Members Login
Medical NewsEPG Search
Frequent Searches:
Browse Other Languages
Spanish Drug Data (España)
German Drug Data (Deutsch)
Norwegian Drug Data (Norge)
Netherlands Drug Data (Nederlands)
Swedish Drug Data (Sverige)
German Drug Data (Deutsch)
Norwegian Drug Data (Norge)
Netherlands Drug Data (Nederlands)
Swedish Drug Data (Sverige)
YouTube - Featured Content
Want to submit or suggest content for the epgonline.org YouTube Clinical channel?
Contact us here
epgonline.org is not responsible for content on any 3rd party website
Are you a Doctor or Healthcare Professional? Authorise Viewing
Please register to access disease diagnosis, patient management, physician tools.
By viewing the content of this web page you are both confirming your status as a healthcare professional and agreeing to our terms of use.
Change language
Current language database:
United Kingdom
Medicine information : RASILEZ Tablets
| Drug class description : | Renin inhibitor |
| Generic Name : | Aliskiren |
| Drug description : | Film-coated tablet Rasilez 150 mg film-coated tablets : Light-pink, biconvex, round tablet, imprinted “IL” on one side and “NVR” on the other side. Rasilez 300 mg film-coated tablets : Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side. |
| Presentation : | Rasilez® 150 mg film-coated tablets - Each Rasilez 150 mg film-coated tablet contains 150 mg aliskiren Rasilez® 300 mg film-coated tablets - Each Rasilez 300 mg film-coated tablet contains 300 mg aliskiren |
| Indications : | Treatment of essential hypertension. |
| Adult Dosage : | The recommended dose of Rasilez is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the dose may be increased to 300 mg once daily. The antihypertensive effect is substantially present within two weeks (8590%) after initiating therapy with 150 mg once daily. Rasilez may be used alone or in combination with other antihypertensive agents (See Special Precautions). Rasilez should be taken with a light meal once a day, preferably at the same time each day. Renal impairment No adjustment of the initial dose is required for patients with mild to severe renal impairment (See Special Precautions). Hepatic impairment No adjustment of the initial dose is required for patients with mild to severe hepatic impairment. |
| Child Dosage : | Paediatric patients (below 18 years) - Rasilez is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy. |
| Elderly Dosage : | Elderly patients (over 65 years) - No adjustment of the initial dose is required for elderly patients. |
| Contra Indications : | Hypersensitivity to the active substance or to any of the excipients. Second and third trimesters of pregnancy (See Interactions). |
| Special Precautions : | Patients receiving other medicinal products inhibiting the renin-angiotensin system (RAS), and/or those with reduced kidney function and/or diabetes mellitus are at an increased risk of hyperkalaemia during aliskiren therapy. Aliskiren should be used with caution in patients with heart failure due to limited clinical efficacy and safety data. In the event of severe and persistent diarrhoea, Rasilez therapy should be stopped. Sodium and/or volume depleted patients In patients with marked volume- and/or salt-depletion (e.g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Rasilez. This condition should be corrected prior to administration of Rasilez, or the treatment should start under close medical supervision. Renal impairment In clinical studies Rasilez has not been investigated in hypertensive patients with severe renal impairment (serum creatinine 150 µmol/l or 1.70 mg/dl in women and 177 µmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension. Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Rasilez. Renal artery stenosis No data are available on the use of Rasilez in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney. |
| Interactions : | Rasilez has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes. Compounds that have been investigated in clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate, ramipril and hydrochlorothiazide. No interactions have been identified. Co-administration of aliskiren with either valsartan (28%), metformin (28%), amlodipine (?29%) or cimetidine (?19%) resulted in between 20% and 30% change in Cmax or AUC of Rasilez. When administered with atorvastatin, steady-state Rasilez AUC and Cmax increased by 50%. Co-administration of Rasilez had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics. As a result no dose adjustment for Rasilez or these co-administered medicinal products is necessary. Digoxin bioavailability may be slightly decreased by Rasilez. Preliminary data suggest that irbesartan may decrease Rasilez AUC and Cmax. In experimental animals, it has been shown that P-gp is a major determinant of Rasilez bioavailability. Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the bioavailability of Rasilez. Aliskiren does not inhibit the CYP450 isoenzymes (CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A). Aliskiren does not induce CYP3A4. Aliskiren is metabolised minimally by the cytochrome P450 enzymes, therefore interactions with agents that inhibit, induce or are metabolised by these enzymes are not expected. As a result no dose adjustment for aliskiren is necessary. Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium. If co-medication is considered necessary, caution is advisable. Furosemide When Rasilez was co-administered with furosemide, the AUC and Cmax of furosemide were reduced by 28% and 49% respectively. It is therefore recommended to monitor the effects when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload. Ketoconazole Co-administration of ketoconazole 200 mg twice daily with Rasilez resulted in a 1.8-fold increase in plasma levels of Rasilez (AUC and Cmax). The change in plasma levels in the presence of ketoconazole is expected to be within the range that would be achieved if the dose were doubled; Rasilez doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be safe in well-controlled clinical trials. Preclinical studies indicate that Rasilez and ketoconazole co-administration enhances Rasilez gastrointestinal absorption and decreases biliary excretion. Warfarin The effects of Rasilez on warfarin pharmacokinetics have not been evaluated. Food intake Meals with a high fat content have been shown to reduce the absorption of Rasilez substantially. Pregnancy: There are no data on the use of aliskiren in pregnant women. Rasilez was not teratogenic in rats or rabbits. Other substances that act directly on the RAS have been associated with serious foetal malformations and neonatal death. As for any medicine that acts directly on the RAS, Rasilez should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (See Contraindications). Healthcare professionals prescribing any agents acting on the RAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy. If pregnancy is detected during therapy, Rasilez should be discontinued accordingly. Lactation: It is not known whether aliskiren is excreted in human milk. Rasilez was secreted in the milk of lactating rats. Its use is therefore not recommended in women who are breast-feeding. |
| Adverse Reactions : | Rasilez has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year. The incidence of adverse reactions showed no association with gender, age, body mass index, race or ethnicity. Treatment with Rasilez resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The most common adverse drug reaction is diarrhoea. The incidence of cough was similar in placebo (0.6%) and Rasilez treated (0.9%) patients. The adverse drug reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (1/10); common (1/100, <1/10); uncommon (1/1,000, <1/100); rare (1/10,000, <1/1,000); very rare (<1/10,000), including isolated reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Gastrointestinal disorders: Common: Diarrhoea, Skin and subcutaneous tissue disorders: Uncommon: Rash. Angioedema has occurred during treatment with Rasilez. In controlled clinical trials, angioedema occurred rarely during treatment with Rasilez with rates comparable to treatment with placebo or hydrochlorothiazide. In the event of any signs suggesting an allergic reaction (in particular difficulties in breathing, or swallowing, or swelling of the face, extremities, eyes, lips and/or tongue) patients should discontinue treatment and contact the physician. Laboratory findings In controlled clinical trials, clinically relevant changes in standard laboratory parameters were uncommonly associated with the administration of Rasilez. In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid. Haemoglobin and haematocrit: Small decreases in haemoglobin and haematocrit (mean decreases of approximately 0.05 mmol/l and 0.16 volume percent, respectively) were observed. No patients discontinued therapy due to anaemia. This effect is also seen with other agents acting on the renin-angiotensin system, such as angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers. Serum potassium: Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Rasilez alone (0.9% compared to 0.6% with placebo). However, in one study where Rasilez was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%). Therefore as with any agent acting on the RAS system, routine monitoring of electrolytes and renal function is indicated in patients with diabetes mellitus, kidney disease, or heart failure. |
| Manufacturer : | Novartis |
| Drug Availability : | (POM) |
Free registration to access disease diagnosis, patient management, physician tools.
Only registered users have access to the full EPG Online Knowledge Base including drug search tools, interactive disease Knowledge Centres via the EPG Knowledge Library - with clinical and evidence based physician and research tools, MiMedia (build your own clinical media collection with everything from key opinion leader essays to mode of action videos and other multi-media content), the EPG Survey panel, health news updates and much much more.
Already Registered?
Please log-in now using our member login box.
Not a member?
Don't worry, registration is quick and FREE! We welcome all Healthcare professionals, doctors, nurses and medical students.
Register today to have full access to a wealth of drug data, educational and evidence based interactive guides across all major therapeutic areas, disease management, and clinical tools.
As a practicing Healthcare professional, you can also opt-in to join our market research panel – www.epgsurvey.com – and get paid for sharing your expert clinical opinions!
REGISTER today it only takes a minute! and it's FREE
Having problems?
Use our forgotten password facility or email us at: contact@epgonline.org