Summary
The provided statements are general information about fenofibrate and costs and do not align to the FDA-approved Antara (fenofibrate) label excerpts given (indications/dosing/contraindications/safety). Several dosing-strength claims are inconsistent with the label (Antara only lists 43 mg and 130 mg capsules). No label-mapped, auditable Antara-specific prescribing claims were provided.
Category Scores
Accurate Statements
Unsupported Statements
Fenofibrate is a medication used to treat high cholesterol.
Not supported by the provided Antara label excerpts in a directly comparable way (the label indicates adjunctive therapy to diet for severe hypertriglyceridemia and for reducing elevated LDL-C in primary hyperlipidemia when recommended LDL-C lowering therapy is not possible).
Fenofibrate is a medication used to treat high triglycerides.
Not stated in the provided label excerpts as a general description; Antara indication is for severe hypertriglyceridemia (TG ≥ 500 mg/dL) as adjunctive therapy to diet.
Fenofibrate is available in various forms and dosages.
The provided label excerpt only specifies Antara capsules and does not support a claim about other forms/dosages.
Fenofibrate is typically prescribed in specific strengths to manage lipid levels.
The provided label excerpt lists specific Antara capsule strengths (43 mg and 130 mg) but does not support a general prescribing-strength claim as written.
Common dosages of fenofibrate include 54 mg and 160 mg for delayed-release capsules.
Not supported by the provided Antara label excerpt; Antara strengths listed are 43 mg and 130 mg.
Micronized fenofibrate is available in 50 mg, 67 mg, 134 mg, and 200 mg strengths.
Not supported by the provided Antara label excerpt.
Insurance coverage plays a major role in the out-of-pocket cost of fenofibrate.
Not addressed in the provided FDA label excerpts.
For individuals with insurance, copays for fenofibrate can range from a few dollars to over $50 per prescription.
Not addressed in the provided FDA label excerpts.
Without insurance, the cost of fenofibrate can be substantially higher.
Not addressed in the provided FDA label excerpts.
For those paying without insurance, the price of fenofibrate can range from approximately $10 to over $100 for a 30-day supply.
Not addressed in the provided FDA label excerpts.
The price without insurance depends on the pharmacy, the specific formulation, and the dosage.
Not addressed in the provided FDA label excerpts.
Discount cards and pharmacy coupons can often reduce the cost of fenofibrate.
Not addressed in the provided FDA label excerpts.
Discount cards and prescription savings programs can significantly lower the price of fenofibrate for individuals without insurance.
Not addressed in the provided FDA label excerpts.
Prices using discount cards or prescription savings programs can be reduced to as low as $10 to $40 for a month's supply.
Not addressed in the provided FDA label excerpts.
The original patent protection for fenofibrate has long expired.
Not addressed in the provided FDA label excerpts.
Generic versions of fenofibrate are available due to patent expiry.
Not addressed in the provided FDA label excerpts.
Multiple pharmaceutical companies manufacture generic versions of fenofibrate.
Not addressed in the provided FDA label excerpts.
Generic fenofibrate is offered in various strengths and formulations.
Not addressed in the provided FDA label excerpts.
Other medications are available to manage high cholesterol and triglycerides.
Not addressed in the provided FDA label excerpts.
Other fibrates like gemfibrozil are available to manage high cholesterol and triglycerides.
Not addressed in the provided FDA label excerpts as specific listed alternatives.
Other fibrates like bezafibrate are available to manage high cholesterol and triglycerides.
Not addressed in the provided FDA label excerpts as specific listed alternatives.
Statins are available to manage high cholesterol and triglycerides.
Not addressed as a stated alternative therapy in the provided FDA label excerpts.
PCSK9 inhibitors are available to manage high cholesterol and triglycerides.
Not addressed as a stated alternative therapy in the provided FDA label excerpts.
Bile acid sequestrants are available to manage high cholesterol and triglycerides.
The label excerpt includes timing with bile acid binding resins, but does not support this broad alternative-therapy statement.
Contradictions
High
AI Statement
Common dosages of fenofibrate include 54 mg and 160 mg for delayed-release capsules.
Label Reference
Antara label, SECTION 3 DOSAGE FORMS AND STRENGTHS: only 43 mg and 130 mg Antara capsules are listed in the provided excerpt.
High
AI Statement
Micronized fenofibrate is available in 50 mg, 67 mg, 134 mg, and 200 mg strengths.
Label Reference
Antara label, SECTION 3 DOSAGE FORMS AND STRENGTHS: only 43 mg and 130 mg Antara capsules are listed in the provided excerpt.
Important Omissions
Antara-specific FDA label indication language (adjunctive therapy to diet; severe hypertriglyceridemia TG ≥ 500 mg/dL; primary hyperlipidemia LDL-C reduction when recommended LDL-C lowering therapy is not possible) and limitations of use.
Importance:
Moderate
Antara dosing instructions and capsule handling instructions (e.g., 43 mg or 130 mg once daily; swallow capsules whole; do not crush/break/dissolve/chew) and missed dose guidance.
Importance:
Moderate
Key contraindications and warnings relevant to safe prescribing (e.g., severe renal impairment contraindication; active liver disease; pre-existing gallbladder disease; hypersensitivity; hepatotoxicity, myopathy/rhabdomyolysis, pancreatitis).
Importance:
High
Safety Assessment
Potential Patient Risk:
High
Incorrect dosing-strength claims (54/160 mg delayed-release; micronized strengths 50/67/134/200 mg) conflict with the provided Antara label strengths (43 mg and 130 mg). Additionally, the response omits contraindications/warnings and label-specific administration/dosing details.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
High |
Recommendation
Not Aligned
Primary Issue
Stated fenofibrate dose strengths/formulations (54 mg/160 mg delayed-release; micronized 50/67/134/200 mg) are not supported and conflict with the provided Antara (fenofibrate) label excerpt, which lists only 43 mg and 130 mg capsule strengths.
Suggested Improvement
Limit claims to Antara-specific FDA label excerpted information: indications (adjunctive to diet with specified TG/LDL-C criteria), only the Antara capsule strengths (43 mg and 130 mg), and include key contraindications/warnings and correct administration instructions (swallow whole; bile acid resin timing; missed dose guidance).