Brand Name(s):Rasilez




Review Date:Aug-24

Aliskiren (Rasilez): Combination use of medicines from different classes of renin-angiotensin system blocking agents: risk of hyperkalaemia, hypotension, and impaired renal function-new warnings

Advice for healthcare professionals:
* Combination use of medicines from two classes of RAS blocking agents (ACE-inhibitors, ARBs, or aliskiren) is not recommended.
* In particular, prescribers are advised not to give patients with diabetic nephropathy an ACE-inhibitor with an ARB since they are particularly prone to developing hyperkalaemia.
The combination of aliskiren with an ACE-inhibitor or ARB is contraindicated in patients with kidney impairment or diabetes.
Patients with heart failure
* Some patients with heart failure may have a medical need for treatment with an ACE-inhibitor and an ARB. Candesartan and valsartan are licensed as add-on therapy to ACE-inhibitors for people with symptomatic heart failure who require such a combination despite optimal therapy.
* The triple combination of an ACE-inhibitor, ARB, and a mineralocorticoid receptor antagonist or other potassium-sparing diuretic is not recommended.
Patients currently taking a combination of RAS blocking agents
* Review the treatment of all patients currently taking a combination of RAS blocking agents at a routine appointment. Carefully consider if combination use is appropriate.
* If combination use is considered absolutely necessary, it must be carried out under specialist supervision and with close monitoring of blood pressure, renal function, and electrolyte levels (particularly potassium). Consider monitoring patients when combination use is started and on a monthly basis thereafter, and also after changing dose and during intercurrent illness.

MHRA DSU June 2014

Aliskiren (Rasilez): risk of cardiovascular and renal adverse reactions-new contraindications and warnings
The combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) has been associated with serious adverse cardiovascular and renal outcomes in a recent large clinical trial (ALTITUDE). This combination is now contraindicated in: diabetic patients (type I or type II); and non-diabetic patients with an estimated glomerular filtration rate (eGFR) <60 mL/min per 1*73 m2 In all other patient groups, aliskiren in combination with an ACE inhibitor or an ARB is not recommended Any use of aliskiren (either as monotherapy or in combination with other medicines) is no longer recommended in any patient with severe renal impairment: eGFR <30 mL/min per 1*73 m2 MHRA Drug Safety Update March 2012 (Volume 5, Issue 8) .............................. European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study - interim advice provided Aliskiren (Rasilez) is a direct renin inhibitor approved for the treatment of essential hypertension. The ALTITUDE study was conducted in 8,606 type 2 diabetic patients at high risk of adverse heart and kidney events. Aliskiren 300 mg was given in addition to an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). In most patients blood pressure was adequately controlled before they participated in the study. The study was stopped because of preliminary interim analyses showing that study patients were unlikely to benefit from aliskiren. Furthermore, there was a higher incidence of adverse events related to non-fatal stroke, kidney complications, high blood potassium and low blood pressure. Additional analyses from ALTITUDE are ongoing and updated advice may be issued early in 2012. MHRA 22/12/11 .............................. NSAIDs may reduce the antihypertensive effect of aliskiren. Elderly patients or patients with compromised renal function may be at risk of further deterioration of renal function if NSAIDs and aliskiren are used together MHRA Update Volume 2 Issue 10 May 2009 Aliskiren is a new antihypertensive drug that acts by directly inhibiting renin. Data from brief studies suggest that it reduces blood pressure to a similar extent as angiotensin converting enzyme (ACE) inhibitors or angiotensin-II receptor antagonists. However, there are no published data on the long-term use of aliskiren or its effect on cardiovascular outcomes, and it is more expensive than most other antihypertensive drugs. On current evidence, there is no justification for using aliskiren in preference to the many effective and longer-established alternative treatments. DTB review OCTOBER 2008