Pharmacologic class: Direct renin inhibitor
Pregnancy risk category C (first trimester), D (second and third trimesters)
FDA Box Warning
• Drugs that act directly on the reninangiotensin system can cause injury and death to a developing fetus.
• Discontinue drug as soon as possible when pregnancy is detected.
Decreases plasma renin activity and inhibits conversion of angiotensinogen to angiotensin
Tablets: 150 mg, 300 mg
Indications and dosages
➣ Hypertension (alone or in combination with other antihypertensives)
Adults: Initially, 150 mg P.O. once daily; may increase to 300 mg if blood pressure isn't adequately controlled
• Concurrent use of angiotensin receptor blockers (ARBs) or ACE inhibitors in patients with diabetes
Use cautiously in:
• patients with severe renal dysfunction, nephrotic syndrome, renovascular hypertension, or history of dialysis
• angioedema (laryngeal edema)
• concurrent use of ACE inhibitors or ARBs in patients with renal impairment (GFR less than 60 ml/minute; avoid use)
• concurrent use of NSAIDs including selective COX-2 inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other drugs that increase potassium levels
• females of childbearing age
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Give consistently with or without food, but not with high-fat foods.
CNS: headache, fatigue
CV: dizziness, hypotension
GI: diarrhea, gastroesophageal reflux
Musculoskeletal: back pain
Respiratory: upper respiratory tract infection, cough
Other: edema, angioedema
Drug-drug. ACE inhibitors, ARBs: increased risk of renal impairment, hypotension, and hyperkalemia
Cyclosporine, itraconazole: significantly increased aliskiren level
NSAIDs (including selective COX-2 inhibitors): increased risk of deterioration of renal function, including possible acute renal failure, and increased aliskiren antihypertensive effect
Drug-diagnostic tests. BUN, creatine kinase, potassium, serum creatinine, serum uric acid: increased values
Hematocrit, hemoglobin: decreased values
Drug-food. High-fat meals: decreased drug absorption
• Stay alert for signs and symptoms of renal dysfunction, especially in patients receiving NSAIDs.
☞ Monitor patient for signs and symptoms of angioedema; discontinue drug if signs and symptoms are present.
• Instruct patient to take drug consistently with or without food, but not with high-fat foods.
• Instruct patient not to stop drug suddenly because doing so could result in uncontrolled high blood pressure.
• Advise female to tell prescriber if she's pregnant or breastfeeding before taking drug.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.
Pharmacologic: renin inhibitors
Time/action profile (antihypertensive effect)
|PO||unknown||2 wk||24 hr|
Adverse Reactions/Side Effects
- abdominal pain
- diarrhea (↑ in females and elderly)
- angioedema (life-threatening)
Drug-Drug interaction↑ risk of hyperkalemia, renal impairment, and hypotension with concurrent use of ACE inhibitors or angiotensin II receptor blockers in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min); concurrent use contraindicated.Blood levels are ↑ by atorvastatin, itraconazole, ketoconazole, verapamil, and cyclosporine ; avoid concurrent use with cyclosporine or itraconazole.May ↓ effects of furosemide.Antihypertensive effects may be ↑ by other antihypertensives, diuretics, and nitrates.↑ risk of hyperkalemia with concurrent use of ACE inhibitors, angiotensin II receptor blockerspotassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes.NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.High fat meals significantly ↓ absorption.
- Monitor BP and pulse frequently during initial dose adjustment and periodically during therapy. Notify health care professional of significant changes. If an excessive fall in BP occurs, place patient in a supine position and administer IV 0.9% NaCl, if necessary. A transient hypotensive response does not contraindicate further therapy.
- Monitor frequency of prescription refills to determine adherence.
- Lab Test Considerations: May cause minor ↑ in BUN, serum creatinine, potassium, uric acid, and creatine kinase.
- May cause small ↓ in hemoglobin and hematocrit.
Potential Nursing DiagnosesNoncompliance (Patient/Family Teaching)
- Correct volume or sodium depletion prior to initiating therapy.
- Oral: Administer at the same time each day without regard to meals.
- Instruct patient to take aliskiren as directed at the same time each day, even if feeling better. Take missed doses as soon as remembered, but not if almost time for next dose. Do not double doses. Do not share medication with others, even with same condition; may be harmful.
- May cause dizziness. Caution patient to lie down and notify health care professional. Also, avoid driving and other activities requiring alertness until response to aliskiren is known.
- Advise patient to report signs and symptoms of angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty swallowing, or breathing) to health care professional immediately.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breast feeding. If pregnancy is detected, discontinue aliskiren as soon as possible.
- Decrease in BP without appearance of side effects. Antihypertensive effect is 90% attained by 2 wk.