Products from Noden Pharma

Noden Pharma—Current Products

Hypertension

Hypertension is a common chronic condition with serious long-term cardiovascular implications. It is associated with a number of serious risk factors including increased risk of cardiovascular disease, such as congestive heart failure, stroke and myocardial infarction (heart attack) as well as increased risk of chronic renal insufficiency and end stage renal disease.1,2 Hypertension is largely an asymptomatic disease, with unrecognizable signs or symptoms by the patient. As a result, patients may often behave with poor medication adherence and lack of persistence with treatment.3

In the United States, hypertension affects nearly 1/2 of adults.4 While evidence-based guidelines do not provide specific direction governing the order of the use of medicines for initial hypertension treatment, the recommendation for choice of initial treatment is with either a diuretic, a calcium channel blocker (CCB), an angiotensin-converting-enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB). From a cost perspective, many of these classes of drugs available are sold as relatively inexpensive generic versions. It is estimated that nearly one half (46%) of US adults with hypertension are not controlled.5 Subsequently, many patients will require treatment with more than one antihypertensive drug to achieve blood pressure control.2 Drug-related side effects may limit adherence to antihypertensive therapies and are an important contributor to the lack of BP control in patients with hypertension.6,7

Tekturna® and Tekturna HCT®

Tekturna (aliskiren) is approved for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure.8 It is the only approved drug for hypertension that is a direct renin inhibitor. Renin is an enzyme in certain tissues and the bloodstream that can start a process which results in the narrowing of blood vessels. Tekturna inhibits renin which helps blood vessels relax, thus allowing blood to flow more freely and lowering blood pressure.8

Tekturna HCT (aliskiren and hydrochlorothiazide) is approved for the treatment of hypertension in adult patients who are not adequately controlled by monotherapy or who are likely to need multiple drugs in their initial treatment to achieve their goals of lower blood ressure.9 Tekturna HCT contains two approved medicines – aliskiren, the direct renin inhibitor that is the active ingredient of Tekturna, and hydrochlorothiazide, a diuretic. The hydrochlorothiazide assists in reducing blood pressure by reducing sodium and water in the body thereby reducing blood volume and blood pressure.9

The prescribing information for TEKTURNA and TEKTURNA HCT includes a boxed warning for fetal toxicity, a contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes, and a warning to avoid the use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment.8,9

Rasilez® and Rasilez HCT®

Rasilez and Rasilez HCT are the ex-US brand names of Tekturna and Tekturna HCT, respectively.

  1. References
    1. Emelia J. Benjamin et al. Heart Disease and Stroke Statistics—2018 Update: A Report From the American Heart Association, Circulation (2018). DOI: 10.1161/CIR.0000000000000558.
    2. Whelton PK, Carey RM, Aronow WS et al. 2017 AC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guidelines for the prevention, detection, evaluation, and management of high blood pressure in adults. J Amer Coll Cardiol. 2017; DOI: 10.1016/j.jacc.2017.11.006. Accessed October 2018.
    3. Burnier, M. Am J Hypertens. 2006 Nov;19(11):1190-6. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. DOI:  10.1016/j.amjhyper.2006.04.006. Accessed October 2018.
    4. https://medicalxpress.com/news/2018-02-million-americans-high-blood-pressure.html . Accessed October 2018.
    5. Merai R, Siegel C, Rakotz M, Basch P, Wright J, Wong B; DHSc., Thorpe P. CDC Grand Rounds: A Public Health Approach to Detect and Control Hypertension. MMWR Morb Mortal Wkly Rep. 2016 Nov 18;65(45):1261-1264.
    6. Neutel J, Smith D. J Clin Hypertens. 2003;5:127-132.
    7. Thomopoulos et al. J Hypertens. 2016; 34:1921-1932.
    8. Tekturna Prescribing Information. Boston, MA: Noden Pharma USA Inc; Nov 2017.
    9. Tekturna HCT Prescribing Information. Boston, MA: Noden Pharma USA Inc; Nov 2016.


Noden Pharma USA Inc.
Boston, MA

©2018 Noden Pharma USA Inc.

10/18

TEK-2018-0113