Sacubitril and Valsartan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: AKT
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Black Box Warning
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FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
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Overview
Sacubitril and Valsartan is a combination of a neprilysin inhibitor and an angiotensin II receptor blocker that is FDA approved for the prevention of of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, increased serum potassium, hyperkalemia, and increased serum creatinine.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
Dosing Information
- ENTRESTO is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor. If switching from an ACE inhibitor to ENTRESTO allow a washout period of 36 hours between administration of the two drugs.
- The recommended starting dose of ENTRESTO is 49/51 mg twice-daily.
- Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
- Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents
- A starting dose of 24/26 mg twice-daily is recommended for patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents. Double the dose of ENTRESTO every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
- Dose Adjustment for Severe Renal Impairment
- A starting dose of 24/26 mg twice-daily is recommended for patients with severe renal impairment (eGFR <30 mL/min/1.73 m2). Double the dose of ENTRESTO every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
- No starting dose adjustment is needed for mild or moderate renal impairment.
- Dose Adjustment for Hepatic Impairment
- A starting dose of 24/26 mg twice-daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification). Double the dose of ENTRESTO every 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
- No starting dose adjustment is needed for mild hepatic impairment.
- Use in patients with severe hepatic impairment is not recommended.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sacubitril and Valsartan in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sacubitril and Valsartan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Sacubitril and Valsartan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Sacubitril and Valsartan in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sacubitril and Valsartan in pediatric patients.
Contraindications
There is limited information regarding Sacubitril and Valsartan Contraindications in the drug label.
Warnings
|
FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
|
There is limited information regarding Sacubitril and Valsartan Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Sacubitril and Valsartan Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Sacubitril and Valsartan Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Sacubitril and Valsartan Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Sacubitril and Valsartan in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sacubitril and Valsartan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Sacubitril and Valsartan during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Sacubitril and Valsartan in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Sacubitril and Valsartan in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Sacubitril and Valsartan in geriatric settings.
Gender
There is no FDA guidance on the use of Sacubitril and Valsartan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Sacubitril and Valsartan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Sacubitril and Valsartan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Sacubitril and Valsartan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Sacubitril and Valsartan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Sacubitril and Valsartan in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Sacubitril and Valsartan Administration in the drug label.
Monitoring
There is limited information regarding Sacubitril and Valsartan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Sacubitril and Valsartan and IV administrations.
Overdosage
There is limited information regarding Sacubitril and Valsartan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Sacubitril and Valsartan Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Sacubitril and Valsartan Mechanism of Action in the drug label.
Structure
There is limited information regarding Sacubitril and Valsartan Structure in the drug label.
Pharmacodynamics
There is limited information regarding Sacubitril and Valsartan Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Sacubitril and Valsartan Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Sacubitril and Valsartan Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Sacubitril and Valsartan Clinical Studies in the drug label.
How Supplied
There is limited information regarding Sacubitril and Valsartan How Supplied in the drug label.
Storage
There is limited information regarding Sacubitril and Valsartan Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Sacubitril and Valsartan Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Sacubitril and Valsartan 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 Sacubitril and Valsartan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Sacubitril and Valsartan Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.