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{{Aliskiren}}


{{CMG}}; {{AE}} {{SS}}
<!--Overview-->


'''''For patient information about Aliskiren, click [[Aliskiren (patient information)|here]].'''''
|genericName=
{{SB}} TEKTURNA<sup>®</sup>


==Overview==


'''Aliskiren''' ([[International Nonproprietary Name|INN]]) is a first in class [[renin]] [[enzyme inhibitor|inhibitor]] co-developed by the Swiss pharmaceutical companies [[Novartis]] and [[Speedel]].<ref>{{cite journal |author=Gradman A, Schmieder R, Lins R, Nussberger J, Chiang Y, Bedigian M|title=Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients |journal=Circulation |volume=111 |issue=8 |pages=1012-8 |year=2005 |pmid=15723979}}</ref><!--
|aOrAn=
--><ref>
a
{{cite journal
|author=Straessen JA, Li Y, and Richart T
|title=Oral Renin Inhibitors
|journal=Lancet |volume=368 |issue=9545 |pages=1449-56 |year=2006 |pmid=17055947
|url=http://linkinghub.elsevier.com/retrieve/pii/S0140673606694427}}
</ref>
It was approved by the U.S. [[Food and Drug Administration]] in 2007 for the treatment of [[hypertension]].<ref>{{cite news | url =http://www.cbc.ca/cp/HealthScout/070306/6030611AU.html | title = First Hypertension Drug to Inhibit Kidney Enzyme Approved | date = March 6, 2007|publisher = CBC}}</ref> The trade name for aliskiren is '''Tekturna''' in the USA, and '''Rasilez''' in the UK.
==Category==


Renin inhibitors;Phenol ethers;Cardiovascular Drugs
|drugClass=
==FDA Package Insert==


====TEKTURNA (aliskiren hemifumarate) tablet, film coated ====


'''  [[Aliskiren indications and usage|Indications and Usage]]'''
|indication=
'''| [[Aliskiren dosage and administration|Dosage and Administration]]'''
'''| [[Aliskiren dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[Aliskiren contraindications|Contraindications]]'''
'''| [[Aliskiren warnings and precautions|Warnings and Precautions]]'''
'''| [[Aliskiren adverse reactions|Adverse Reactions]]'''
'''| [[Aliskiren drug interactions|Drug Interactions]]'''
'''| [[Aliskiren use in specific populations|Use in Specific Populations]]'''
'''| [[Aliskiren overdosage|Overdosage]]'''
'''| [[Aliskiren description|Description]]'''
'''| [[Aliskiren clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Aliskiren nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[Aliskiren clinical studies|Clinical Studies]]'''
'''| [[Aliskiren how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[Aliskiren patient counseling information|Patient Counseling Information]]'''
'''| [[Aliskiren labels and packages|Labels and Packages]]'''


==Mechanism of Action==


[[Renin]]is secreted by the kidney in response to decreases in blood volume and renal perfusion. [[Renin]]cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I). Ang I is converted to the active octapeptide angiotensin II (Ang II) by angiotensin-converting enzyme (ACE) and non-ACE pathways. Ang II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings. It also promotes aldosterone secretion and sodium reabsorption. Together, these effects increase blood pressure. Ang II also inhibits [[Renin]]release, thus providing a negative feedback to the system. This cycle, from [[Renin]]through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system ([[RAAS]]). Aliskiren is a direct [[Renin]]inhibitor, decreasing plasma [[Renin]]activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I. Whether aliskiren affects other [[RAAS]] components, e.g., [[ACE]] or non-[[ACE]] pathways, is not known.
|hasBlackBoxWarning=
Yes


All agents that inhibit the RAAS, including [[Renin]]inhibitors, suppress the negative feedback loop, leading to a compensatory rise in plasma [[Renin]]concentration. When this rise occurs during treatment with ACE inhibitors and ARBs, the result is increased levels of PRA. During treatment with aliskiren, however, the effect of increased [[Renin]]levels is blocked so that PRA, Ang I and Ang II are all reduced, whether aliskiren is used as monotherapy or in combination with other antihypertensive agents.
|adverseReactions=




==References==
<!--Black Box Warning-->
{{reflist|2}}


{{Agents acting on the renin-angiotensin system}}
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Intravenous
 
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* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
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<!--Category-->


[[Category:Renin inhibitors]]
[[Category:Phenol ethers]]
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drug]]

Revision as of 10:41, 2 July 2014

Aliskiren
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

Title
See full prescribing information for complete Boxed Warning.
ConditionName: Content

Overview

Aliskiren is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Aliskiren in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aliskiren in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Aliskiren in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Aliskiren in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Aliskiren in pediatric patients.

Contraindications

  • Condition1

Warnings

Title
See full prescribing information for complete Boxed Warning.
ConditionName: Content

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Aliskiren in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Aliskiren in the drug label.

Central Nervous System
Cardiovascular
Respiratory
Gastrointestinal
Hypersensitivity
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aliskiren in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Aliskiren during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Aliskiren with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Aliskiren with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Aliskiren with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Aliskiren with respect to specific gender populations.

Race

There is no FDA guidance on the use of Aliskiren with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Aliskiren in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Aliskiren in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Aliskiren in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Aliskiren in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Aliskiren in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Aliskiren in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Aliskiren in the drug label.

Pharmacology

There is limited information regarding Aliskiren Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Aliskiren Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Aliskiren in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Aliskiren in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Aliskiren in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Aliskiren in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Aliskiren in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Aliskiren How Supplied in the drug label.

Storage

There is limited information regarding Aliskiren Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Aliskiren |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Aliskiren |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Aliskiren in the drug label.

Precautions with Alcohol

Alcohol-Aliskiren interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Aliskiren Brand Names in the drug label.

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "http://www.ismp.org". External link in |title= (help)


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