Aliskiren

DEA Class; Rx

Common Brand Names; Tekturna

• Renin Inhibitors

Direct renin inhibitor
Used for hypertension
Black box warning for pregnancy

Indicated for treatment of hypertension in adults and children ≥6 years

Hypersensitivity

Coadministration with ARBs or ACE inhibitors in patients with diabetes mellitus

Children <2 years

• Diarrhea (2.3%)
• Cough (1.1%)
• Rash (1%)
• Increase in serum creatinine (<7%)
• Hyperkalemia (<1%)
• Angioedema
• Headache
• Gout
• Renal stones
• Seizure
• Severe hypotension
• Rhabomyolysis
• Toxic epidermal necrolysis
• Increase in uric acid
• Angina
• Peripheral edema
• Increased serum creatinine
• Nausea/vomiting
• Hyponatremia

Symptomatic hypotension may occur after initiation of treatment in patients with marked volume depletion, patients with salt depletion, or with combined use of other agents acting on the renin­ angiotensin-aldosterone system (RAAS); the volume or salt depletion should be corrected prior to administration of treatment, or the treatment should start under close medical supervision; transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Monitor renal function periodically; changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS; patients whose renal function may depend in part on activity of the RAAS (eg, patients with renal artery stenosis, severe heart failure, post-myocardial infarction or volume depletion) or patients receiving ARB, ACE inhibitors or nonsteroidal anti-inflammatory drug (NSAID), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)], therapy may be at particular risk of developing acute renal failure; monitor renal function periodically (see Black Box Warnings)

Fetal harm may occur when administered to a pregnant woman

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

There is no information regarding the presence of aliskiren in human milk, the effects on the breastfed infant, or the effects on milk production