Therapeutic Indications

Aliskiren is indicated for:

Essential hypertension

Irrespective of gender only Adults (18 years old or older)

Aliskiren is indicated for the treatment of essential hypertension in adults.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 150-300 mg once daily

Contraindications

Active ingredient Aliskiren is contraindicated in the following cases:

P-gp inhibitors

No gender/age discrimination

The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-gp inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated.

A single dose interaction study in healthy subjects has shown that ciclosporin (200 and 600 mg) increases Cmax of aliskiren 75 mg approximately 2.5-fold and AUC approximately 5-fold. The increase may be higher with higher aliskiren doses. In healthy subjects, itraconazole (100 mg) increases AUC and Cmax of aliskiren (150 mg) by 6.5-fold and 5.8-fold, respectively.

Co-administration of ketoconazole (200 mg) or verapamil (240 mg) with aliskiren (300 mg) resulted in a 76% or 97% increase in aliskiren AUC, respectively. The change in plasma levels of aliskiren in the presence of ketoconazole or verapamil is expected to be within the range that would be achieved if the dose of aliskiren were doubled; aliskiren doses of up to 600 mg, or twice the highest recommended therapeutic dose, have been found to be well tolerated in controlled clinical trials. Preclinical studies indicate that aliskiren and ketoconazole co-administration enhances aliskiren gastrointestinal absorption and decreases biliary excretion. Therefore, caution should be exercised when aliskiren is administered with ketoconazole, verapamil or other moderate P-gp inhibitors (clarithromycin, telithromycin, erythromycin, amiodarone).

Severe renal impairment

No gender/age discrimination

Administration of aliskiren is not recommended in patients with severe renal impairment (GFR <30 ml/min/1.73 m²).

ACEI, ARB in patients with diabetes mellitus or renal impairment

No gender/age discrimination

The concomitant use of aliskiren with an ACEI or an ARB is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1,73m²).

Breast-feeding

No gender/age discrimination

It is unknown whether aliskiren/metabolites are excreted in human milk. Aliskiren was secreted in the milk of lactating rats. A risk to the newborns/infants cannot be excluded. Aliskiren should not be used during breast-feeding.

Pregnancy

No gender/age discrimination

There are no data on the use of aliskiren in pregnant women. Aliskiren was not teratogenic in rats or rabbits. Other substances that act directly on the renin–angiotensin–aldosterone system have been associated with serious foetal malformations and neonatal death. As for any medicine that acts directly on the renin–angiotensin–aldosterone system, alsikiren 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. Healthcare professionals prescribing any agents acting on the renin–angiotensin–aldosterone system should counsel women of childbearing potential about the potential risk of these agents during pregnancy. If pregnancy is detected during therapy, treatment should be discontinued accordingly.

Hereditary or idiopathic angioedema

No gender/age discrimination

Aliskiren is contraindicated in hereditary or idiopathic angioedema.