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Tekturna
Generic Name: Aliskiren
Drug Category: Direct Renin Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 6 years old for a maximum duration of 3 years.
| Approved Uses |
|
indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age and older to lower blood pressure. There are no controlled trials demonstrating risk reduction with Tekturna. Do not use with angiotensin receptor blockers (ARBs) or ACE inhibitors (ACEIs) in patients with diabetes. Tekturna is contraindicated in patients with diabetes who are receiving ARBs or ACEIs because of the increased risk of renal impairment, hyperkalemia, and hypotension. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with creatinine clearance (CrCl) less than 60 mL/min. Hypersensitivity reactions such as anaphylactic reactions and angioedema of the face, extremities, lips, tongue, glottis and/or larynx have been reported in patients treated with Tekturna and has necessitated hospitalization and intubation. Symptomatic hypotension may occur after initiation of treatment with Tekturna in patients with marked volume depletion, patients with salt depletion, or with combined use of aliskiren and other agents acting on the renin-angiotensin- aldosterone system (RAAS). Monitor renal function periodically in patients treated with Tekturna. Changes in renal function, including acute renal failure, can be caused by drugs that affect the RAAS. Safety and effectiveness of Tekturna in patients with severe renal impairment [creatinine clearance (CrCl) less than 30 mL/min] have not been established as these patients were excluded in clinical trials. Monitor serum potassium periodically in patients receiving Tekturna. Drugs that affect the RAAS can cause hyperkalemia. Do not use with cyclosporine or itraconazole. The antihypertensive effect of aliskiren may be attenuated by NSAIDs. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure. Oral co-administration of aliskiren and furosemide reduced exposure to furosemide. The concomitant use of aliskiren with other agents acting on the RAAS such as ACEIs or ARBs is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy. 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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Tekturna as soon as possible. Because of the potential for serious adverse reactions, including hypotension, hyperkalemia and renal impairment in nursing infants, advise a nursing woman that breastfeeding is not recommended during treatment with Tekturna. |
| Off-label Uses |
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• Dosage greater than 300 mg daily in adult and pediatric patients weighing 50 kg or more. GoToSource • Use in patients under the age of 6. GoToSource • Bartter syndrome. GoToSource • Slow progression of HIV-associated nephropathy. GoToSource • Improve parasympathetic function in diabetes. GoToSource |
| Adverse Events |
|
Fetal toxicity and death. GoToSource Angioedema. GoToSource Acute kidney injury. GoToSource Kidney impairment, hypotension and hyperkalemia (high potassium blood levels) when used with angiotensin converting enzyme inhibitors and angiotensin receptor blockers in patients with diabetes. GoToSource Ischaemic stroke. GoToSource Hypertriglyceridemia (elevated triglyceride levels). GoToSource Peripheral edema, bronchitis and nasopharyngitis. GoToSource |
| Litigation |
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Lawsuits filed for strokes, kidney injury and hypotension. |
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