Tikosyn

Dofetilide comes as a capsule to take by mouth. It is usually taken twice a day, but may be taken once a day in people with certain conditions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dofetilide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dofetilide controls abnormal heart rhythms but does not cure them. Continue to take dofetilide even if you feel well. Do not stop taking dofetilide without talking to your doctor.

Before taking dofetilide,

• tell your doctor and pharmacist if you are allergic to dofetilide, any other medications, or any of the ingredients in dofetilide capsules. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
• tell your doctor if you are taking cimetidine (Tagamet), dolutegravir (Tivicay), hydrochlorothiazide (Microzide, Oretic), hydrochlorothiazide and triamterene (Dyazide, Maxzide), ketoconazole (Nizoral), megestrol (Megace), prochlorperazine (Compro, Procomp), trimethoprim (Primsol), trimethoprim and sulfamethoxazole (Bactrim, Septra, Sulfatrim), and verapamil (Calan, Covera, Verelan). Your doctor will probably tell you not to take dofetilide if you are taking one or more of these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiloride (Midamor); antibiotics such as erythromycin (E.E.S., E-Mycin) and norfloxacin (Noroxin); certain antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); bepridil (Vascor); cannabinoids such as dronabinol (Marinol), nabilone (Cesamet) or marijuana (cannabis); digoxin (Lanoxin); diltiazem (Cardizem, Cartia XT, Dilacor XR, Taxtia XT, Tiazac); diuretics ('water pills'); HIV protease inhibitors including atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase) and tipranavir (Aptivus); medications for asthma such as zafirlukast (Accolate); medications for depression, mental illness, or nausea; medications for irregular heart beats such as amiodarone (Cordarone, Pacerone); metformin (Fortamet, Glucophage, Glumetza, Riomet); nefazodone;or quinine (Qualquin).
• tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), or kidney disease.
• tell your doctor if you have excessive diarrhea, sweating, vomiting, loss of appetite, or decreased thirst or a low level of potassium in your blood, and if you have or have ever had have heart or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dofetilide, call your doctor.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

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.

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Tikosyn can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death.

To establish the right dose of Tikosyn, treatment with Tikosyn must be started in a hospital where your heart rate and kidney function will be checked for the first 3 days of treatment. It is important that when you go home, you take the exact dose of Tikosyn that your doctor prescribed for you.

While you take Tikosyn, always watch for signs of abnormal heartbeat.

Call your doctor and go to the hospital right away if you:

• feel faint
• become dizzy, or
• have a fast heartbeat

Do not take Tikosyn if you:

• have an irregular heartbeat called long QT syndrome
• have kidney problems or are on kidney dialysis
• are allergic to Tikosyn or any other ingredients in this medication
• take any of these medicines:
  • cimetidine (Tagamet)
  • verapamil (Calan, Verelan)
  • ketoconazole (Nizora, Xolegel, Extina)
  • trimethoprim alone (Proloprim, Trimpex) or the combination of trimethoprim and sulfamethoxazole (Bactrim, Septra)
  • prochlorperazine (Compazine, Compo)
  • megestrol (Megace)
  • hydrochlorothiazide alone or in combination with other medicines (Exidrix, Ezide, Hydrodiuril, Hydro-Par, Microzide, or Oretic)

Take Tikosyn exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The usual recommended dose range of  Tikosyn (dofetilide) is 125 to 500 mcg once or twice daily. This dose will be based on your kidney and heart rhythm activity.

To minimize the risk of induced arrhythmia, patients initiated or re-initiated on Tikosyn should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. Tikosyn is available only to hospitals and prescribers who have received appropriate Tikosyn dosing and treatment initiation education.

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.

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

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

Storage

Oral

15–30°C in tight, well closed containers.1 Protect from moisture and humidity.1

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 dofetilide 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 dofetilide in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving dofetilide.

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.

• Amifampridine
• Amisulpride
• Bepridil
• Cimetidine
• Cisapride
• Dolutegravir
• Dronedarone
• Fingolimod
• Fluconazole
• Hydrochlorothiazide
• Itraconazole
• Ketoconazole
• Levomethadyl
• Megestrol
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Prochlorperazine
• Saquinavir
• Sparfloxacin
• Sulfamethoxazole
• Terfenadine
• Thioridazine
• Trimethoprim
• Verapamil
• Vernakalant
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Alfuzosin
• Amiloride
• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Azosemide
• Bedaquiline
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Bretylium
• Bumetanide
• Buserelin
• Buthiazide
• Chloral Hydrate
• Chloroquine
• Chlorothiazide
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clopamide
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclothiazide
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Diazoxide
• Dibenzepin
• Digoxin
• Dirithromycin
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Efavirenz
• Enflurane
• Erythromycin
• Escitalopram
• Ethacrynic Acid
• Etozolin
• Fenquizone
• Flecainide
• Fluoxetine
• Foscarnet
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydroflumethiazide
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Isoflurane
• Isradipine
• Ivabradine
• Josamycin
• Lamotrigine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lidoflazine
• Lopinavir
• Lorcainide
• Lumefantrine
• Mefloquine
• Metformin
• Methadone
• Methyclothiazide
• Metolazone
• Metronidazole
• Mifepristone
• Moricizine
• Moxifloxacin
• Nafarelin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Piretanide
• Pitolisant
• Polythiazide
• Prilocaine
• Probucol
• Procainamide
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinethazone
• Quinidine
• Ranolazine
• Ribociclib
• Risperidone
• Roxithromycin
• Salmeterol
• Sematilide
• Sertindole
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Toremifene
• Torsemide
• Trazodone
• Triamterene
• Trichlormethiazide
• Trifluoperazine
• Trimipramine
• Triptorelin
• Troleandomycin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Vinflunine
• Voriconazole
• Xipamide
• Zolmitriptan
• Zotepine
• Zuclopenthixol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Electrolyte imbalance (eg, low magnesium or potassium levels in the blood) or
• Heart disease or
• Heart rhythm problems—Use with caution. May make these conditions worse.

• Heart rhythm problem (eg, congenital long QT syndrome) or
• Kidney disease, severe or
• Patients receiving dialysis treatment—Should not be used in patients with these conditions.

• Kidney disease—Higher blood levels may occur, which may increase the chance of side effects. Your doctor may need to change your dose.

• Liver disease, severe—Use with caution. This medicine has not been studied in patients with this condition.

ALWAYS DISPENSE WITH MEDICATION GUIDE

Pfizer

NDC 0069-5810-60
Rx only

Tikosyn®

(dofetilide)

250 mcg (0.25 mg)

60 Capsules

FOR INSTITUTION USE

Tikosyn®

(dofetilide) Capsule

500mcg (0.5mg)

PFIZER LABS
DIV. OF PFIZER INC, NY, NY 10017

EXP & LOT AREA