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  Triple-double from RxLink®


From: Reliant Pharmaceuticals                                                 03/27/04        

Important News For Pharmacies---From Reliant Pharmaceuticals

Reliant Pharmaceuticals is now the sole owner and marketer of the RYTHMOL(propafenone HCI) brand family of products in the United States

Reliant Pharmaceuticals is also pleased to announce the availability of RYTHMOL SR (propafenone HCI) extended release capsules BID (every 12 hours)--a new, more convenient formulation of RYTHMOL (propafenone HCI) for patients with atrial fibrillation(AFib).  RYTHMOL SR is indicated to prolong the time of recurrence of symptomatic AFib in patients without structural heart disease.

        In clinical trials, RYTHOMOL SR significantly delayed the time to first recurrence of symptomatic AFib, with increased efficacy  at each dose.

         Three convenient BID (every 12 hours) dosing options are available:225, 325, or 425 mg capsules.  Physicians must titrate for individual patient needs and tolerance.  Treatment initiation with new RYTHMOL SR does not require hospitalization and may result in cost savings to the patient.  No loading dose is required, and there is no need for ongoing hepatic toxicity monitoring in patients with normal hepatic function.

          Therapy should be initiated with RYTHMOL SR 225 MG bid (every 12 hours).  If addition therapeutic effect is needed, dosage may be increased at 5-day intervals9minimum).  The switch from RYTHMOL TID to BID dosing does not follow a 1 mg:1 mg conversion rule.  For example, patients taking 150 mg propafenone TID (450 mg/day) would be switched to RYTHMOL SR 325mg BID (650 mg/day).  Pleade see Pharmacokinetics and Metabolism section of full Prescribing Information.

To ensure maximum knowledge of RYTHMOL SR, Reliant Pharmaceuticals is currently rolling out multifaceted programs, including:

  • Nationwide detailing by a dedicated cardiovascular specialty sales force

  • Professional education programs designed to reinforce product information

  • A comprehensive promotional campaign

Because we expect this marketing effort to create a surge in demand for RYTHMOL SR, we are encouraging pharmacists to contact their wholesalers in order to ensure that ample supplies are available for prescription fulfillment.  To assist you in ordering RYTHMOL SR, we have enclosed a fact sheet with product/packaging specifications and ordering/pricing information.

           Reliant Pharmaceuticals is committed to maintaining a position partnership with our customers and we promise to prvide you with the best possible service and support.  If you would like additional information about RYTHMOL SR and/or our company, please feel free to contact our Customer Service Department at 1-800-475-2140.


Andrew H. Isaacs 

RYTHMOL Family Brand Manager        Reliant Pharmaceuticals                                                                                                                                                      

Please see Boxed Warning on reverse side of this letter and enclosed Prescribing Information



RYTHMOL SR  (propafenone HCI) extented release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.

The use of RYTHMOL SR in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. RYTHMOL SR  should not be used to control ventricular rate during atrial fibrillation.

The effect of RYTHMOL SR on mortality has not been determined ( see black box WARNINGS).

Important Safety Information                                                                                                                                              WARNINGS                                                                                                                                                                       Mortality:                                                                                                                                                                         In the National Heart, Lung and Blood Institue's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, umlti-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more that six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725).  The average duration of treatment with encainide or flecainide in this study was ten months.

The applicability of the CAST results to other populations (e.g. those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present it is prudent to consider any 1C antiarrhythmic to have a significant rist in patients with structural heart disease.  Given the lack of any evidence that these drugs improve survival, antiarrghthmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experienceing unpleasant, but not life-threatening, symptoms or signs.

The most commonly reported adverse events in the trial included dizziness, chest pain, palpitations, taste disturbance, dyspnea, nausea, constipation, anxiety, fatigue, upper respiratior tract infection, influenza, first degree heart block and vomiting.

References: 1. RYTHMOL SR Prescribing Information, Reliant Pharmaceuticals. 2. Pritchet ED, Page RL, Carlson M, Undesser K. Fava G, for the Tythmol Atrial Fibrillation Trial (RAFT) Investigators, Efficacy and safety of sustained-rease propafenone SR) for patients with atrial fibrillation. Am J. Carfiol, 2009-92-946.3. Meinerftz T. Lip GYH, Lombardi Fet al. on behalf of the ERAFT Investigators Efficacy and safety of propafenone sustained release in the prophylaxis of sympthomatic paroxysmal atrial fibrillation (The European Rythmol/Rytmonrm Atrial Fibrillation Trial [ERAFT] Study) Am J Cardiol 2002;90:1300-1306.

Reliant Pharmaceuticals january 2004   RYTH-2001

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To: RxLink®

From: Ortho Biotech

August 13, 2004

Dear Health Care Professional:

Ortho Biotech Products, LP ("Ortho Biotech"), wishes to advise you of important changes to the safety information and dosing sections of the product labeling for PROCRIT epoetin alfa. To ensure consistency with labeling for other products in this class, changes to hemoglobin rate of rise and target have been made.

Hemoglobin rise

The newly revised  prescribing information for PROCRIT in its cancer chemotherapy indication recommends dosing interruption and modification if the rate of rise of hemoglobin exceeds 1 gram per deciliter over a 2-week period. The goal of treatment (hemoglobin target level) should be individually determined for each patient, and this target may range form 10 up to 12 grams per deciliter. Importantly, the new prescribing information recommends that the target hemoglobin in patients with cancer should not exceed 12 grams per deciliter in men and women. The dose should be withheld if the hemoglobin is 13 grams per deciliter, or above. This guideline applies whether patients are treated with PROCRIT three times weekly or with the newly approved once weekly dosing regimen (see below).

The new recommendations result from recent investigational studies, some with erythropoietin products other than PROCRIT, and conducted outside the US, where patients with cancer were treated to high hemoglobin target levels, beyond the correction of anemia. These studies permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events was reported in these studies. Additional details of these studies are included in the following sections of the revised Prescribing Information: See WARNINGS-Thrombotic Events and Mortality and PRECAUTIONS-Tumor Growth Factor Potential.

Since all erythropoietin products share similarities in mechanism of action, Ortho Biotech deems this information to be relevant for prescribers and patients to help ensure the safe and effective use of PROCRIT.

Dosage and Administration:

Previously, the only dosing regimen specified in PROCRIT labeling for the cancer chemotherapy indication was 150 IU per kilogram SC TIW. Recently, another dosing regimen, 40,000 IU SC weekly, has been approved for use in this patient population. The revised product labeling includes the following guidance regarding once weekly dosing of PROCRIT:

-The starting dose is 40,000 Units SC weekly. If after 4 weeks of therapy, the hemoglobin has not increased by > 1 g/dL, in the absence of RBC transfusion, the PROCRIT dose should be increased to 60,000 Units weekly.

-If patients have not responded satisfactorily to a PROCRIT dose of 60,000 Units weekly after 4 weeks, it is unlikely that they will respond to higher doses of PROCRIT.

Ortho Biotech is committed to providing you with the most current product information for PROCRIT. You can report adverse events to Ortho Biotech at Medical Information at 1-800-325-7504, Prompt #2. Alternately, this information may be reported to FDA's MedWatch reporting system by phone (1-800-FDA-1088), facsimile (1-800-FDA-0178), the MedWatch website at www.fda.gov/medwatch, or mailed to MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787. Both healthcare professionals and consumers should use Form 3500 (available at the MedWatch website) for reporting adverse events.

A copy of the revised prescribing information for PROCRIT is enclosed. Should you have any questions or require further information regarding the use of PROCRIT, please contact the Ortho Biotech Medical Information at 1-800-325-7504, prompt #2.


Marc Kamin, M.D.

Vice President, Ortho Biotech Clinical Affairs, LLC.

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