What is Rasilez HCT?
Rasilez HCT is a medicine containing the active substances aliskiren and hydrochlorothiazide. It is available as oval tablets (white: 150 mg aliskiren and 12.5 mg hydrochlorothiazide; yellowish: 150 mg aliskiren and 25 mg hydrochlorothiazide; light purple: 300 mg aliskiren and 12.5 mg hydrochlorothiazide; yellow clear: 300 mg of aliskiren and 25 mg of hydrochlorothiazide).
What is Rasilez HCT used for?
Rasilez HCT is indicated for the treatment of essential hypertension (high blood pressure) in adults. The term "essential" indicates that the cause of hypertension is unknown.
Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone. It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active ingredients.
The medicine can only be obtained with a prescription.
How is Rasilez HCT used?
The recommended dose of Rasilez HCT is one tablet a day. The medicine should be taken with a light meal, preferably at the same time each day, avoiding taking it with grapefruit juice. The dosage depends on the doses of aliskiren and / or hydrochlorothiazide previously taken by the patient.
In patients who previously took only aliskiren or hydrochlorothiazide it may be necessary to take the two substances in separate tablets and adjust the doses before switching to Rasilez HCT. After taking Rasilez HCT for two to four weeks, the dose may be increased in patients whose blood pressure remains uncontrolled.
In patients who are adequately controlled with the two active ingredients, the dose of Rasilez HCT must contain the same doses of aliskiren and hydrochlorothiazide that the patient previously took.
Rasilez HCT should be used with caution in patients suffering from liver disorders and should not be used in patients suffering from severe liver or kidney problems.
How does Rasilez HCT work?
Rasilez HCT contains two active substances, aliskiren and hydrochlorothiazide.
Aliskiren is a renin inhibitor. It inhibits the activity of a human enzyme called renin, which participates in the production of a substance in the body called angiotensin I. Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (substance that causes the
narrowing of blood vessels). When angiotensin I production is blocked, angiotensin I and angiotensin II levels decrease. This causes a vasodilation (dilation of blood vessels) and therefore a drop in blood pressure.
Hydrochlorothiazide is a diuretic, another type of antihypertensive treatment. It works by increasing urinary output, reducing the amount of fluid in the blood and thus reducing arterial pressure.
The combination of the two active ingredients produces a further effect which is to reduce the blood pressure to a greater extent than the two medicines taken separately. By reducing blood pressure, the risk caused by hypertension, such as stroke, decreases.
What studies have been performed on Rasilez HCT?
Aliskiren alone has been authorized since August 2007 in the European Union (EU) as Rasilez, Enviage, Sprimeo, Tekturna and Riprazo. The company presented the information used in the evaluation of aliskiren and taken from the published literature supporting the application for Rasilez HCT as well as information from additional studies.
In general, the company presented the results of nine main studies involving around 9, 000 patients with essential hypertension. Most of the studies involved patients with mild to moderate hypertension and a study with patients with severe hypertension. The studies compared the combination of aliskiren and hydrochlorothiazide with a placebo (a dummy treatment), with aliskiren or hydrochlorothiazide taken separately, or with other antihypertensive medicinal products (valsartan, irbesartan, lisinopril or amlodipine). The duration of the studies ranged from eight weeks to one year and the main measure of effectiveness was the change in blood pressure during the resting phase of the heartbeat (diastolic pressure) or during the contraction phase of the cardiac cavities (systolic pressure).
Three further studies were carried out to show that the active ingredients were absorbed by the body in the same way they were absorbed when taken in separate tablets and in the form of Rasilez HCT.
What benefit has Rasilez HCT shown during the studies?
Rasilez HCT was more effective than placebo in reducing blood pressure. In patients in whom blood pressure was not adequately controlled with aliskiren or hydrochlorothiazide taken as monotherapy, the transition to their combination resulted in greater declines in blood pressure compared to the intake of an active ingredient alone.
What is the risk associated with Rasilez HCT?
The most common side effect with Rasilez HCT (seen in between 1 and 10 patients out of 100) is diarrhea. For the full list of all side effects reported with Rasilez HCT, see the Package Leaflet.
Rasilez HCT should not be used in people who may be hypersensitive (allergic) to aliskiren, hydrochlorothiazide or any of the other ingredients or sulfonamides. It must not be used in patients with angioedema (subcutaneous swelling) following the use of aliskiren, who have severe kidney or liver problems, or whose potassium levels are too low or those of calcium that are too high. It must not be taken together with ciclosporin (a medicine that reduces the activity of the immune system) or other medicines that slow down the metabolism of aliskiren in the body, such as quinidine (used to correct an irregular heartbeat) or verapamil (used to treat problems cardiac). It must not be used in women who have been pregnant for more than three months or who are breastfeeding. It is not recommended in the first three months of pregnancy.
Why has Rasilez HCT been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rasilez HCT's benefits are greater than its risks for the treatment of essential hypertension in adults whose blood pressure is not sufficiently controlled with aliskiren or hydrochlorothiazide taken on its own, or adequately controlled with aliskiren and hydrochlorothiazide taken together, in the same doses present in the combination. The Committee therefore recommended that Rasilez HCT be given marketing authorization.
More information on Rasilez HCT
On 16 January 2009, the European Commission granted a marketing authorization valid throughout the European Union for Rasilez HCT to Novartis Europharm Limited.
For the full EPAR of Rasilez HCT, click here.
Last update of this summary: 12-2008
