Multaq
אפריל 2010
צוות רפואי נכבד,
חברת סאנופי אוונטיס שמחה לבשר לך על תחילת שיווק התרופה

Multaq

התרופה מיועדת לטיפול בחולים הסובלים מפירפור/ריפרוף פרוזדורים.
באינדיקציה הבאה:

To reduce the risk of cardiovascular hospitalization and to lower ventricular rate in patients with current or history of paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL) and associated cardiovascular risk factors (i.e. age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > or = 50 mm or left ventricular ejection fraction < 40%), who are in sinus rhythm or who will be cardioverted.

The drug is contraindicated in patients with severe heart failure

Multaq היא תרופה אנטיאריתמית הפועלת על מספר רב של תעלות בתאי שריר הלב המתאימה לכל קטגוריות Vaughan Williams ומסווגת כקבוצה lll בשל פעילותה העיקרית.

Multaq היא התרופה האנטיאריתמית הראשונה והיחידה שנבדקה בחולים עם פירפור/ריפרוף פרוזדורים ונמצאה בטוחה ויעילה בהפחתת תחלואה, תמותה, שבץ מוחי ואישפוזים על רקע קרדיווסקולרי.

Multaq מונעת הישנות הפירפור, מביאה לשיפור התסמינים ולהאטת קצב הלב.

Multaq כל טבליה מכילה דרונדרון 400 מ”ג.

Multaq ניתנת במינון אחיד דרך הפה, שאינו דורש התאמה או ניטור.

Multaq ניתנת במינון של 400 מ”ג פעמיים ביום - טבליה אחת עם ארוחת הבוקר וטבליה שניה עם ארוחת הערב.

Multaq אינה דורשת אישפוז לצורך תחילת טיפול.

Multaq   מאושרת בסל הבריאות לטיפול בחולים עם פירפור פרוזדורים שפיתחו אי סבילות לאמיודרון.

Multaq   משווקת ע”י חברת סאנופי-אוונטיס ומופצת ע”י חברת נובולוג בע”מ.

מידע בטיחות נוסף מצורף לעיונך.

בברכה,
סאנופי-אוונטיס ישראל

Introducing MULTAQ™ (dronedarone) for Atrial Fibrillation

Dear health care provider,
Sanofi-aventis Israel is pleased to inform you that Multaq (dronederone) has been approved by the the Israeli MOH for the treatment of patients with atrial fibrillation or atrial flutter to reduce the risk of cardiovascular hospitalization.
Multaq represents an important therapeutic advancement and treatment option for the
management of atrial fibrillation. This letter highlights important information you should be advised of before prescribing Multaq and actions you can take to help ensure appropriate use of Multaq to maximize patient safety and benefits.

About Multaq
Multaq is a multichannel blocker with properties belonging to all four Vaughan-Williams classes. The safety and efficacy of Multaq has been established in a clinical development program of over 7,000 patients. In clinical studies enrolling patients with atrial fibrillation, Multaq has demonstrated:

  • 24% reduction in the incidence of cardiovascular hospitalization or death from any cause compared with placebo in patients receiving standard therapy
    (ATHENA, n=4628)
  • 25% reduction in risk of first atrial fibrillation /atrial flutter (AF/AFL) recurrence during a 12 month period, and a lower mean ventricular rate at time of first AF/AFL recurrence compared with placebo (ADONIS, EURIDIS)

The most common adverse effects observed more often with Multaq than placebo were gastrointestinal disorders (mostly diarrhea and nausea), skin disorders (mostly rash), and increasing serum creatinine. No excess thyroid, pulmonary, or hepatic disorders were observed with Multaq compared to placebo.

Please consider the following actions when prescribing Multaq for your patients.

  1. Be advised that Multaq is contraindicated in patients with NYHA Class IV or decompensated heart failure.
  2. Be aware of drug drug interactions:
    • Patient should not receive Multaq and potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, cyclosporine, ritonavir) concomitantly due to the
      potential for the latter to significantly increase Multaq levels.
  3. Measure serum creatinine levels after initiating Multaq therapy
    • Multaq has been shown to increase serum creatinine levels through tubular inhibition of creatinine secretion. This effect has rapid onset and is reversible on discontinuation of Multaq. Serum creatnine should be measured approximately 1 week after Multaq initiation.
    • Increased serum creatinine should not be misinterpreted and lead to inappropriate discontinuation of ACE inhibitors and/or angiotensin II receptor blockers.

This letter is not intended to completely describe all information associated with Multaq use. Additional important information about the use of Multaq can be found in the Multaq Prescribing Information.

  • If you have additional questions regarding Multaq, please call our medical information services department at 09-8633700.
  • Health care professionals should report any serious adverse events suspected to be associated with Multaq use to: Sanofi-aventis Israel at 09-8633700.

Together, we can ensure the effective and safe treatment of patients with atrial fibrillation.

Sincerely,
Sanofi-Aventis Israel

Sanofi-Aventis