Novartis announces Aliskiren will continue to be available to appropriate patients, as FDA interim assessment is concluded; product information updated - Seite 2
About Aliskiren-based products in the US
The US Prescribing Information has been updated for Tekturna, Tekturna HCT(®)
(aliskiren and hydrochlorothiazide), Tekamlo(TM) (aliskiren and amlodipine) and
Amturnide(TM) (aliskiren, amlodipine and hydrochlorothiazide).
In view of the importance of controlling high blood pressure and to enable
physicians to transition patients to alternate therapies, Novartis will make
Valturna available in the US until July 20, 2012. Novartis advises patients in
the US to seek guidance from their prescribing healthcare provider at their next
(non-urgent) visit, prior to July 20, 2012, to determine appropriate alternate
therapy. Novartis will communicate to US physicians informing them of the above
actions.
About ALTITUDE
ALTITUDE was a multinational study in 8,606 patients from 36 countries
evaluating the potential benefits of aliskiren to reduce the risk of
cardiovascular and renal events in this patient population.
ALTITUDE was the first randomized, double-blind, placebo-controlled study to
investigate aliskiren for more than one year in a specific population of
patients with type 2 diabetes and renal impairment. These patients are known to
be at high risk of cardiovascular and renal events. In the study, aliskiren was
given in addition to optimal cardiovascular treatment including an angiotensin
converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
About Aliskiren
Aliskiren was approved in the US and EU in 2007 under the brand names Tekturna
and Rasilez, respectively, for the treatment of hypertension either as
monotherapy or in combination with other medications. It is available in 63
countries. These products remain available for appropriate patients. For
additional information, please visit http://www.novartis.com/newsroom/product-
related-info-center/resilez-tekturna.shtml.
US Important Safety Information
TEKTURNA, TEKTURNA HCT, TEKAMLO, and AMTURNIDE are indicated for the treatment
of hypertension in adults, to lower blood pressure. Lowering blood pressure
reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes
and myocardial infarctions. Control of high blood pressure should be part of
comprehensive cardiovascular risk management, including, as appropriate, lipid
control, diabetes management, antithrombotic therapy, smoking cessation,
exercise, and limited sodium intake. Many patients will require more than one
drug to achieve blood pressure goals.
Lesen Sie auch
AMTURNIDE is not indicated for initial therapy of hypertension
Use TEKTURNA HCT or TEKAMLO as initial therapy in patients who are likely to
need multiple drugs to achieve their blood pressure goals. Switch a patient