Aliskiren

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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]; Associate Editor(s)-in-Chief: Gerald Chi

Disclaimer

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Black Box Warning

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
* When pregnancy is detected, discontinue Aliskiren as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Overview

Aliskiren is a renin inhibitor that is FDA approved for the {{{indicationType}}} of hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, dizziness, headache, and elevated serum creatinine.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension
  • Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
  • Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
  • Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
  • Patients should establish a routine pattern for taking Tekturna with regard to meals. High fat meals decrease absorption substantially.
  • Dosing Information
  • The usual recommended starting dose is 150 mg once daily.
  • In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg.
  • Doses above 300 mg did not give an increased blood pressure response but resulted in an increased rate of diarrhea. The antihypertensive effect of a given dose is substantially attained (85-90%) by 2 weeks.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

Diabetic Nephropathy
  • Dosing Information
  • 300 mg PO qd[1]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness of aliskiren in pediatric patients <18 years have not been established.


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

Off-Label Use and Dosage (Pediatric)

Non–Guideline-Supported Use

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

Contraindications

Warnings

WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
* When pregnancy is detected, discontinue Aliskiren as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Fetal Toxicity
Renal Impairment/Hyperkalemia/Hypotension when Tekturna is given in combination with ARBs or ACEIs
  • Avoid use of Tekturna with ARBs or ACEIs in patients with moderate renal impairment (GFR <60 ml/min).
Anaphylactic Reactions and Head and Neck Angioedema
Hypotension
Impaired Renal Function
Hyperkalemia
Cyclosporine or Itraconazole

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

Tekturna®[2]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Parving, Hans-Henrik; Brenner, Barry M.; McMurray, John J.V.; de Zeeuw, Dick; Haffner, Steven M.; Solomon, Scott D.; Chaturvedi, Nish; Persson, Frederik; Desai, Akshay S.; Nicolaides, Maria; Richard, Alexia; Xiang, Zhihua; Brunel, Patrick; Pfeffer, Marc A. (2012). "Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes". New England Journal of Medicine. 367 (23): 2204–2213. doi:10.1056/NEJMoa1208799. ISSN 0028-4793.
  2. ↑ "TEKTURNA (aliskiren hemifumarate) tablet, film coated [Novartis Pharmaceuticals Corporation]".
  3. ↑ "http://www.ismp.org". External link in |title= (help)


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