Brand Name
Tekturna
Generic Name
Aliskiren
View Brand Information FDA approval date: March 05, 2007
Classification: Renin Inhibitor
Form: Tablet
What is Tekturna (Aliskiren)?
Aliskiren tablets are a renin inhibitor 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, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy
Summary: The aim of this cross-over trial is to assess aliskiren, a direct renin inhibitor, as a novel treatment to block complement activation in the kidneys and thereby attenuate renal disease and stabilize or improve kidney function and compare it to the currently used treatment with the angiotensin converting enzyme inhibitor, enalapril, in patients with the complement-mediated renal disease C3 glomeru...
Related Latest Advances
Brand Information
Tekturna (aliskiren hemifumarate)
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue Tekturna as soon as possible.(
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.(
1DOSAGE FORMS AND STRENGTHS
150 mg light pink biconvex round tablet, imprinted NVR/IL (Side 1/Side 2).
300 mg light red biconvex ovaloid round tablet, imprinted NVR/IU (Side 1/Side 2).
2CONTRAINDICATIONS
Do not use Tekturna with ARBs or ACEIs in patients with diabetes
Tekturna is contraindicated in patients with known hypersensitivity to any of the components
Tekturna is contraindicated in pediatric patients less than 2 years of age because of the risk of high aliskiren exposures identified in juvenile animals due to immaturity of transporters and metabolic enzymes
3DRUG INTERACTIONS
Cyclosporine: Avoid coadministration of cyclosporine with aliskiren [see Warnings and Precautions ( .
Itraconazole: Avoid coadministration of itraconazole with aliskiren [see Warnings and Precautions (
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) including selective Cyclooxygenase-2 inhibitors (COX-2 inhibitors): 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. These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy.
The antihypertensive effect of aliskiren may be attenuated by NSAIDs.
Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS): 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. In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min. Monitor blood pressure, renal function, and electrolytes in patients taking aliskiren and other agents that affect the RAAS [see Warnings and Precautions (
The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated
Furosemide: Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is coadministered with aliskiren.
4ADVERSE REACTIONS
Most common adverse reaction: diarrhea (incidence 2.3%) (
To report SUSPECTED ADVERSE REACTIONS, contact LXO US Inc. at 1-844-800-8007 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
4.1Clinical Trials Experience
The following serious adverse reactions are discussed in greater detail in other sections of the label:
- Fetal Toxicity
- Anaphylactic Reactions and Head and Neck Angioedema
- Hypotension
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following adverse reactions have been reported in aliskiren postmarketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: anaphylactic reactions and angioedema requiring airway management and hospitalization
Urticaria
Peripheral edema
Hepatic enzyme increase with clinical symptoms of hepatic dysfunction
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis
Pruritus
Erythema
Hyponatremia
Nausea, Vomiting
5OVERDOSAGE
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be initiated.
Aliskiren is poorly dialyzed. Therefore, hemodialysis is not adequate to treat aliskiren overexposure
6DESCRIPTION
Tekturna contains aliskiren hemifumarate, adirect renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy- 2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is:
Molecular formula: C
Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.
Tekturna is available as film-coated tablets, which contains 165.75 mg or 331.5 mg aliskiren hemifumerate (equivalent to 150 mg or 300 mg aliskiren) and the following excipients: crospovidone; magnesium stearate; microcrystalline cellulose; povidone; silica, colloidal anhydrous; hypromellose; macrogol; talc; iron oxide, black (E 172); iron oxide, red (E 172); titanium dioxide (E 171).
7HOW SUPPLIED/STORAGE AND HANDLING
Tekturna tablets are supplied as a light-pink, biconvex round tablet containing 150 mg of aliskiren, and as a light-red biconvex ovaloid tablet containing 300 mg of aliskiren. Tablets are imprinted with NVR on one side and IL, IU, on the other side of the 150 mg and 300 mg tablets, respectively.
All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below in
Store at 20°C to 25ºC (68°F to 77ºF); excursions permitted to 15ºC to 30ºC (59 ºF to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture.
Dispense blisters in original container.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (