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Novartis receives FDA approval of Tekamlo™, a single-pill combination of aliskiren and amlodipine to treat high blood pressure
Date:8/27/2010

receptor antagonists. Discontinue Tekamlo immediately in patients who develop angioedema and do not readminister.

Excessive hypotension was rarely seen (0.2%) in patients with uncomplicated hypertension treated with Tekamlo in controlled trials. Volume- and/or salt-depletion should be corrected prior to administration of Tekamlo or symptomatic hypotension may occur.

Rarely, initiation or change to the dose of a calcium channel blocker has resulted in the increased frequency, duration, or severity of angina or acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease.

Clinical trials with Tekamlo in hypertension excluded patients with severe renal impairment. Clinical trials of aliskiren in hypertension excluded patients with severe renal dysfunction (GFR <30mL/min).  Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances.

Caution should be exercised when administering Tekamlo to patients with severe renal impairment, as amlodipine is extensively metabolized by the liver and the plasma elimination half-life is 56 hours in patients with impaired hepatic function.  

Titrate Tekamlo slowly in patients with heart failure.

No data are available on the use of Tekamlo or aliskiren in patients with unilateral or bilateral renal artery stenosis. However, in studies of ACEIs in hypertensive patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported.

Exercise caution when co-administering Tekamlo with ACEIs, potassium-sparing diuretics, potassium supplements, or other potassium containing salt substitutes.

Concomitant use of Tekamlo with cyclosporine is not recommended.

The most common adverse event in a placebo-controlled trial that occurred in at least 2% of patients treated with Tekamlo and at a higher incidence than placebo was peripheral ed
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SOURCE Novartis Pharmaceuticals Corporation
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