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Tikosyn, Dofetilide (generic): Frequently Asked Questions

What doses of TIKOSYN are available?

TIKOSYN is available in 3 dosages: 500 mcg, 250 mcg, and 125 mcg, and is available in bottles of 40 units in hospital pharmacies and 60 capsules in retail pharmacies.

What is TIKOSYN indicated for?

TIKOSYN is indicated for the maintenance of, and conversion to, normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) of greater than 1 week duration in highly symptomatic patients with persistent AF/AFl.

What are contraindications for use of TIKOSYN?

TIKOSYN is contraindicated with verapamil, hydrochlorothiazide (alone or in combination, such as with triamterene), and cation transport inhibitors such as cimetidine, ketoconazole, trimethoprim (alone or in combination with sulfamethoxazole), prochlorperazine, and megestrol. TIKOSYN is also contraindicated in patients with congenital or acquired QT syndromes, severe renal impairment, or known hypersensitivity to TIKOSYN. Click here to see a list of contraindications for use of TIKOSYN.

What hemodynamic effects occur with Tikosyn?

Tikosyn has no negative inotropic effects and no effect on cardiac output, cardiac index, stroke volume index or systemic vascular resistance. In the overall clinical program for Tikosyn there was no effect on blood pressure and heart rate was decreased by 4 to 6 beats per minute.

What electrophysiologic effects should be monitored with Tikosyn?

Tikosyn causes an increase in QT interval on ECG as a result of it’s effect in prolonging both the effective and functional refractory periods of the action potential. Tikosyn does not influence cardiac conduction velocity and sinus node function which is consistent with a lack of effect on the PR interval and QRS width in patients with pre-existing heart block and/or sick sinus syndrome. ...
Tikosyn causes an increase in QT interval on ECG as a result of it's effect in prolonging both the effective and functional refractory periods of the action potential. Tikosyn does not influence cardiac conduction velocity and sinus node function which is consistent with a lack of effect on the PR interval and QRS width in patients with pre-existing heart block and/or sick sinus syndrome. ...

How does Tikosyn affect mortality in patients with heart failure?

Survival data from large, double-blind trials (DIAMOND-CHF and DIAMOND-MI) showed that 1-year mortality rates were 36% (541 of 1511 patients) with Tikosyn and 37% (560 of 1517 patients) with placebo. In an analysis of 506 high-risk patients with significant heart failure (LVEF<35%) and atrial fibrillation/flutter at baseline the 1-year mortality on Tikosyn was 31% versus 32% on placebo.

Can TIKOSYN be ordered from my wholesaler?

TIKOSYN is not stocked by your wholesaler, but must be ordered through your wholesaler. See ordering steps below: Order TIKOSYN through your wholesaler TIKOSYN orders faxed by your wholesaler are processed during normal Pfizer Customer Service business hours—Monday through Friday 7:00AM to 6:00PM Central Time Pfizer will verify pharmacy enrollment and drop-ship TIKOSYN to pharmacy For further information on how to order TIKOSYN, please call a Customer Service Representative at 1-877-TIKOSYN (845-6796)

Can I prescribe Tikosyn for patients with renal or hepatic dysfunction?

Tikosyn is CONTRAINDICATED for patients with a creatinine clearance <20 ml/min. Dose reduction is required for patients with a CLCr of 20-60 mL/min. (See Tikosyn (dofetilide) Dosing Algorithm). No additional dose reduction is required for patients with mild to moderate hepatic impairment. Patients with severe hepatic dysfunction have not been studied and caution should be used in prescribing Tikosyn for these patients.

What steps do I need to follow to dispense TIKOSYN?

The first step is enrollment. Access the retail pharmacy link on this website; complete and submit the T.I.P.S.™ Program Enrollment Form. Additionally, for your convenience, the T.I.P.S.™ Program Kit can also be ordered through this website. or Contact our Customer Service Representative at 1-877-TIKOSYN (845-6796) and request a T.I.P.S.™ Enrollment and Program Kit. ...
The first step is enrollment. Access the retail pharmacy link on this website; complete and submit the T.I.P.S.T Program Enrollment Form. Additionally, for your convenience, the T.I.P.S.T Program Kit can also be ordered through this website. or Contact our Customer Service Representative at 1-877-TIKOSYN (845-6796) and request a T.I.P.S.T Enrollment and Program Kit. ...

Can Tikosyn maintain NSR in patients requiring electrical cardioversion?

In 2 well-controlled clinical trials, Tikosyn was significantly (P≤0.001) more effective than placebo at maintaining patients in NSR for 1 year. In both studies, patients who did not convert to NSR pharmacologically were electrically cardioverted. There was no difference in maintenance of NSR among the patients cardioverted electrically versus those converted pharmacologically

How does Tikosyn act to convert atrial fibrillation or flutter to normal sinus rhythm?

Tikosyn demonstrates Vaughan Williams class III antiarrythmic activity. The mechanism of action is blockade of the cardiac ion channel carrying the rapid component of the delayed rectifier potassium current, IKr. Tikosyn is both highly potent and highly specific with no relevant blockade of other repolarizing potassium currents. Tikosyn increases the monophasic action potential duration in a concentration-dependent manner because of delayed repolarization. ...

How can I obtain TIKOSYN patient-education or physician-related materials?

To obtain patient-education or physician-related materials, please call 1-877-TIKOSYN (845-6796) or visit our website at www.Tikosyn.com for immediate access to Tikosyn materials.

How can I check if a prescriber has been confirmed in the TIKOSYN program?

Before dispensing a TIKOSYN prescription, pharmacists must confirm that the prescriber is a Healthcare professional who has participated in the TIKOSYN Education Distribution Program and is listed in the TIKOSYN confirmed database. To verify that a prescriber is a participant in the program, pharmacists will need to access the program database by phone at 1-800-788-7353 or online at www.tikosynlist.com and enter their pharmacy DEA number. ...

How can I find out which retail pharmacies are enrolled in the program and can stock and dispense TIKOSYN?

Patients and physicians can call 1-877-TIKOSYN and speak to a Customer Service Representative (CSR) to find out if a pharmacy is enrolled in T.I.P.S.™ The CSR can provide this information when given the name, address, or ZIP code for the pharmacy. If a pharmacy is not enrolled in the T.I.P.S.™ program, the pharmacist can call 1-877-TIKOSYN to learn how to enroll and order TIKOSYN. To find out if a pharmacy stocks TIKOSYN, the patient or physician must call the pharmacy directly. ...
Patients and physicians can call 1-877-TIKOSYN and speak to a Customer Service Representative (CSR) to find out if a pharmacy is enrolled in T.I.P.S.T The CSR can provide this information when given the name, address, or ZIP code for the pharmacy. If a pharmacy is not enrolled in the T.I.P.S.T program, the pharmacist can call 1-877-TIKOSYN to learn how to enroll and order TIKOSYN. To find out if a pharmacy stocks TIKOSYN, the patient or physician must call the pharmacy directly. ...

Does allowing retail pharmacies to provide/dispense TIKOSYN eliminate the need to hospitalize the patient upon initiation?

According to the TIKOSYN boxed warning, to minimize the risk of induced arrhythmia, TIKOSYN should be reserved for patients who are highly symptomatic, and patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a hospital or other facility that can calculate creatinine clearance, and provide continuous electrocardiographic monitoring and cardiac resuscitation. ...

Do physicians still need to participate in the TIKOSYN program before they can prescribe the drug?

Yes. To comply with the TIKOSYN boxed warning, only confirmed participants in the TIKOSYN program will be able to prescribe TIKOSYN. The retail pharmacist will be responsible for checking the TIKOSYN Confirmed Prescriber Database.

Will the current mail-order program still be available for my TIKOSYN patients who prefer to receive their drug from PharmaCare Specialty Pharmacy?

Yes. The PharmaCare Specialty Pharmacy mail-order program will continue to be available to patients who prefer to receive their medication through PharmaCare. Upon patient discharge, PharmaCare requires the pharmacy enrollment form be completed and faxed along with the prescription, to PharmaCare Specialty Pharmacy.
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