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Aliskiren

Class
Antihypertensives
Subclass
Renin inhibitors
Generic name
Aliskiren hemifumarate
Brand names
Tekturna®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Treatment of hypertension
•
Maintenance: 150 mg PO daily
•
Maximum: 300 mg per day
Consider increasing dose to 300 mg if not adequately responding to 150 mg.
Indications for use
Labeled indications
Adults
•
Treatment of hypertension
Safety risks
Boxed warnings
Fetal toxicity
•
Do not use in pregnant patients. Discontinue aliskiren as soon as possible when pregnancy is detected.
Contraindications
Hypersensitivity to aliskiren or its components
Concomitant use of ACEis or ARBs in patients with diabetes
Concomitant use of cyclosporine or itraconazole
Warnings and precautions
Hyperkalemia
•
Use caution in all patients. Monitor serum potassium levels periodically.
Hypotension
•
Use caution in patients with volume or salt depletion or taking other agents acting on the RAAS. Correct volume or salt depletion before initiating aliskiren.
Renal failure
•
Use caution in all patients, particularly with renal artery stenosis, severe HF, post-myocardial infarction, volume depletion, or taking NSAIDs, including selective cyclooxygenase-2 inhibitors. Monitor renal function periodically.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
Use with caution. Monitor renal function. Monitor for hyperkalemia.
Renal replacement therapy
Any modality
•
No dose adjustment required. Use with caution.
Hepatic impairment
Any severity
•
Use acceptable. No dose adjustment required.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans. Discontinue aliskiren when pregnancy is detected.
•
Use of RAAS inhibitors during the second and third trimesters can cause reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, and skeletal deformations, including skull hypoplasia, hypotension, and death.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
↑ serum creatinine, ↑ BUN, arthralgia, ↑ serum CK, cough, diarrhea, dizziness, headache, skin rash, vertigo, asthenia
Uncommon < 1%
•
Anaphylaxis, anemia, ↓ hematocrit, ↓ serum sodium, periorbital edema, gout, hypotension, peripheral edema, ↑ liver enzymes, ↑ serum potassium, ↑ serum uric acid, nephrolithiasis, abdominal pain, seizure, dyspepsia, itching, nausea, vomiting, Stevens-Johnson syndrome, rhabdomyolysis, gastroesophageal reflux disease, toxic epidermal necrolysis, urticaria, angioedema
Interactions
Drug(s)
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