Tikosyn
Dofetilide
Dofetilide (doe FET il ide) is a generic medication prescribed for heart rhythm problems called atrial fibrillation (AFib) and atrial flutter in adults. Dofetilide belongs to a group of drugs called antiarrhythmics.
Dofetilide (doe FET il ide) is a generic medication prescribed for heart rhythm problems called atrial fibrillation (AFib) and atrial flutter in adults. Dofetilide belongs to a group of drugs called antiarrhythmics.
- Generic
- • Capsule
- • 250mcg
- • 60 Capsules
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Intro
Introduction
Written by Sarah Lewis, PharmD
Medically reviewed by Brittany A. Duke, PharmD, RPh
Updated on August 18, 2023
Dofetilide (doe FET il ide) is a generic medication prescribed for heart rhythm problems called atrial fibrillation (AFib) and atrial flutter in adults. Dofetilide belongs to a group of drugs called antiarrhythmics.
Boxed warning: Risk of arrhythmia
Dofetilide oral capsule has a boxed warning about the risk of arrhythmia (heart rhythm problems). Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
For details, see the “Interactions and warnings for dofetilide” section.
Side effects
Side effects of dofetilide
Dofetilide may cause mild or serious side effects. More common mild side effects of dofetilide and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.
To learn more about dofetilide’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for dofetilide listed in the “Resources” section.
Mild side effects
More common mild side effects reported with dofetilide are listed below.
This article doesn’t include all possible mild side effects of the drug. To learn more about dofetilide’s side effects, refer to the prescribing information for dofetilide listed in the “Resources” section.
With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects bother you, tell your doctor or pharmacist. They may be able to suggest ways to manage them.
Dofetilide oral capsule’s mild side effects include:
- chest pain
- dizziness
- headache
- nausea
- mild allergic reaction*
* For details about this side effect, see the “Interactions and warnings for dofetilide” section.
Serious side effects
Serious side effects of dofetilide are listed below.
This article doesn’t include all possible serious side effects of the drug. To learn more about dofetilide’s side effects, refer to the prescribing information for dofetilide listed in the “Resources” section.
With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.
In general, dofetilide’s serious side effects include:
- cardiac arrest
- decreased blood flow to the brain
- fainting
- heart attack
- liver damage
- paralysis, which can include paralysis of the face
- slow heart rate
- stroke
- sudden death
- boxed warning: risk of arrhythmia (heart rhythm problems)*
- severe allergic reaction*
* For details about this side effect, see the “Interactions and warnings for dofetilide” section.
Interactions and warnings
Interactions and warnings for dofetilide
Below, you’ll find information about dofetilide’s possible interactions and warnings.
Interactions of dofetilide
Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.
Before you take dofetilide, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:
- prescription or over-the-counter drugs
- vitamins, herbs, or supplements
To learn about drug-condition interactions, see the “Warnings for dofetilide” section below.
Warnings for dofetilide
Some people should not take dofetilide, and others should take it cautiously.
Boxed warning: Risk of arrhythmia
Dofetilide has a boxed warning about the risk of arrhythmia (heart rhythm problems). Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).
With dofetilide, there is a risk of developing a serious ventricular arrhythmia. (The ventricles are the lower chambers of the heart.) This includes a potentially fatal type of arrhythmia called Torsade de Pointes (TdP). Due to this risk, you must be in the hospital to start or restart dofetilide. Your stay will last at least 3 days. This allows doctors to monitor drug levels, your kidney function, and your heart’s electrical activity.
TdP was uncommonly reported in studies of dofetilide. However, it became more common at higher doses. The risk is also higher with kidney disease and certain drug interactions.
About half of the people who develop TdP do not experience symptoms. When symptoms do occur, they may include dizziness, fainting, and heart palpitations (fast or pounding heartbeat). Either way, doctors can see changes on an electrocardiogram (ECG) that warn them about TdP.
If you have concerns about TdP or being in the hospital to start dofetilide, tell your doctor. They may recommend a different treatment.
To learn more, talk with your doctor or pharmacist.
Other warnings
Dofetilide could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether dofetilide is a safe option for you.
Ask your doctor about specific warnings for dofetilide, and be sure to tell your doctor about your:
- current health, including any allergies to medications
- past health conditions or surgeries
Allergic reaction
Dofetilide can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.
If you’ve had an allergic reaction to dofetilide or any of its ingredients, your doctor will likely not prescribe dofetilide. They can tell you about medications that are safer options for you.
A mild allergic reaction may cause the following symptoms:
A severe allergic reaction may cause the following symptoms:
- swelling under your skin, usually in your hands, feet, eyelids, or lips
- swelling of your mouth, throat, or tongue, which can cause breathing problems
If you have an allergic reaction to dofetilide, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.
Overdose of dofetilide
If you take dofetilide by mouth, you should not take more dofetilide than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.
If you think you’ve taken too much dofetilide, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.
Pregnancy or breastfeeding and dofetilide
Information about dofetilide and pregnancy and breastfeeding is described below.
Dofetilide and pregnancy
It’s not known whether dofetilide should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Dofetilide and breastfeeding
Dofetilide should not be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. Your doctor may recommend other ways to feed your child during treatment with dofetilide.
Uses
Uses of dofetilide
The Food and Drug Administration (FDA) approves prescription drugs such as dofetilide for certain conditions. Approved uses for dofetilide are described below.
Use for heart rhythm problems
Doctors may prescribe dofetilide oral capsule for treating heart rhythm problems called atrial fibrillation (AFib) and atrial flutter. It’s used for this purpose in adults. It’s usually prescribed as a long-term treatment.
With AFib and atrial flutter, the heart’s atria beat too fast and unevenly. (The atria are the upper chambers of the heart). Having AFib or atrial flutter increases your risk of stroke, heart failure, and heart valve disease. Symptoms of AFib or atrial flutter may include:
- chest pain
- dizziness or lightheadedness
- fatigue
- feeling a fast or pounding heartbeat
- shortness of breath
Doctors may not prescribe dofetilide oral capsule in certain situations, such as for people who:
- have a heart problem called long QT interval syndrome
- have severe kidney problems
- take certain medications
FAQs
Common questions about dofetilide
Below you’ll find answers to a few commonly asked questions about dofetilide.
What brand names are available for dofetilide?
Dofetilide is available as the brand-name drug, Tikosyn. Dofetilide oral capsule is the generic version of this product.
A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.
You can learn more about this by talking with your doctor or pharmacist.
Does dofetilide cause long-term side effects?
No, long-term side effects aren’t expected with dofetilide. In studies, specific side effects weren’t seen in people who had taken the drug for a long time. Long lasting side effects after treatment ended also weren’t reported. But some serious side effects, such as stroke and heart attack, can have long lasting effects.
Talk with your doctor if you have questions about possible long-term side effects of dofetilide.
How does dofetilide work? And how long does it take to start working?
Dofetilide’s mechanism of action (the way that it works) is to slow electrical activity in the heart. It increases the amount of time that heart cells are at rest. This helps the heart stay at a regular rate and rhythm.
Dofetilide will start working within 2–3 hours of taking the first dose. But it can take up to 3 days to reach steady levels in your body. You’ll be in the hospital for the first few days of treatment, so your doctor can monitor you closely.
If you’d like to know more about this, talk with your doctor or pharmacist.
Ask your doctor
What to ask your doctor
Let your doctor know if you have questions about dofetilide or would like more details about it.
Here’s a list of some possible questions you may want to ask your doctor:
- What is the most important information I should know about dofetilide?
- How should I take dofetilide?
- What should I do if I miss a dose of dofetilide?
- Am I at higher risk of side effects than other people?
- What are my options if dofetilide doesn’t work or I can’t take it?
Resources
Resources
- Dofetilide capsules. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/0e60aa4b-72c2-4ef4-ab01-c9cf94240ff1/spl-doc
- Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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