You should not take dofetilide if you have severe kidney disease or a history of Long QT syndrome.

You will need to spend at least 3 days in a hospital setting when you first start taking dofetilide. This is so your heart rhythm and kidney function can be monitored in case the medicine causes serious side effects.

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What should I discuss with my health care provider before taking dofetilide?

You should not take dofetilide if you are allergic to it, or if you have:

  • severe kidney disease (or if you are on dialysis); or

  • a history of Long QT syndrome.

Some medicines can cause unwanted or dangerous effects when used with dofetilide, and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cimetidine;

  • dolutegravir;

  • ketoconazole;

  • megestrol;

  • prochlorperazine;

  • trimethoprim (Proloprim, Trimpex, Bactrim, Septra);

  • verapamil; or

  • a diuretic (water pill) that contains hydrochlorothiazide (HCTZ), such as Accuretic, Aldactazide, Atacand HCT, Benicar HCT, Diovan HCT, Dyazide, Exforge HCT, Hyzaar, Lopressor HCT, Maxzide, Micardis HCT, Monopril HCT, Prinzide, Tekturna HCT, Vaseretic, and others.

To make sure dofetilide is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure;

  • liver or kidney disease;

  • depression, mental illness;

  • asthma or allergies;

  • any active infection;

  • skin problems; or

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

FDA pregnancy category C. It is not known whether dofetilide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether dofetilide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using dofetilide.

How should I take dofetilide?

Dofetilide is available only from a hospital or specialty pharmacy.

You will need to spend at least 3 days in a hospital setting when you first start taking dofetilide. This is so your heart rhythm and kidney function can be monitored in case the medicine causes serious side effects.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take dofetilide with or without food.

You should not skip doses or stop using dofetilide suddenly. Stopping suddenly may make your condition worse. Follow your doctor's instructions about tapering your dose.

Tell your doctor if you have a prolonged illness that causes severe diarrhea, vomiting, or heavy sweating. These conditions can cause an electrolyte imbalance, making it dangerous for you to use dofetilide.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked with frequent blood tests.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking dofetilide?

Grapefruit and grapefruit juice may interact with dofetilide and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Dofetilide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • loss of appetite, vomiting or severe diarrhea; or

  • low magnesium or potassium--confusion, uneven heart rate, increased thirst or urination, sweating, jerking muscle movements, leg discomfort, muscle weakness or limp feeling.

Common side effects may include:

  • mild headache;

  • mild dizziness; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

Dofetilide dosing information

Usual Adult Dose for Arrhythmias:

125 mcg once a day to 500 mcg twice a day
Dose is based on creatinine clearance and QTc interval prolongation. Dose is adjusted 2 to 3 hours after first dose based QTc interval.

First dose:
Creatinine clearance (Clcr) must be at least 20 mL/min.
Clcr = 20 to less than 40 mL/min =125 mcg twice a day
Clcr = 40 to 60 mL/min =250 mcg twice a day
Clcr greater than 60 mL/min = 500 mcg twice a day

Second dose - based on QTc interval increase:
15 % or less increase = continue dosage
greater than 15% increase = decrease dose as follows:
if first dose was 500 mcg BID, then use 250 mcg BID;
if first dose was 250 mcg BID, then use 125 mcg BID;
if first dose was 125 mcg BID, then use 125 mcg once a day.
If at any time QTc becomes greater the 500 msec (550 msec in patient with ventricular conduction abnormalities), drug should be discontinued.

What other drugs will affect dofetilide?

Other drugs may interact with dofetilide, 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.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about dofetilide.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.03. Revision Date: 2014-01-23, 11:15:33 AM.

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