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Dofetilide

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

Dofetilide may cause new irregular heart rhythms (arrhythmias). To reduce this risk, you must stay in a facility with appropriate monitoring equipment for at least the first 3 days of therapy.


Dofetilide is used for:

Treating specific types of irregular heartbeat (atrial fibrillation or atrial flutter) in certain patients. It may also be used for other conditions as determined by your doctor.

Dofetilide is an antiarrhythmic. It works by helping the heart to regain a normal rhythm.

Do NOT use dofetilide if:

  • you are allergic to any ingredient in dofetilide
  • you have severe kidney problems or you are on dialysis
  • you have a certain type of irregular heartbeat (QT prolongation)
  • you are taking asenapine, cimetidine, cisapride, dolutegravir, ketoconazole, a macrolide antibiotic (eg, clarithromycin, erythromycin), megestrol, nilotinib, certain phenothiazines (eg, chlorpromazine, prochlorperazine, thioridazine), tetrabenazine, a thiazide diuretic (eg, hydrochlorothiazide), trimethoprim, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

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Before using dofetilide:

Some medical conditions may interact with dofetilide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart problems (eg, other types of irregular heartbeat), kidney problems, liver problems, or low magnesium or potassium levels in your blood
  • if you have previously taken another antiarrhythmic (eg, amiodarone, sotalol)

Some MEDICINES MAY INTERACT with dofetilide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for allergies, asthma, cancer, depression or other mental or mood problems, diabetes, heartburn, hepatitis C, high blood pressure, HIV infection, immune system suppression, infections, irregular heartbeat or other heart problems, loss of appetite, multiple sclerosis, nausea and vomiting, pain, swelling, Tourette disorder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with dofetilide.

This may not be a complete list of all interactions that may occur. Ask your health care provider if dofetilide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dofetilide:

Use dofetilide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dofetilide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get dofetilide refilled.
  • Take dofetilide by mouth with or without food.
  • Check with your doctor before you eat grapefruit or drink grapefruit juice while you use dofetilide.
  • Dofetilide works best if it is taken at the same time each day.
  • Continue to use dofetilide even if you feel well. Do not miss any doses.
  • If you miss a dose of dofetilide, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use dofetilide.

Important safety information:

  • Dofetilide may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use dofetilide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Tell your doctor or dentist that you take dofetilide before you receive any medical or dental care, emergency care, or surgery.
  • Do NOT change your dose of dofetilide or stop taking it without checking with your doctor.
  • If loss of appetite; increased thirst; or severe or persistent vomiting, sweating, or diarrhea occur, electrolyte problems may occur. Contact your doctor for instructions if you experience any of these effects.
  • Lab tests, including electrocardiograms (ECG), kidney function, and potassium and magnesium blood tests, may be performed while you use dofetilide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dofetilide should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using dofetilide while you are pregnant. It is not known if dofetilide is found in breast milk. Do not breast-feed while taking dofetilide.

Possible side effects of dofetilide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; symptoms of respiratory tract infection (eg, cough, mild fever, sneezing, sore throat).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); anxiety; burning, numbness, or tingling; chest, jaw, or arm pain; confusion; difficult or painful urination; fainting; fast, slow, or irregular heartbeat; inability to move (including the face); one-sided weakness; severe or persistent headache; shortness of breath; slurred speech; sudden, severe nausea or vomiting; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, unusual tiredness, yellowing of the skin or eyes); unusual sweating; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular heartbeat.

Proper storage of dofetilide:

Store dofetilide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep dofetilide out of the reach of children and away from pets.

General information:

  • If you have any questions about dofetilide, please talk with your doctor, pharmacist, or other health care provider.
  • Dofetilide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take dofetilide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dofetilide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dofetilide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using dofetilide.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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