Summary
Only the pregnancy fetal toxicity warning claim is directly supported by the provided FDA label text. Other claims (indications, mechanisms, and pricing/savings information) are not supported or not addressable using only the supplied label excerpts, resulting in substantial unsupported/unspecified content.
Category Scores
Accurate Statements
WARNING: FETAL TOXICITY (fetal harm / injury risk during pregnancy; discontinue when pregnancy is detected).
Supported by label sections 5.1 and 8.1 (ENTRESTO can cause fetal harm; when pregnancy is detected, consider alternative treatment and discontinue ENTRESTO) and referenced in 17 (pregnancy counseling).
Unsupported Statements
Entresto is a prescription medication used to reduce the risk of death and hospitalization in people with chronic heart failure with reduced ejection fraction.
Not supported by the provided label excerpts (only fetal toxicity/pregnancy counseling content was supplied).
Entresto is used to treat high blood pressure.
Not supported by the provided label excerpts.
Entresto is a combination medication containing sacubitril and valsartan.
Not supported by the provided label excerpts (ingredients were only included in the prompt metadata, not in the supplied label text sections).
Sacubitril is a neprilysin inhibitor.
Not supported by the provided label excerpts.
Valsartan is an angiotensin II receptor blocker (ARB).
Not supported by the provided label excerpts.
Sacubitril and valsartan work together to relax blood vessels.
Not supported by the provided label excerpts.
Sacubitril and valsartan work together to lower blood pressure.
Not supported by the provided label excerpts.
Sacubitril and valsartan work together to reduce the strain on the heart.
Not supported by the provided label excerpts.
As of late 2023, there are no generic versions of Entresto approved by the U.S. Food and Drug Administration (FDA).
Not supported by the provided label excerpts.
Without insurance, a 30-day supply of Entresto can range from approximately $400 to over $500.
Not supported by the provided label excerpts.
With insurance, co-pays for Entresto can range from $10 to $70 per month.
Not supported by the provided label excerpts.
For individuals with Medicare Part D, the cost of Entresto might be higher during the coverage gap or out-of-pocket phase.
Not supported by the provided label excerpts.
The manufacturer of Entresto, Novartis, offers a savings program that can help eligible patients reduce their co-pay costs.
Not supported by the provided label excerpts.
For those with commercial or private insurance, the savings program can bring the monthly cost of Entresto down to as low as $10.
Not supported by the provided label excerpts.
Patients without commercial insurance are generally not eligible for the Novartis savings program.
Not supported by the provided label excerpts.
Contradictions
Important Omissions
No additional label-based pregnancy management details are included in the response set beyond the single fetal toxicity/discontinue-on-detection statement (e.g., serial ultrasound, neonatal monitoring, and specific neonatal interventions described in 5.1/8.1).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Only one safety-relevant claim (fetal toxicity/discontinuation on pregnancy detection) is supported by the supplied label excerpts. Other claims include nonsupported information (e.g., pricing/savings and indications/mechanism), which cannot be verified against the provided label and could distract from label-consistent pregnancy risk communication.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Moderate |
Recommendation
Partially Aligned
Primary Issue
Most claims made are not supported by the supplied FDA label excerpts (which only cover fetal toxicity/pregnancy counseling).
Suggested Improvement
Limit statements to the provided label-supported content (fetal toxicity/pregnancy-related counseling and management) or supply the relevant additional label sections for indication/mechanism, and avoid unverifiable pricing/savings statements.